Mary Jo Lamberti, PhD

Decentralized clinical trials (DCTs) have accelerated in response to the pandemic and continue to evolve. As a result, sponsor companies and contract research organizations (CROs) working in collaboration have been re-evaluating their relationships, especially in terms of structure, costs, and effectiveness. Much of the research examining DCTs and hybrid trials has tracked increases in usage but has not specifically addressed the impact on sponsor-CRO relationships. In an examination of worldwide trials, researchers noted a 50% increase in global drug trials with a DCT or virtual element from 2020 to 2021 and a 28% increase from 2021 to 2022.

Other surveys have noted growth in the implementation of DCTs, but greater usage projected for three years out.

Research conducted with pharmaceutical industry professionals on the use of DCTs and hybrid elements after the COVID pandemic found that in a survey of 245 investigators, 104 investigators in the U.S. indicated that telemedicine (74%), remote patient monitoring (77%), and remote site-initiation visits (63%) would increase.

 Other studies report increasing use of electronic health records or prevalence and use of DCTs in numerous therapeutic areas.

Various challenges to the use of DCTs have been cited including data standards, country-to-country regulations, and the need for clarity in regulatory guidance. Data privacy issues are also notable considerations. Other hurdles are seen in data quality for apps, wearables and ePRO which require clinical and technical validation. Another barrier is patients’ lack of familiarity with technology which can hinder implementation.

Pricing models, approaches to the implementation of DCTs, and management of vendors impact sponsor-CRO partnerships. Research has been sparse on this topic, with a few published articles addressing the critical need for partnering with the right CROs and vendors.

 In addition, the need for novel partnerships to streamline processes and improve upon data sharing have been cited.

 Others have noted the need for multi-stakeholder collaboration across the biopharmaceutical industry to promote best practices and drive adoption.

 As sponsor-CRO partnerships expand their collaboration, the need grows to examine the impact of DCTs and hybrid trials. To assess this impact and gather additional research, Tufts CSDD initiated a study in collaboration with ten biopharmaceutical organizations and CROs.

The study assessed how approaches to decentralized and hybrid trials disrupt sponsor-CRO relationships including evaluating strategies and approaches to oversight and performance. The study was comprised of a two-part methodology including an assessment of the current landscape through interviews with the working group and a global industry survey. The interviews identified the primary sponsor-CRO relationship areas that were most disrupted by DCT solutions, while the survey assessed the current landscape and gathered insights into how organizations are responding and adapting to these relationships. Tufts CSDD researchers conducted interviews with representatives of the working group companies in the summer of 2021 and the results informed the development of the survey.

A global web survey examined the overall impact of decentralized and hybrid trials including implementation of specific technologies and solutions and those that organizations have most effectively implemented. Definitions were provided at the beginning of the survey.* Pharmaceutical and biotechnology respondents evaluated a CRO’s ability to manage specific solutions and technologies indicating the degree to which their oversight was executed satisfactorily and their opinions about the cost of implementation. In addition, the survey examined pricing models and areas of challenge implementing decentralized or hybrid trials with CROs and vendors. The survey also assessed metrics and performance, training, and overall perceptions about the future of trials.

The survey was launched in February 2022 to a diverse group of clinical research professionals and in coordination with DTRA (Decentralized Trials and Research Alliance, dtra.org) and 

An e-mail invitation containing a link to the survey was distributed. The survey closed in April 2022 with 80 completed responses. Three-quarters of respondents represented pharmaceutical, biotech companies and CROs (Table 1). A majority (60%) worked in clinical operations or clinical development roles and in mid-sized or small companies (59%), while 41% were from large companies.​

Respondents reported that on average, their organizations conducted 84 trials in 2020 and 88.5 trials in 2021 (Table 2). An estimated 21% were identified as DCTs or hybrid trials in 2020 and 30% in 2021. The percentage increase in decentralized or hybrid trials from 2020 to 2021 was not statistically significant.​ Three-quarters of the pharmaceutical/ biotechnology survey respondents indicated that they were decision-makers in the process of selecting DCT CROs and vendors and 90% of those reported using at least 3 preferred providers.

Usage and implementation of DCT and hybrid solutions and technologies

Prior to the pandemic, the largest number of respondents reported usage of ePRO (n=35), eDiaries (n=34) and eCOA (n=33) (Table 3). Currently, remote monitoring (n=38), ePRO (n=36) and eConsent (n=35) are the DCT technologies used by the greatest number of respondent organizations. The DCT technologies most frequently reported as effectively implemented were ePRO (n=30), eCOA (n=29), and remote monitoring (n=29).

A majority (40 of 50 respondents) indicated that remote monitoring impacted their organizations and would remain the predominant approach after the pandemic (29 of 54 respondents). The fewest respondents rated the following solutions as effectively implemented (Table 4): home health services (n=15), wearables or sensor data collection (n=9), and electronic medical record (EMR)/electronic health record (EHR) data integration (n=7). More respondents planned to use EMR and EHR data integration (n=22), wearables or sensor data collection (n=21), direct-to-patient or home IP drug shipments (n=21), and eConsent (n=20).

A high percentage of pharmaceutical and biotechnology respondents indicated that CROs were able to manage decentralized lab work including local labs (n=47 of 54 respondents), direct-to-patient (home IP drug shipments) (n=45), and eConsent (n=45) satisfactorily (‘Very Well’ or ‘Somewhat Well’). In implementing DCT and hybrid trials with CROs and vendors, major or moderate barriers commonly identified were country challenges (n= 49 of 54 respondents); different site capabilities (n=45); and data collection challenges including quality, integrity, oversight, and ownership (n=45). Other obstacles included resistance to change (n=44) and managing multiple vendors (n=43).

In evaluating the costs of DCTs compared to traditional trials (Table 5), 28 (of 52 respondents) indicated that DCTs are more expensive, while 17 felt they are about the same and 7 reported they are less expensive. Asked about the future of DCTs, 23 respondents (of 51) indicated they expected the cost to increase, 13 expected the cost to remain about the same, and 15 expected the cost to decrease.

A comparison of the top five outsourced expenses in the time period from before the pandemic to the top five outsourced expenses in early 2020 (Table 6) yielded the same expenses, although remote monitoring moved up from fifth to second most expensive in the ranking in early 2020.

Pricing models reported by respondents before and after COVID appear to be mixed with fixed unit pricing (i.e., pricing based on completion of tasks) (26 before COVID and 23 respondents currently using) and fixed pricing (i.e., pricing that guarantees a fixed budget) at the study level (25 before COVID and 21 respondents currently using) as most prevalent. Fewer respondents indicated using incentive-based pricing or fixed pricing at the portfolio level.

A majority of pharmaceutical and biotech respondents (n=44) gave favorable ratings of CROs, indicating CROs were either somewhat or very proactive in DCT adoption (Table 7). Only 18 respondents indicated that CROs were not proactive. Fifty respondents perceived that DCTs or hybrid trials had a moderate or significant positive influence on sponsor-CRO collaborations, while 12 believed they had a moderate negative influence.

Similarities emerged among the key performance indicators (KPIs) used to evaluate sponsor-CRO relationship effectiveness and vendors implementing DCT solutions. The top performance metrics for sponsor-CRO relationships were patient compliance, study startup, first patient first visit, enrollment, and last patient last visit to data base lock. For DCT vendors, the top performance metrics were enrollment, final actual contract as a percent of initial contract value, first patient first visit, last patient last visit to database lock, study startup, and study startup to last patient last visit.

Training responsibilities were also consistent for sponsors and CROs/vendors with approximately three-quarters of respondents noting that sponsors and CROs/vendors were responsible for training site staff, study teams, or both. There were no differences found among respondents by company size. The results also showed preferences for online and virtual approaches (n=60) as well as written documents and manuals (n=42) over in-person sessions (n=29).

In examining perceptions about outsourcing DCTs and hybrid trials over the next three to five years, 38 (of 51 respondents) indicated that outsourcing would likely increase due to advanced technologies (Table 8). Seven indicated usage would remain the same and four felt it would likely decrease due to complications and challenges. Similarly, 44 respondents (of 52) anticipated the use of CROs and vendors that implement DCT solutions will increase as more solutions become available. Only four believed usage would likely decrease as companies consolidate, and three felt that outsourcing would remain the same.

Respondents offered varied opinions about the role of the CRA in the future. Nearly half of respondents (24 of 51) indicated that CRA roles will increase with remote work, while 20 felt that the numbers would decrease. Of those indicating a decrease, 14 felt more technological expertise and skills will be required and 6 perceived travel benefits would be curtailed. Few respondents reported increased CRA turnover due to burnout and additional time on the job, or that the role would remain unchanged.

Although remote monitoring, ePRO and eConsent were the DCT technologies currently used by the greatest number of respondents, the results also indicated that only slightly more than half of those responding rated ePRO, eCOA and remote monitoring as effectively implemented by their organizations. This finding may reflect challenges with implementation or investments required early on in the study. Published research indicates that assessing ePRO technology to ensure its usability and acceptability for patients is critical.

 Further, eCOA has numerous logistical considerations and may require added time and funding upfront, especially in terms of determining scientific requirements and qualifying suitable vendors.

Looking at the same DCT technologies, a surprisingly small number of respondents indicated that they planned to use the technologies in the future. While the current study shows that fewer than half of respondents planned to use any individual technology in the future, surveys conducted during the pandemic indicated that the vast majority of respondents expected to use these technologies in future studies.

 It may be that the general excitement surrounding these technologies is waning as organizations encounter the challenges of implementation and costs.

Relatively small numbers of respondents rated their company’s implementation of home health services as effective. Staffing shortages due to the pandemic have impacted these services and wide variation in costs could affect usage. Respondents’ ratings of the effectiveness of telemedicine were also fairly low relative to other technologies assessed. This finding could perhaps be due to decreasing usage with easing COVID restrictions. There could, however, be other factors that hinder efficiencies such as requirements of swift reporting of adverse events, necessary documentation and follow up.

The primary barriers reported with implementation of DCT and hybrid trials by CROs and vendors include country challenges, varied site capabilities with respect to novel technologies, and data collection. These challenges are consistent with published data on this topic (2,3,6). Resistance to change and managing multiple vendors were also among the top five implementation hurdles. The latter are expected given that much of the technology is novel, and the disruption brought about by a multitude of innovative solutions, especially at investigative sites could be staggering. In addition, the number of CROs and vendors which companies must manage has increased substantially. With the expansion of solutions globally and variation in country regulations, there are additional considerations such as data privacy and security, lack of regulatory frameworks and harmonization, and legal policies that can hinder implementation. Use of multiple data sources can also challenge the integrity of data and clarity regarding ownership of data.

The majority of biopharma respondents rated CROs favorably for maintaining a proactive role in DCT adoption. In addition, respondents indicated that DCTs or hybrid trials had a significant or moderate positive influence on sponsor-CRO collaborations. Although viewed as currently more expensive with anticipated cost increases, the majority of respondents indicated that both outsourcing of these trials will increase as well as the use of CROs and vendors that implement such solutions.

Follow up research can potentially identify specific examples of relationship models due to disruptions by hybrid and decentralized trials. An in-depth study of use cases across organizations would be invaluable and could clarify ways in which these sponsor-CRO partnerships continue to transform.

Decentralized clinical trials use technologies and other solutions to create options for participation outside of conventional clinical settings, improving access and convenience.

Hybrid trials use a mix of elements from traditional clinical trials and decentralized clinical trials

Remote monitoring is conducted off-site. A remote evaluation that is carried out by sponsor personnel or representatives at a location other than the sites at which the clinical investigation is being conducted.

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Articles

Tufts CSDD study in collaboration with ten biopharmaceutical organizations and CROs examines sponsor/CRO relationships.

The Impact of Decentralized and Hybrid Trials on Sponsor and CRO Collaborations

Since the release of the first ICH E6 Good Clinical Practice guidance in 1996, outlining international standards in the design, recording, and reporting of clinical trial data, technological advances in drug development have made it possible to conduct more clinical trial activities remotely and in patients’ homes. Although a revision to this earlier guidance was released in 2016 (ICH E6 R2), there has since been increasing adoption of decentralized clinical trials, as well as more use of technology given the COVID-19 pandemic. As investigative sites conduct more decentralized and hybrid trials, data collection is increasingly falling to the patient (e.g., wearable devices, smart phones). Stakeholders have expressed concerns about the impact of this trend on protocol complexity and patient participation burden during trials. The principles and guidelines in ICH E6(R2) influence the complexity of trial protocols and, by extension, the burden of data collection, validation, and reporting on investigative site staff and patients. Although the ICH E6(R2) guidance is meant to protect the “rights, safety, and well-being of trial subjects,” it does not sufficiently address the patient’s growing role or the roles of the many vendors and third parties that have entered the market.

The ICH E6 guidance is currently being revised (ICH E6 R3), and the industry has yet to see how this new iteration will approach oversight of these emerging external stakeholders. The goal of this study is to provide insight on ICH E6 revisions that could improve clinical trial operating activity by incorporating the patient’s changing role and those of the many stakeholders, including new entrants into the pharmaceutical industry.

The Tufts Center for the Study of Drug Development (Tufts CSDD) conducted a study in collaboration with MaxisIT, a technology solutions provider.* In early 2021, Tufts CSDD examined and identified areas in the ICH E6(R2) guidance document that fall short in accommodating the role of patients/study volunteers as partners in clinical data collection. To gather in-depth perspectives on these topics, Tufts CSDD facilitated three 2-hour virtual listening sessions in March 2021 among 20 clinical operations, data management, and regulatory affairs executives. A 2-hour virtual roundtable discussion was later held in mid-June 2021 to review the results of the listening sessions, gather additional insights from listening session participants, and add new voices and perspectives to the research. A total of 26 individuals attended the roundtable. Finally, Tufts CSDD interviewed six roundtable attendees during the summer of 2021 with relevant and extensive backgrounds in clinical trial regulation and development to expand upon the findings from previous discussions.

One pervasive issue that emerged during the interviews and discussions is the increased patient and study staff burden when unfamiliar technology is utilized for a trial. Although awareness and knowledge among the general public surrounding basic technology has grown exponentially in the last 10 years, patient and study staff burden can increase when the technology is sophisticated or has an interface that is unfamiliar. As a result, patient and study staff capabilities differ by trial, site, and geographic area, so the use and type of technology should be centered around the individual patient as well as the site capabilities.

One suggestion for decreasing knowledge-based patient burden when patients are oversight partners in a trial is adhering as much as possible to existing standards of care. For example, a diabetes patient participating in a diabetes-related clinical trial will have certain familiarity and capability around medical instruments and procedures more than a “healthy participant.” Whenever possible, responsibilities placed on the patient should adhere to the existing standard of care for the given disease.

Collecting feedback from trial participants and sites is another important way to prevent burden in future trials or improve the level of burden in ongoing trials. Some sponsors have struggled to effectively collect feedback from patients due to confidentiality concerns, or simply do not have feedback mechanisms available. A few participants from larger sponsor companies discussed channels in place for some trials that collect feedback from patients and sites during the study design process, throughout the treatment duration, and following the end of the trial. Such feedback channels can potentially decrease patient burden by adhering to what the patients believe is burdensome. However, these feedback channels have not been widely implemented and it will take time for sponsors to not only establish these mechanisms but also to learn to accurately interpret and cater to the patients’ needs.

A consistent theme surrounding patient burden and data collection is to only collect data that is critical to the trial and avoid extraneous protocol data collection. Although guidance in this area has been established, further clarity surrounding the restriction of extraneous data collection in ICH E6(R3) could decrease burden for the patient and the site. Other basic guidelines that currently exist may contribute to resolving this issue, such as ICH E8, which encourages patient feedback and input into study design.

During trials in which patients collect their own data and provide oversight, monitoring professionals still must review all patient activities and data. Discussions and interviews revealed concerns about how monitoring professionals can identify relevant data; validate the data; and integrate new technology in this process. Though we have yet to see how many companies will revert to on-site monitoring after the pandemic and how many will continue with decentralized models, multiple participants stated that they think many companies will return to on-site monitoring. Some of these are smaller sponsors without the technology to continue remote monitoring. Others might have a new system that relies on CRO partners, and internal staff may not be familiar with the technology. If on-site monitoring returns, the development of a remote monitoring process that allows monitoring professionals to overcome the challenges that accompany patient-collected data and patient oversight practices could be delayed until the use of decentralized trial models is more established among both large and small sponsor organizations.

Training and technological solution standardization were proposed as resolutions for decreasing burden on both patients and study staff and was discussed extensively throughout the listening sessions, roundtable, and interviews. Although there were mixed thoughts on the effectiveness of training in patient data collection and incorporating new technology systems, most participants agreed that training helps, but it should not be the only solution when confronted with these challenges. The simplicity and clarity of processes and systems, among others, are also important factors.

ICH E6(R3) should focus on data quality and patient engagement—in this case, patient engagement could mean patients have input into study design or aspects of data quality and verification. Additionally, throughout this study participants have discussed the detrimental focus on 100% SDV among sites. ICH E6(R3) should further highlight risk-based monitoring over 100% SDV, as monitoring and validating patient-collected data with 100% SDV would be difficult to carry out and would increase burden on the site and the patient.

Many participants discussed lack of system standardization across sponsors and its effect on the site’s ability to collect data and conduct trials quickly and effectively. Systems can also differ across sponsor organizations or departments within the same organization, creating confusion and additional burden for sites that have to navigate learning various systems for the same purpose. Although select vendors’ products are commonly used by most sites, there is rarely only one system that sites and patients are required to use.

Some participants in the roundtable and interviews did not see any resolution to the lack of standardization and vendor agnostic** solutions. The discussions clarified the different needs and operations across sponsors and sites, which has led to adoption of hybrid technology solutions. According to participants, implementing one system with the same capabilities across every site has not been feasible, as some level of customization is necessary for most trials. Participants expressed a need for integration and standardization of systems, however, and sponsors have not yet made the move to adopt or build centralized data platforms to improve their ability to maintain oversight and collaborate. Despite various limitations and evolving scenarios, standardization is still an important topic, and some steps can be taken to minimize the cost and time burden as well as potential risks resulted from delayed data that lack of standardization causes. One of these steps involves focusing on strategy or more efficient processes for using vendor agnostic technology when attempting to standardize systems. For example, sponsors could potentially standardize their processes so sites can more easily train for and adhere to methods across sponsors. Technology solutions should then be able to support these new methods. This process has occurred previously with GCP/ICH training, where study staff training with one sponsor can be applied to multiple sponsors across trials.

Participants did not think standardization was applicable to ICH E6, and in fact some were concerned that addressing this problem in the guidance could hinder innovation and make it more difficult for sites to operate. Standardization must occur among sponsor organizations with the focus of alleviating site burden. However, the guidance can help by implementing guidelines around topics such as third-party vendor oversight that encourage standardization of processes among sponsors, which could potentially lead to system standardization.

Leaving room for innovation in ICH E6 guidance

A common thread of conversation throughout the course of the research was maintaining simplicity and flexibility in the ICH guidance in order to be widely applicable across sites. However, a more general version of the guidance may result in variation of its interpretation among sponsors and sites. Some participants said that misinterpretation can increase burden because sites do not know what the regulator will look for during inspections. This confusion over the requirements influences the implementation of 100% SDV and other unnecessary and time-consuming tactics.

Regulators can prevent misinterpretations by providing transparency around the focus of inspections, making it easier for sites to adhere to these requirements. Additionally, industry groups and institutions can contribute to a general understanding of the guidance that will help those sites or sponsors struggling to achieve clarity in the interpretation.

The ICH E6(R3) guidance that is being developed is currently a collaborative effort with professionals from a variety of clinical trial fields incorporating their insights. This effort could contribute to a more widely interpretable document. Providing transparency on the guidance’s base principles while not being too didactic or restrictive can also leave room for innovation within the space of clinical research.

The main barriers to incorporating patients as oversight partners in clinical trials—and the acknowledgement of patients as stakeholders in the ICH E6 guidance—include the absence of technology standardization between and within sponsors and sites, protocols that overburden patients or require gathering extraneous data, and industry silos. The pharmaceutical industry is unlikely to adapt quickly to the needs of remote and hybrid trials and patients overseeing their own data collection because these barriers prevent quick turnaround. Therefore, it will take time and multiple research initiatives for the idea of patients as oversight partners to become commonly accepted and implemented throughout the industry.

ICH E6(R3), which is scheduled for release later this year, is expected to address the rapid innovations in technology and design that impact the conduct of trials. The guidance can also help encourage adaptation by considering the needs of sponsors and sites and allowing for flexibility in conducting trials. According to participants in this study, innovation is not driven by regulations. Instead, regulations create a minimum standard of quality and care in a clinical trial, and the more flexible regulations are, the more space there is for innovation among sponsors and sites.

Efforts to incorporate patients as oversight partners while addressing these potential drawbacks include training, collection of patient feedback, system standardization, vendor agnostic data platforms and maintaining an open channel of communication between the site and the patient. Although these solutions also contribute to mitigating the increase of patient and study staff burden, many sponsors have not, or state that they are not currently capable of, implementing them. Additionally, despite the higher use of digital processes and remote trial solutions during the COVID-19 pandemic, participants in this study anticipate that many sponsors will likely return to pre-pandemic standards as a result of lack of infrastructure and resources. Although patient oversight approaches have a strong place in the future of clinical trial technology, progress must be made before the industry is ready to adopt.

*This research study was funded by MaxisIT.

** In this article, vendor agnostic solutions/technology refers to a solution/technology that is generalizable, so it is interoperable among various systems.

Note: The authors would like to acknowledge Monique Garrett of PrismWorks for her contribution to this article.

Research Analyst, Tufts CSDD and School of Medicine Development, 

Professor and Associate Director, Tufts CSDD and School of Medicine Development, 

Deputy Director, Research Professor, Tufts CSDD and School of Medicine

Improving receptivity and response to the evolving nature of clinical trial patient oversight.

Assessing Sponsor and CRO Awareness

Remote and virtual clinical research team collaboration has been a defining characteristic of global drug development activity during the pandemic. This article, based on research conducted between September 2020 and April 2021, summarizes how organizations approached adapting to remote operating models and the associated experiences and effectiveness of clinical research professionals managing their roles and responsibilities.

The goal of this article is to provide insight into lessons learned, and to guide considerations about the future of remote team collaborations within biopharmaceutical companies and other stakeholders in the clinical research enterprise.

The results reveal that drug development professionals have been mostly satisfied with their organizations’ remote preparedness and responsiveness and feel supported by their managers and organizations. In addition, clinical research professionals operating remotely during this global health crisis perceive that their productivity and effectiveness levels have been high, and the majority wish to continue to work remotely. The results also show that there are areas requiring attention: 55% of respondents reported feeling burned out and 42% reported that connections with colleagues had deteriorated.

Tufts CSDD research conducted early in the pandemic

 captured the variety of remote and virtual approaches being utilized. As expected, communication technologies—including video conferencing, cloud-based file sharing and telehealth—were the predominant approaches being used by clinical teams. Other widely used solutions—largely out of necessity—supporting clinical trial activities included eConsent and remote monitoring. 

A study conducted at the Cleveland Clinic Cancer Center

, revealed some key benefits of remote work and its impact on the execution of clinical research. The findings are based on analysis of productivity data sourced from a remote research coordinator (RC) pilot program that started one week prior to the onset of the pandemic. By March 25, 2020, all research coordinators at the Cancer Center were part of the program and working from home. The data collected revealed that the productivity and efficiency of RCs during at-home days was higher compared to in-office days. The program allowed for higher and better data entry, an increase in the number of trials initiated, and a reduction in trial times to initiate a trial compared to a similar time-period in 2019. An uptick in team morale was also observed. Nearly all members of the 60-person team expressed gratitude for their ability to work at home. Notable benefits included reduced stress and burden from commuting, parking, and fuel costs. Additionally, the work-from-home model correlated with reductions in team turnover.

Employee reports of productivity across industries during the pandemic have been extremely positive. Several studies suggest, however, that although organizations adapted well to remote operating models, many did not provide adequate communication and support. A study by Marsh McLennan among 256 employees, for example, found that one-third gave mixed reports of their manager’s preparedness and effectiveness in implementing company-wide response to the pandemic.

In another cross-industry study conducted among 5,043 full-time employees, high levels of anxiety were observed among personnel whose organizations did not clearly state their plans, policies and vision for remote work. The study, conducted by McKinsey & Company, also found that most employees would like to see their organizations adopt flexible and/or hybrid virtual working models after the pandemic has ended. More than 50% of participants in the survey would like to work from home at least three days per week in the future; those with young children are more likely to prefer fully remote working models.

Tufts Center for the Study of Drug Development collaborated with the Bill and Melinda Gates Medical Research Institute (Gates MRI) and undertook a global study in early 2021 to understand the attitudes, experiences and effectiveness of remote teams specifically within the clinical research enterprise. This study afforded the opportunity to gather more granular data and more targeted insights.

Tufts CSDD and Gates MRI teams established a working group of organizations comprised of stakeholders across the clinical research enterprise in order to solicit comprehensive and diverse input. A total of 26 organizations participated in this working group including representatives from patient advocacy groups, medical research foundations, academic medical centers, government agencies, pharmaceutical and biotechnology companies, contract research organizations and investigative sites.

Based on a working group discussion, a 69-question online survey was developed. In addition to questions assessing detailed respondent characteristics (e.g., demographics, organizational characteristics), the survey focused on specific steps taken to adopt remote work practices before and since the pandemic began, organizational support in the transition to remote work, employee wellness, capacity for work, diversity and inclusion, and the impact of remote approaches to work. Respondents were also asked about their perceptions surrounding clinical trial performance and the future of remote work.

Survey responses were fielded globally between January 27, 2021 and April 9, 2021. A total of 344

 unique responses were gathered and reflected high survey response completeness and variation.

 The results of our analysis are presented below. 

We analyzed twelve different subgroups (see Exhibit 1) to understand personnel experiences adapting to and operating remotely.

Exhibit 1: Characteristics of Respondents

Our sample includes respondents from more than 50 countries across five continents, as well as a wide range of races and ethnicities. More than half of respondents live in the US & Canada and self-reported white, female, and between the ages of 35 and 54. Most respondents also indicated having caregiving responsibilities and one or more children. Nearly six-out-of-ten respondents reported that they are employed by large organizations.

The vast majority of those working at academic medical centers and research institutions reside in the US and Canada.

Whereas some significant differences were observed across all twelve subgroups, significant differences (p

.05) were most commonly observed by organization type and geographic area.

Approximately four-out-of-ten (43%) respondents indicated that their productivity was unchanged since the pandemic began, while 35% reported that their productivity had increased. A lower proportion—19%—noted that their output had declined and 3% were not sure. Respondents working in pharmaceutical and biotechnology organizations were more likely to report higher productivity than respondents working in other types of organizations (p 

.05). US and Canadian respondents were more apt to report higher productivity levels since the pandemic began compared to European, UK, and Latin American respondents. Differences by respondent age were also observed; those between 35 and 54 reported higher productivity compared to respondents in younger or older groups (p 

Respondents’ self-reported assessments of their remote performance was high: 71% indicated ‘very effective’ and 26% ‘somewhat effective’. Similarly, more than three-fourths of remote team managers evaluated their teams as being ‘very productive’ (76%) and one-fifth (21%) as ‘somewhat productive’ since the pandemic began, reflecting alignment between the perceptions of team managers and individual team members (see Exhibit 2).

Exhibit 2: Self-reported remote performance vs. team productivity rating

Respondents from biopharmaceutical companies and contract research organizations (CRO) were more prone to report that they were either ‘very’ or ‘somewhat effective’ in their remote roles compared to those working at academic medical centers or research institutions (p

 .05). In addition, those without children tended to report that they were more effective (‘somewhat’ or ‘very’) doing remote work compared to those having one or more children. In comparing women and men, women had an increased likelihood of reporting that they were ‘very’ or ‘somewhat effective’ performing remotely compared to men (p 

The vast majority (93%) of respondents indicated they were satisfied with their organization’s preparedness in transitioning to remote work, 95% reported satisfaction with their organization’s responsiveness, and 57% reported satisfaction with provision of resources by their organization. European and UK respondents were more likely to report satisfaction with their organization’s preparedness and responsiveness (p

.05). In contrast, Latin American respondents were less likely to report satisfaction with provision of resources compared to those in other geographies. Individuals working at biopharmaceutical organizations were also more likely to report satisfaction with preparedness, responsiveness, and provision of resources when compared to other types of organizations (p 

Three-out-of-four (74%) respondents indicated that their organizations had a remote work policy in place prior to the pandemic and 66% reported that their remote work policies changed once the pandemic began. Some of the changes reported include financial support for better home office setups, allowance for relocation “beyond reasonable commute” areas, increased number of virtual meetings, and greater flexibility. In addition, respondents also reported increased quality and scope of information technology (IT) support, expansion of the existing remote policy to include roles that were previously not included, and a shift to permanently remote setups, among other changes.

A higher proportion of CRO respondents worked at organizations that had a remote work policy in place before the pandemic began. Biopharmaceutical respondents were more likely to say their remote work policy changed during the pandemic compared to other types of organizations (p 

A higher percentage of US and Canadian respondents reported that their remote work policy had changed since February of 2020 compared to respondents located in other geographies (p 

.05). Most respondents also reported that their respective organizations provided access to the basic elements of remote work such as laptops/desktops (89%), paid access to communications platforms (88%), and stable compensation (85%).

Notable differences were observed in levels of provision of resources by organization type, with pharmaceutical and biotechnology companies and CROs providing most resources to their staff at higher levels. Respondents from biopharmaceutical companies were more likely to report access to computer monitors and hardware such as mouses, keyboards, and headphones when compared to other types of institutions (i.e., non-profits, etc.) (p <.05). We found that a higher percentage of CRO respondents reported receiving paid access to high-speed internet compared to other types of organizations (p <.05). We also observed that higher proportions of respondents from academic medical centers, research institutions, and pharma/biotech companies reported access to updated standard operating procedures (SOPs) and regulatory compliance training during the pandemic.

Interestingly, significant differences were not observed in the importance rating given by respondents to each of the resources we enquired about. Most respondents agreed that paid access to high-speed internet and virtual communication platforms were highly important to the effectiveness of remote work, and yet these resources were not provided at similar levels across the various types of organizations included in this study.

Overall satisfaction with organizational approaches to remote work was very positive; 92% of respondents indicated they were ‘very’ or ‘somewhat’ satisfied with the approach implemented by their organization (see Exhibit 3). Respondents expressed satisfaction with their organization’s approach to cybersecurity (94%) and access to communication platforms (90%).

Exhibit 3: Satisfaction with organization’s approach to remote work since February 2020

Female respondents were more likely to be satisfied (95%) with their organization’s approach compared to males (90%). Biopharmaceutical companies and CROs were also more satisfied than were other types of organizations. These results were statistically significant (p 

Impact of remote work: burnout, inclusion, and social support

The Tufts CSDD/Gates MRI global survey also detected adverse effects of remote team activity. More than half (55%) of respondents reported feeling burnt out, while 9% of respondents said they were unsure. Burnout was primarily attributed to factors such as frequency of virtual meetings, added work responsibilities, restlessness, and uncertainty in work demands. The latter factor is consistent with findings reported in other recent studies.

Other factors contributing to burnout include feelings of loneliness and hopelessness, caretaking difficulties, and inadequate access to tools. Many respondents also reported facing emotional burden due to the US political environment in 2020, deterioration of co-worker relationships, and the inability to travel.

Respondents aged 18-34 were more likely to report burnout compared to those 35 and older (p 

.05). Female respondents were also more likely to report burnout compared to males—at 57% and 51% respectively (p value 

.05) A striking number of respondents within academic medical centers and research institutions—71%—said they have felt burnout since February 2020. This proportion is nearly 1.5x higher compared to respondents in biopharmaceutical companies, CROs, medical research foundations, patient groups, and government agencies. Not surprisingly, respondents who were in roles with frequent patient interaction were more likely to report feelings of burnout (61%) compared to those in roles without patient interaction (54%).

Among the 18-34 age group and those with caregiving responsibilities, the factors causing higher relative reported burnout included frequency of work-related meetings, added work-related responsibilities, uncertainty and variability in work-related demands, and feelings of hopelessness (see Exhibit 5).

Respondents in Latin America were almost 4x more likely to say that feelings of hopelessness were a major or moderate factor in their feeling burned-out compared to respondents in other geographies. Rest of world (ROW)—Asia, Australia, Africa—respondents were more inclined to report frequency of work-related meetings as a major or moderate factor in their burnout.

Exhibit 5: Differences in reported causes of burnout across age groups, geography, and whether they were caregivers

A high majority (82%) of clinical research professionals indicated that their feelings of connection to their colleagues had deteriorated since February 2020, with four out of ten saying they felt less connected to their colleagues. Loss of connection with colleagues was most observed among those in patient-facing roles (55%). Interestingly, 87% of survey participants said they felt somewhat or very supported by their colleagues, while 86% indicated they felt supported by their managers and leadership. Those working at pharmaceutical and biotechnology organizations were more likely to say they felt supported by colleagues, managers, and leadership, compared to those employed by academic medical centers and research institutions (p <.05); 90% of respondents from biopharmaceutical companies reported feeling supported compared to 82% at academic medical centers and research institutions.

Eight-in-ten (80%) respondents reported that the greatest benefit of remote work and collaboration was increased flexibility followed by gained time from not having to travel or commute to work (12%). Better relative participation within and across teams was also a key benefit mentioned.

The vast majority of respondents (89%) felt that they were either ‘extremely’ or ‘somewhat’ likely to embrace adopting a mostly remote work model, and a similar percentage of respondents (84%) indicated a high probability that their organization’s leadership would accept continued remote work models (see Exhibit 6).

A mostly remote work model was defined as having 60% of staff working remotely at least 60% of the time. Females were more apt than males to support this model and US and Canadians were more prone to accept working primarily remotely compared to their European, UK, and ROW counterparts (p 

Exhibit 6: Likelihood of management to permanently embrace a ‘mostly-remote’ work model

Most respondents (86%) indicated support for their organization’s current remote model—or a similar version—to continue when the pandemic ends. Respondents over the age of 35 compared to other age groups; and females with one or more children at home were the most likely to support their organization’s current remote model after the pandemic ends (p 

Those in the US, Canada, and Latin America indicated support for their company’s remote work model compared to European, UK and ROW (Asia, Australia, Africa) respondents (p 

 .05). And pharmaceutical and biotechnology company representatives expressed a higher likelihood to want to continue in their organization’s current remote work model compared to those working in other organizational settings (p 

The results of the Tufts CSDD/Gates MRI Remote Clinical Research Team Experience and Effectiveness study indicate that clinical teams have transitioned to remote collaboration models well facilitated by employers who are generally supportive and prepared. Remote clinical teams report performing their roles effectively, but a high percentage are feeling burned out and experiencing deterioration in their connections with their colleagues. 

Gaps were identified in respondents’ perceived importance of resources in select areas compared to organizations’ provision of these. Wide gaps were especially seen in the perceived importance of high-speed internet access and external computer monitors compared to their provision, suggesting that additional investment may be required by certain organizations in select areas to sustain their remote work activity.

Biopharmaceutical company and CRO respondents reported a greater likelihood of perceived effectiveness in their remote roles compared to those working at academic medical centers or research institutions. This result may also be tied to (1) differences in investment in resources at other types of organizations, and (2) that academic medical centers and research institutions may require greater support from sponsors and other stakeholders to conduct clinical research effectively using remote approaches.

Global differences also were observed in self-reported productivity; respondents in the EU, UK, and Latin America reported lower levels compared to their counterparts in the US and Canada. This finding suggests that there may be geographic disparities in the level of remote support provided. Further study is needed to examine this area. 

Substantial burnout was observed globally with the primary causes identified as frequency of virtual meetings, added work-related responsibilities, variability and uncertainty and feelings of restlessness. Younger workers, women, and respondents from academic medical centers and research institutions were more likely to report burnout. Retaining younger workers could become a greater issue as the pandemic ends with those workers leaving for organizations that return to the workplace or offer more opportunities to interact and collaborate face-to-face with co-workers. In addition, workers who were younger than 35 were also less likely to endorse a remote model in the future. Women, however, were more likely than men to support a future remote model, suggesting that more support might need to be established for women who continue to work remotely to avoid experiencing burnout. More effective and less frequent virtual communication may help address burnout while improving connectivity among workers.

Despite some of the subgroup differences, the vast majority of respondents support a version of their organization’s remote model when the pandemic ends. This finding underscores the importance of establishing operating models that can accommodate a variety of options simultaneously for employees who prefer to continue to work from home and those who prefer a mix of home—and office—based activity, especially younger workers and women. Offering flexibility to those who have responsibilities outside of work is critical and has been characterized in other studies.

The Tufts CSDD/Gates MRI study focused on the impact of remote clinical team collaboration experience at the beginning and in the earlier stages of the pandemic. We will continue to examine and draw lessons and insights on remote team experience and effectiveness long after the pandemic is behind us. As organizations adjust and adopt policies to accommodate and support a global remote and hybrid workforce, newer models and opportunities to drive innovation and employee satisfaction will no doubt emerge.

, MBA, is Deputy Director and Research Professor; all of Tufts Center for the Study of Drug Development, Tufts University School of Medicine.

Alexander, De Smet, Langstaff, Ravid. What employees are saying about the future of remote work. McKinsey and Company Report. April 1, 2021. 

Cleveland Clinic’s Cancer Research Team Sees Increased Productivity During COVID-19. Cleveland Clinic. December 7, 2020. 

Jenkins, Zabor, Mooney, et al. Increased Productivity and Efficiency Among Cancer Center Clinical Trials Workforce during the COVID-19 Pandemic. 

LeBreton, Lamberti, Dion, et al. COVID-119 and Its Impact on the Future of Clinical Trial Execution. Applied Clinical Trials, October 22, 2020. 

Caputo, Hyland. Employee Concerns about COVID-19. Marsh McLennan Report. 2021. 

344 surveys were submitted with fully signed and completed consent forms.

For nearly every question, approximately 15 respondents chose not to answer.

A summary of how organizations approached remote operating models and the experiences and effectiveness of clinical research professionals in their roles and responsibilities during the COVID-19 pandemic.

Remote Clinical Research Team Experience and Effectiveness During the COVID-19 Pandemic

The COVID-19 pandemic caused major disruptions to clinical trial execution in the U.S., impacting key stakeholders across the industry. Investigative site capabilities experienced upheaval, driven by staff furloughs, social-distancing protocols, financial losses, and concerns over patient safety. Sponsors, CROs and other organizations that support drug development shifted to remote working environments. An estimated 80% of non-COVID-19 trials were stopped or interrupted as a result of the COVID-19 pandemic.

An April 2020 study suggests investigative sites demonstrated flexibility and ingenuity in adopting new approaches in order to cope with challenges presented by COVID, with over half of investigative sites transitioning to virtual approaches to interact with patients. More recently, follow-up studies performed in August 2020 have identified persistent impact of COVID, with over 60% reporting an “average” or greater level of impact on ongoing trials and initiation of new trials. Respondents specifically highlighted challenges in patient enrollment and recruitment.

Recent FDA guidance (March 2020 and updated July 2020)

acknowledged that the impact of COVID-19 may require companies conducting clinical trials to consider virtual patient visits or put new processes in place regarding their current protocols. Therefore, there are now more opportunities for using remote healthcare including conducting virtual or decentralized trials, site-less clinical trials and use of other non-traditional approaches that do not involve in-person visits. This shift, driven by the effects of the pandemic, prompted the team at the Tufts Center for the Study of Drug Development to conduct a qualitative study researching the impact of COVID-19 on clinical trial execution. 

The study examined the effects of COVID-19 on clinical trials by gathering insights and perceptions from clinical operations professionals at pharmaceutical companies in the United States. The goal was to understand the modifications that organizations have made in response to the pandemic, especially with regard to remote or virtual approaches. In addition, the study explored how companies have approached planning and implementing remote and virtual approaches to trials, as well as their experience and lessons learned. Last, Tufts researchers sought to understand initial perspectives on how COVID-19 will impact trial execution in the long-term.

A total of 25 interviews with pharmaceutical and biotechnology executives within the clinical operations department from unique companies were conducted using Zoom. All executives worked in the United States and played a role in U.S. clinical operations. Participants were selected from Tufts CSDD proprietary lists of contacts who work in clinical roles and through other collaborations on prior studies or from professional conferences and meetings. Participants were recruited via email from June to early August and have extensive experience conducting clinical trials across diverse therapeutic areas. Interviews were 30 minutes in duration and were conducted by Tufts CSDD researchers using a comprehensive discussion guide encompassing the following areas: (1) COVID-19 Impact on Ongoing Trials, (2) Organizational Preparedness, (3) Trial Amendments and Remote Technologies, (4) Role of Regulatory Agencies (5) Role of Third-Parties, (6) Long-term Impact of COVID-19.

Interviews were conducted with U.S.-based staff at 25 organizations comprised of pharmaceutical, biotechnology, and non-profit research institutions. There were 15 large organizations represented and 8 mid-sized or small companies based on R&D spending.* Two were non-profit organizations. These were included given they often sponsor government-funded clinical research.

Eleven organizations halted ongoing trials and enrollment for at least one month. Shutdowns were most frequently driven by concerns that patients would not be able to safely travel to and receive care at research centers. These concerns were especially poignant in indications that were considered “high-risk” for COVID infection (e.g., cardiology, pulmonology, immunology) or indications where patients had difficulty traveling or for example, had neuromuscular and/or neurodegenerative conditions. In these cases, studies often resumed only once patient safety was assured and R&D organizations had amended protocols to include suitable pandemic contingency plans. An interviewee discussed the impact of COVID on their ongoing trials:

“We put our entire portfolio on hold for two months—it became clear we were not ready to move to a virtual situation.”

Another 12 organizations reported moderate impacts on ongoing trials, most frequently citing delayed enrollment as the primary challenge related to COVID. Several factors may have reduced impact on ongoing trials. Trials in indications such as dermatology and psychiatry may have faced less severe disruption, given more frequent use of telehealth in clinical practice prior to COVID or relative ease of transitioning collection of outcome measures to remote methods (e.g., measuring skin lesion size over telehealth). Additionally, organizations that demonstrated a higher level of pre-COVID preparedness or greater organizational agility tended to report lower impact. Finally, organizations with modest impact often reported partial, geographically isolated closures or understaffing at select sites, rather than full shutdowns reported by those experiencing greater impact. The impact on an organization’s investigative sites is described by a respondent: 

“Many of our sites were partially closed, and we had to incur additional cost to sustain our study. We are maybe approximately 25% behind on enrollment as a result.”

Most R&D organizations that reported some level of COVID impact suggested that the ability of sites to respond to the pandemic was a key indicator of the level of impact. Given COVID-19 outbreaks occurred regionally in the U.S., differences in site response emerged based on location and time period. Respondents identified four key factors that tended to influence sites’ abilities to respond to the pandemic. First, staffing furloughs were often site-dependent, and often resulted in delays in data processing, as well as scheduling and execution of patient visits. Additionally, many patients felt hesitant to visit research centers, especially in harder-hit regions, with select organizations citing higher rates of patient withdrawal from studies. Sites with poor or non-compliant IT faced significant challenges pivoting to telehealth visits, providing access to EMR to investigators, or completing CRA site visits virtually. Finally, sites set different restrictions based on hospital- and state-imposed protocols (e.g., no lab-only visits, additional PPE needed, etc.) that resulted in potential deviations from protocol or delays.

Figure 1. 23 of 25 organizations reported some level of impact on ongoing trials due to COVID-19.

A couple of organizations (n = 2) reported experiencing small or no disruptions. These organizations were often running early stage trials (e.g., Phase I) where clinical follow-ups to identify adverse events could easily be performed over telehealth. An interviewee conducting studies in early phases noted that “there is a fairly large dichotomy between early phase and late phase—the impact for Phase I and Phase II is a little less.” Organizations with less disruptions also were often running trials in disease areas where patients required urgent treatment and/or had few options for treatment (e.g., oncology, rare disease).

Organization response: successes and failures

R&D organizations reported a spectrum of success in responding to the challenges presented by COVID. R&D organizations that self-reported “successful” responses to COVID-19 often demonstrated at least one of four key success factors: organizational agility, prior investment in remote technologies, development of COVID-19 task forces, and/or strong R&D capabilities in Asia-Pacific (APAC) regions.

Five organizations cited organizational agility as a key factor in the success of their COVID response. Smaller, flatter organizations were less hindered by bureaucracy, and were able to rapidly implement changes to studies.Decisions were made at a study-team level and upper management were informed of decision-making. In these cases, it was critical that leadership trusted their employees to execute trial changes without significant oversight.

Another 5 companies were piloting remote technologies and services prior to COVID and reported transitioning more easily to “virtual” trials.Several organizations were piloting telehealth, remote data monitoring, home health, and other virtual approaches in ongoing studies. Comfort with existing remote infrastructure allowed for rapid expansion into indications that did not initially leverage but could benefit from virtual approaches (e.g., measurement of skin lesions over telehealth in dermatology trials). The trend of shifting to a more remote model was explained by an interviewee:

“We were already in the process of things becoming more virtual anyway. This has definitely accelerated the process because we’ve had to adapt.

We are thinking more about how we collect data, verify data from a remote perspective.”

Establishment of a task force was instrumental for larger companies to prepare and rapidly amend trial designs to include remote modalities, with 5 of interviewed organizations reporting implementing such task forces. For larger organizations, the creation of response teams was critical to preparing for COVID’s impact. Organizations that successfully adapted trials to COVID-19 typically had upper leadership that trusted their task force to execute without significant oversight. In select cases, leadership indicated desire to press forward with additional changes to future trials, in order to continue building upon the trend toward virtual trials. The COVID-19 task force typically encompassed representatives from all key trial functions. Experienced team members with backgrounds in operations, regulatory, and data management were all required for implementation of novel remote technologies. Following general guidelines from the COVID-19 task force, study leads often were responsible for managing direct COVID-19 impact. Study leads needed to consider each investigative site separately, given variable COVID-19 activity across regions in the U.S. Task forces that took a study-by-study and site-by-site approach reported greater success than those that attempted a “uniform” approach. The importance of a relatively independent task force that could communicate with study teams and leadership was explained by two interviewees:

“There wasn’t a one-size-fits-all approach to our trials, given they were in different therapeutic areas and geographic regions. Thus, it was important to allow study teams to make recommendations that we could then adopt.”

“Communication with leadership was important to keep them informed of changes to our trials. They really just let us run with it. Now that we have a plan, leadership is pushing to make ‘the next step’ and make sure we COVID-proof our trials going forward. This includes leveraging more virtual approaches.”

A minority of organizations (~2) reported leveraging their organizations’ R&D capabilities in China and Japan, who had early COVID experience, to prepare ongoing studies in the U.S. Select global R&D programs indicated that their colleagues in China and Japan warned them about the impact COVID may have on trial execution, which allowed them to prepare for COVID and begin to develop protocols in case sites were shut down. Of note, this was a benefit that was not reported consistently by global R&D organizations and may be dependent on specific colleague-colleague relationships.

Adoption of remote monitoring technologies and decentralized approaches

Interviewed stakeholders implemented a wide range of novel remote monitoring technologies and decentralized approaches to make trials more patient-centric in the COVID era.

Figure 2. Telemedicine and eConsent were the most frequently utilized remote technologies, while home health was the most frequently utilized remote service.

Telemedicine and eConsent were the most frequently mentioned technologies adopted during COVID-19. Telemedicine was implemented by the majority of respondents, with 19 interviewed organizations reporting use of telehealth in ongoing trials. Telemedicine was most frequently used for routine follow-ups to identify adverse events, especially in Phase I studies. Telehealth was also used to measure select objective outcome measures (e.g., lesion size in dermatology or plaque psoriasis). Though investigators recognized the potential to collect other measures via telehealth (e.g., depression scales), they expressed concern that the method is not validated and requires proof of concept before regulators would accept data generated through telehealth. eConsent was used by 10 companies and was perceived to be one of the simplest innovations to implement. Respondents highlighted the potential for eConsent to facilitate communication with patients, by leveraging novel modalities such as video explanations, quizzes to assess understanding, etc. Interviewees offered their insights on remote technologies:

“I expect eConsent and telemedicine will become routine and integral parts of clinical trials. They are pretty straightforward steps towards a more patient-centric trial, and could easily be adopted in most, if not all, protocols.”

“We had piloted eConsent on a couple of studies and it (COVID) moved us out of the pilot very quickly. We’re trying telemedicine even more. How do we ‘hybridize’ a trial even outside of COVID to reduce patient burden?

Broader use of telemedicine may encourage enrollment and make trials more patient-centric.”

ePRO was the next most frequently utilized technology, with eight companies citing use. Notably, ePRO was already used in ongoing trials prior to COVID. However, in an effort to further reduce patient burden, research organizations opted to allow patients to use their own devices.

Use of data integration was perceived to be highly useful to R&D organizations, given R&D organizations could access trial data in real-time. Additionally, utilization of EMR provided opportunities for R&D organizations to supplement clinical research data, as potential alternatives to monitor adverse event and clinical care patterns. However, only select companies (n = 4) actually leveraged real-time integration of trial data or EMR during COVID. Several respondents cited challenges with implementation of integrated EMR, given poor investigative site IT infrastructure, investigative site preferences, or challenges with CRO staffing or capability to visit sites. Privacy restrictions, interoperability and compatibility challenges represent additional key barriers to utilization of these technologies. One interviewee discussed the barriers that have emerged in monitoring due to COVID:

“Monitoring is our biggest challenge right now and we’re trying to get back out to sites. Across the board we have major Phase III database locks and we cannot get to some of the final sites that have data. If we don’t have access to their EMR is there another way? We are discussing remote approaches and technologies that can be implemented.”

A number of respondents expressed interest in the future use of integrated EMR, and suggested they were actively seeking CRO partners to implement the technology once sites reopened. In addition to novel technologies, respondents adopted a range of approaches to decentralize trials and minimize patient exposure to investigative sites in the face of COVID-19. Overall, nearly half of respondents implemented at least one approach to decentralize ongoing trials.

Approximately seven organizations implemented some method of home health in their ongoing trials to ensure patients that were unable or unwilling to travel received IV medications and were able to provide blood samples. Rare disease trials reported greater use of home health, given the long distances patients may have to travel to access the investigative site and the need for frequent IV infusions. However, investigators also noted that home health was “hit-or-miss,” given some patients resided in locations inaccessible to home health while others refused to allow nurses in their home due to concerns with the spread of COVID-19. “Home care and direct-to-patient drug delivery are steps to move towards a more patient-centric trial design,” commented one interviewee. Direct-to-patient drug delivery was implemented by five companies and perceived to be a relatively low-risk method to transition trials to be more patient-centric, especially for oral agents with safer expected toxicity profiles.

Findings from a Tufts study examining the effects of COVID-19 on clinical trials.

Mary Jo Lamberti, PhD

Articles

The Impact of Decentralized and Hybrid Trials on Sponsor and CRO Collaborations

Assessing Sponsor and CRO Awareness

Remote Clinical Research Team Experience and Effectiveness During the COVID-19 Pandemic

COVID-19 and Its Impact on the Future of Clinical Trial Execution

Understanding the Complexities of Diversifying Clinical Trials

New Benchmarks for Trial Initiation Activities