Beth Harper 

During the past several years, in the wake of the COVID-19 pandemic, investigative sites have faced unprecedented challenges executing clinical trials. In additon to administering more complex protocols, finding patients under more stringent eligibility criteria, and retaining patients under more onerous participation requirements, sites have had to accommodate the use of a variety of remote and virtual technologies to collect and manage clinical trial data. At the same time, chronic operating challenges including inadequate study budgets, protracted contract negotiations, punitive hold-back payments, and poor CRA quality and continuity have continued to plague investigative sites. And recently, investigative sites have encountered higher levels of staff turnover and shortages.

The Tufts Center for the Study of Drug Development (Tufts CSDD) recently conducted a survey to understand the current mindset, experience and outlook of a global community of investigative sites. The survey endeavored to garner the perspectives of the “typical” investigative site and to understand variation in perspectives and experience by site type and by personnel function.*

This article presents highlights of the survey results and offers insights into ways that sponsors and CROs can strengthen their relationships with sites in this current, post-pandemic clinical trial operating environment.

Survey methodology and data characteristics

The survey was conducted online between October and December 2022. To reach a global community of investigative sites, Tufts CSDD used proprietary contact lists and partnered with the Association of Clincial Research Professionals. A total of 205 responses were collected.

The majority of respondents are employed by integrated clinical care/research sites (81%), and the remaining (19%) are employed by dedicated sites/site networks. 64% of respondents held a clinical site staff role and 36% held an administrative role. Clinical staff included roles such as PIs or Sub-Is, Clinical Research Coordinator (CRCs), and Clinical Research Nurses (CRNs) whereas administrative staff included site directors, research managers or equivalent roles.

Overall,respondents were experienced with a mean tenure in clinical research of 17 years with a range of less than one year up to 50 years working in the industry.

While the majority (70%) of respondents is employed in North America/Central America, 16% are employed in Europe, 10% in Asia (10%) and 4% in other regions of the world (Table 1). 

In general, the majority of respondents reports that many study start-up, execution and other operating activities have worsened substantially over the last 5 years (Table 2). Some of these challenges are related to the COVID-19 pandemic whereas others are long-standing issues.

Hiring and retaining staff topped the keylist of primary challenges with budgets and contracts as well as study initiative activities a close second and third. Interestingly only 42% of respondents feel that implementing new technology had worsened somewhat or greatly. These findings are in contrast to some other recent site surveys where technology-related factors appear to have a bigger impact on site operations.

No significant differences are observed by site type, although it is noteworthy that only 20% of respondents from dedicated sites/site networks feel that interacting with sponsors had worsened compared to 35% of respondents from sites where research is integrated with clinical care. Administrative staff hae more positive views about sponsor interactions than do clinical staff.This could perhaps be a result of the investments sponsors have made engaging sites through professional research sites through various industry collaborations such as through SCRS, ACRP, TransCelerate, and the type of site staff who participate in these initiatives.

Perceived change in site operating activities during the past five years by site type and role

Unsurprisingly, site staff who feel that things have worsened substantially over the last 5 years have a more pessimistic view of the future outlook of clinical research at their site in the next five years. Conversely, site staff who feel these operating activities have not worsened greatly or somewhat over the last 5 years, have a more optimistic viewpoint.

Site optimism and factors driving the optimism

The results also reveal that nearly 80% of respondents hae a ‘Somewhat’ or ‘Very Optimistic’ view of the future (Table 3).

Optimism* for the future overall and by site type and respondent role

*Question: My outlook for the future of clinical research at my investigative site over the next five years

No significant differences are observed by site type or role although administrative staff reports being very optimistic in somewhat higher proportion compared to the clinical staff. One interesting finding is that site staff with less tenure have a more positive outlook than more experienced staff although the differences are not statistically significant (Figure 1). This may be explained by the fact that less experienced staff have a limited baseline on which to compare trends. Similarly, more seasoned veterans may have become more jaded in their attitudes or are more frustrated with the lack of progress in some areas.

Viewpoints based on tenure of clinical research experience

The most astonishing finding however, was the degree to which sponsor-site relationships affect positive or negative perceptions; specifically the degree to which sponsors seek, value, and apply site feedback is significantly related to site optimism about the future. Higher percentages of respondents who agree that sponsors seek (87%), value (86%), and applied (87%) site feedback are optimistic about the future (Table 4).

Relationship between site optimism and perceived degree that sponsors seek, value and apply site feedback

Those that felt that sponsors they work with value input even if they are unable to apply it are over 4 times more likely to be optimistic about the future. Similarly, those that perceive that the sponsor applies site feedback and those that feel the sponsor seeks out site feedback are over 3 times more likely to be optimistic about the future. Several respondents underscored this point, noting that:

“Soliciting and implementing changes based on the feedback of experienced sites would help sites succeed in implementing study protocols and likely would prevent many failed trials.”

“Sponsors who do not ask for feedback from study coordinators regarding study design and feasibility generally have poorly designed, non-feasible studies. Sponsors should seek consultation from study coordinators, as we are the ‘boots on the ground’ and can tell a sponsor if something does not appear to be doable or will be too much burden on participants and/or study staff.”

—Clinical research coordinator/site director

Even if site feedback cannot be incorporated, respondents value hearing from sponsors that their feedback was considered.

Patient centricity and site centricity are one and the same

Overall sites feelthat more traditional patient-centric services such as pre-paid debit cards and transportation assistance programs have a much greater impact on a volunteer’s willingness to participate in clinical trials than some of the newer approaches (Figure 2). Over half of the respondents feelthese had a greater influence compared to remote visits, home-health services or local pharmacy-based visits.

Solutions that greatly enhance volunteer participation

Nonetheless, respondents feelthat overall, any of the DCT-related solutions aimed at enhancing volunteer participation also enhance site implementation success (Figure 3). These findings suggest that if the site perceives a solution will enable their success and if they are bought-into the solution, then it may translate into enhanced volunteer participation. Or, at a minimum, a perceived positive influence on participation rates.

Perceptions of impact of DCT-related solutions on participation and site implementtion

One industry expert noted that “the most patient-centric thing sponsors can do is to be site-centric.” The results of the Tufts CSDD survey support that observation.

Supporting healthy sponsor-site relationships by tackling age-old issues

Nearly every industry survey on site perceptions reinforces the importance of addressing the enduring challenges of study budgets, CRA quality and study complexity.

 The results of this study were no exception (Figure 4).

Top factors that greatly enhance site sustainability

When asked which factors would greatly enhance the site’s likelihood of remaining in business going forward, the number one factor, reported by two-thirds of the respondents, is ensuring that study budgets reflect the true work efforts of the site. This is likely related to the intensity and complexity of the study as well with nearly half of the respondents suggesting that reduced intensity could facilitate better study implementation and future site viability. As one respondent noted:

“The resources to implement procedure-intensive studies are just so limited it would be great to have sponsors think carefully about what matters in getting the drug approved.”

Similarly, over half of the sites also reinforce the qualifications of the CRAs/monitors as having a great influence on the viability of clinical research operations in the future. This was reinforced by another respondent who commented:

“If we were able to significantly increase the number of competent monitors for clinical trials, I think a large number of the issues that we face would dissipate.”

There were some significate differences noted between clinical and administrative staff for each of these factors with administrative staff ranking all of these factors as having a greater influence than the clinical staff. This speaks to importance of tailoring site interactions to address the needs of the different roles.

While these themes were reinforced through a vast number of qualitative responses, one site director summed it up most succinctly:

It stands to reason that sites who feel respected and heard by sponsors will have a more optimistic view of the future. What may be less intuitive however, is the importance of pairing investments in new technologies with investments in behaviors that foster relationship quality with site staff, particularly more seasoned veterans. Simply focusing on novel approaches to conducting trials or implementing new technologies will only go so far in terms of becoming the sponsor of choice or accelerating clinical trials. Site staff who feel heard and that their experiences are valued, may withstand any number of burdensome procedures, novel technologies and procedure-intensive studies.

The results of this survey suggest that it may be less about the complexity of the study design, implementation model, or use of a given technology and more about the relationship the sponsor has with the site (in general) and specific roles at the site (administrative versus clinical staff).In addition, focusing on persistent challenges related to the adequacy of study budgets and CRA quality may have a greater impact on both the quality of the site relationship, as well as study performance.

In upcoming research, we hope to further explore the extent to which the qualitative aspects of sponsor-site relationships impact site performance and the adoption of new solutions supporting clinical trial execution.

*For this study, Tufts CSDD differentiated two site types: one that integrates research activities withing clinical care settings including not-for-profit clinics, hospitals, health systems, academic and government-affiliated hospitalsystems, and for-profit clinics and hospitals that provide clinical care and also conduct clinical research studies; and the other that conducts clinical trials within a dedicated site(s) / site networks and that derives the majority of their income from industry-funded clinical trial study grants.

We would like to acknowledge the following individuals who provided input into the survey design or shared their insights on the results:

Jessica Fritter; associate faculty, clinical instructor of practice, The Ohio State University College of Nursing, and partner, BJE Consultants

Victoria DiBiaso; global head, patient informed development & health value translation, Sanofi

Joseph Kim; chief strategy officer, ProofPilot

Therica Miller; executive director, enterprise cancer clinical research, Tisch Cancer Institute at Mount Sinai

We would also like to acknowledge the Association of Clinical Research Professionals (ACRP) for distributing the survey to their members.

Scott, J. Sites Name Tech Acceptance as Essential Factor in Selection of Sponsors, Survey Finds. CenterWatch. 2018. Published online: January 16, 2023.

AVOCA, ACRP. Becoming a Sponsor or CRO of Choice – A Site Perspective. White paper published online: September 2018.

SCRS. Site Perspectives on Decentralized Clinical Trials. White paper published online: 2022.

Articles

Tufts CSDD survey finds fostering healthy relationships with site staff is key to a positive outlook.

Assessing Investigative Site Outlook and Operating Experience Post-Pandemic

The acceleration of drug discovery and development has taken on even greater importance as we face a third year of the COVID-19 pandemic. The industry has responded by incorporating remote monitoring techniques and fast-tracking the use of hybrid and decentralized clinical trial (DCT) models, at a pace never seen before. To sustain the momentum on these and other innovations that support study execution, we have also seen the rise of the #NoGoingBack initiative which aims to ensure that the progress made doesn’t fade when the pandemic finally fades.*

Despite these short term achievements, it is still taking more than 20 years to reach industry-wide adoption of various technologies and innovations that could prove beneficial to clinical research operations. Interactive Voice Response Systems (IVRS) and Electronic Data Capture (EDC) solutions were introduced in the late 1980s and early 1990s but these are only now reaching wide adoption

 by sponsors and CROs. Electronic Patient Reported Outcomes (ePRO), Electronic Clinical Outcomes Assessment (eCOA), and eSource technologies, while introduced in the mid to late 1990s, have yet to achieve wide adoption.

 This pattern holds true for risk-based monitoring, digital health outcomes, and other innovative approaches and solutions. While these innovations offer great promise, their potential can’t be realized if it takes two decades or more for them to be fully embedded into the drug development process.

In a first attempt to understand the factors impacting technology adoption, a 2020 Tufts CSDD study revealed that financial and regulatory concerns topped the list.

 Lack of trust in the technology was also reported as an important factor in that study. Additionally, it also revealed that organizational culture and senior leadership’s approach presented significant challenges to the process of technology adoption.

To gain further insights into the barriers to and opportunities for accelerating innovation adoption at both the industry and company levels, the Tufts Center for the Study of Drug Development (Tufts CSDD) undertook additional research in 2021. The purpose of this research is to characterize the long term adoption experience of technologies and capabilities supporting clinical trial execution. This research takes a long term view, and since we have yet to see the permanence of the changes that are taking place during the Covid-19 pandemic, these changes were not the focus of this research.

The research comprised informational interviews and an online global survey of biopharmaceutical executives and clinical research operations personnel. The research was completed in collaboration with WCG Avoca and seventeen biopharmaceutical sponsors who formed the working group (WG) participating in the project.

This article will provide some high-level findings from the research with a focus on actionable steps that biopharmaceutical executives can take to foster and support the adoption of innovations within their companies, namely:

Instituting mandates for greater operational efficiency

Greater support, involvement and engagement by senior leadership throughout all stages of the innovation adoption process

Offering incentives and recognition—and eliminating penalties—to individuals who promote innovative behaviors, approaches, and technologies within the organization; and

Implementing better change management, planning, and communication activities early on, and throughout the process.

The Primary stages of innovation adoption

Two predominant models exist that provide context for how innovations are adopted. The first model is the Gartner Hype Cycle, developed by Fenn in 1995. The second model is known as the Innovation Diffusion Model, developed by Rogers in 1963.

The initiation stage involves identification of the need to try a different technology, process, system, or approach to optimize clinical trial execution. This is where organizations gauge the interest and start the initial planning for trying or testing out an innovation. This is followed by the evaluation phase, which typically involves pilot projects or other assessments of the potential innovation. Based on results from the evaluation phase, organizations typically go through a decision-making process to either abandon or move forward with enterprise-wide adoption of the innovation. This is finally followed by a series of communications and training activities in support of broad implementation of the innovation throughout the organization.

These models informed the development of an interview guide and global survey. Twenty interviews were conducted with various stakeholders from the working group’s member companies. The interviews provided insights into the stages and decision-making processes that sponsor organizations follow to identify and evaluate potential innovations in the clinical development process. The findings from the interviews then shaped the creation of a global survey. The survey was organized into four key stages of the innovation adoption process, namely, initiation, evaluation, adoption decision and full implementation (Figure 1).

Figure 1. The Biopharma Innovation Adoption Cycle

The survey was primarly structured according to this four-step process with questions aimed at further understanding the process of adoption for new processes, systems and/or technologies that are transformative in terms of how the industry designs, plans, executes and manages data supporting clinical trials. Specifically, respondents were asked to consider innovations that are still emerging and haven’t yet reached industry-wide adoption. Illustrative examples were provided for reference and included eSource, eConsent, Risk Based Monitoring (RBM), Digital Health Endpoints and AI capabilities.

The survey asked respondents to characterize the timeframes for going through the various stages, the functional groups involved in the process, the types of quantitative and qualitative information used to advance from one stage to the next along with key challenges and barriers associated with each stage. Broader questions related to perceptions about how companies fared in their innovation adoption approach compared to others, and about how respondents viewed their company across the innovation diffusion model—innovator to late adopter or laggard—were included. The survey also captured perceptions of how the pharmaceutical industry compared to other industries when it comes to speed of innovation. Finally, the survey focused on opportunities for accelerating the innovation adoption process.

A total of 552 responses were received from a global audience primarily representing pharmaceutical and biotechnology companies. Approximately six percent of the respondents were from CROs or other organizations; however, responses from these individuals were not included in the primary analyses. Just over half of the respondents (53.9%) worked across large sponsors with 28% working at mid-size companies and 18.1% at small biopharma.

Nearly half of responses (49.3%) were received from individuals whose company headquarters were in Europe. 38.8% and 12% of responses were received from respondents with company headquarters based in North America and Rest of World (ROW), respectively.

A variety of roles were also represented, including professionals from Clinical Operations (46%); Clinical Development (9%); Innovation Management (17%); Data Science & Data Management (10%); Information Technology (3%) and 15% from other roles. About half (51%) of respondents reported that they had some influence on the adoption decision making process, with 30% indicating they had little to no impact on the decisions. 19% of respondents indicated that they were key decision-makers when it comes to the process of pursuing, evaluating, or implementing innovations in their organizations. Finally, 14.5% of respondents were part of a centralized or dedicated innovation group whereas the majority (85.5%) worked outside of such an innovation group.

Over two-thirds (69%) of respondents indicated that the adoption process within their organization generally followed the four-step approach as outlined above (Figure 1). Where the process differed, respondents indicated that there was no formal process, or that certain steps were less defined or skipped altogether. Interestingly, some respondents from smaller companies reported having staff with experience at large companies where things were “overprocessed”, and have therefore made the decision to eliminate the process altogether. These companies intentionally decide to move straight into implementation, preferring to sort out issues along the way rather than formalizing the method and/or metrics by which they evaluate and implement an innovation.

Thus, responses reflect a broad crosssection of views and perspectives from which to learn more about how the biopharmaceutical industry approaches the innovation adoption process, what gets in the way and how organizations, and the industry more broadly, can accelerate new technologies and innovations.

The survey results revealed that within individual biopharmaceutical companies the average innovation adoption cycle for a given clinical operations innovation lasts about 6 years. The longest reported cycle lasted 10 years with the shortest lasting 1.5 years (Figure 2).

Figure 2. Average Duration of Stages in the Biopharma Company’s Innovation Adoption Cycle

Cycle times varied by company size. Small biopharma reported the fastest cycle times and mid-size companies reported the longest (Figure 3).In general, the time to complete each stage increased across the four stages with the initiation step being the shortest and the full implementation stage taking the longest. The high coefficient of variation (CV) suggests wide variation in the length of each stage of the innovation adoption cycle.

Figure 3. The Biopharmaceutical Innovation Adoption Cycle by Company Size

When it comes to the impetus to pursue or explore an innovation, the results suggest that the primary factors are (1) a new or updated regulatory guidance, (2) an operating objective to improve the speed of clinical development, or (3) a mandate from senior management to pursue an innovation (Figure 4). The support and advocacy of senior leadership along with regulatory compliance and approval considerations were also big drivers of the decision to progress to the next stages. Financial considerations were among the top three drivers during the evaluation, adoption decision, and full implementation stages. The presence of change management strategies played a key role in the decision to move forward with full implementation.

Figure 4. Key Factors Driving the Progression of Stages in the Innovation Adoption Process

When asked about barriers and challeges, study participants reported that the easiest stages to complete were the earlier stages of the process (initiation and evaluation) with the adoption decision and full implementation stages being the most challenging (Table 1).

Table 1. Perceived Difficulty of Stages in the Innovation Adoption Cycle

Some interesting themes emerged in the analysis of barriers to completing or advancing to the next stages of the innovation adoption process. Key themes include:

Specifically, employee turnover and lack of cross-functional alignment are key factors that play a role across most stages. The lack of senior management involvement and support was identified as a key barrier at the evaluation and full implementation stages.

The lack of regulatory clarity and need for legal review and approval of the given innovation were reported as barriers across all stages indicating that companies like to ensure legal and regulatory acceptability prior ot moving to the next stage.

Financial constraints were noted as barriers in the three later stages, but were not reported as an issue impacting the initial pursuit of a potential innovation. Interestingly, the misalignment of incentives was also noted as a key barrier through the three later stages as well. This comes in the form of lack of rewards or recognition for exploring and advancing new ideas and the perceived risks associated with not meeting deadlines or budgets.

During the evaluation and adoption decision stages, difficulties in comparing vendors and uncertainty about the viability of a given vendor factored more heavily into the process to advance to the next stage, compared to vendor related considerations in the initiation or full implementation stages.

The absence of change management strategies and planning were identified as important challenges at the beginning and end stages of the process.

Opportunities to accelerate adoption of innovations

Many of the challenges and barriers noted by study participants are actionable.While there is recognition that greater regulatory clarity would be helpful in accelerating the process, this is often outside the direct influence of senior leadership (but something that regulatory agencies could do to facilitate more rapid adoption of new innovations). Nonetheless, respondents identified many opportunities for improvement in areas related to personnel, finances and incentives, and operations.

Senior leadership’s presence and support throughout the process

The most striking finding is that visible senior management support and promotion of an innovation throughout all stages of the process can lead to its faster adoption. Repondents echoed the signifincance of senior leadership mandates—as well as their presence and engagement at all stages—in improving the speed of innovation adoption. These perceptions align well with the correlations observed between companies with shorter timelines and the presence of senior leadership at each stage of the adoption cycle. Those companies that had senior leadership involvement at all stages also showed shorter timelines compared to those without. The mandates and support of senior leadership, coupled with the establishment of operational objectives to improve the speed of clinical development, can lead to shorter adoption cycles.

It is important to note that active, visible involvement and encouragement by senior leadership is currently a key factor in the speed of innovation adoption because the decision-making power on matters that affect innovation adoption tends to reside exclusively with this select group. An alternative approach that has been looked at, particularly within larger organizations, and which warrants further investigation is one where this decision-making power—and the accountability that follows it—is adequately distributed among teams and individuals throughout the organization.iv This approach could offer companies the ability to adapt easily, and to quickly make decisions that directly impact the speed of innovation adoption.

In a similar vein, company leadership are encouraged to continue to develop a culture of innovation within their organizations and across industry. Our research showed that nearly half of the respondents (42%) indicated either high or moderate risk to their performance review when pursuing adoption of an innovation. Thus, leaders are encouraged to build incentives for participating in the innovation adoption process into individual performance reviews.Offering incentives and recognition for the pursuit of a new approach instead of only holding individuals accountable for adherence to study timelines and budgets tends to be correlated with higher satisfaction with the innovation adoption process within biopharmaceutical companies. Providing adequate funding, resources and financial incentives to these individuals so that they can explore, pilot, and drive the adoption process can lead to quicker innovation adoption timelines. Additionally, leaders should be mindful of inadvertently penalizing individuals who develop, champion, and/or try new ideas, approaches and technologies.

Another important element for the development of a culture of innovation is the presence of a change management strategy. Study participants reported that change management strategies and communication planning play significant roles in fostering faster adoption. Waiting for the full implementation stage to think through how the organization will use, integrate, and manage a given innovation may hamper its rapid adoption.

An important outcome of this research is that substantive differences in cycle times were not identified between companies that have a dedicated innovation group compared to those that don’t. Intuitively, the presence of a dedicated innovation group would lead to faster cycle times or fewer challenges in the later stages of the process; this hypothesis was not validated here, however. Interestingly, respondents from smaller biopharma companies suggested in high proportion that innovation groups could help accelerate the adoption process. These were also the same companies that reported the presence of innovation groups in the lowest proportions compared to mid-sized and large pharma, while reporting the fastest timelines. The faster timelines observed at smaller biopharma might be explained by their greater reliance on CRO partners, the smaller scales in which they work, and their high degree of specialization in one or few therapeutic areas, among other factors. This topic warrants further investigation and is an area that we hope to explore further in future research.Based on our extensive review of examples in the literature, the stages of the innovation adoption process, and the durations and challenges, are consistent with those encountered by similar, highly regulated, research intensive industries.

The industry may be missing out on key opportunities to accelerate drug development through a lengthy and inefficient process for evaluating and adopting innovations. Cross-company collaborations, partnerships with CRO and vendor partners, and regulatory guidance and clarity can support broader industry-wide adoption of innovations.We recognize that the rapid adoption of DCT solutions during the pandemic was facilitated in part by unprecedented proactive and accommodating regulatory agency involvement

At the company level, this research found that full implementation of a new technology or process in clinical operations can be achieved in under two years. Through mandates, senior leadership involvement, cross-functional engagement, financial support, better alignment of incentives, and improved change management and planning, biopharmaceutical companies can be more proactive and intentional about the way they explore and pursue innovations.

We would like to acknowledge the study’s Working Group for their contributions to this research.

*In this research we are defining “wide-adoption’ as approximately 70% of industry having decided or being in the process of fully adoping the technology or capability.

https://www.outsourcing-pharma.com/Article/2020/10/29/NoGoingBack-mission-brings-trial-pros-together

Tufts CSDD Analysis, presented at Veeva R&D Summit, June 10 2019, Barcelona, Spain

Tufts CSDD White Paper – Adoption of Innovative Technologies within Pharmaceutical R&D, May 2020

Characterizing the long-term adoption experience of clinical technologies and capabilities—and what senior leaders can do to drive adoption within their walls.

Accelerating Innovation Adoption to Support Drug Development Operations

The results of several studies published in 

 and elsewhere have demonstrated the impact of growing clinical trial data volume and the increasing diversity of clinical data sources on study timelines and inefficiencies.

New benchmarks show that the increase in data volume and diversity is accelerating. The typical late-stage protocol, for example, now collects on average 3.6 million data points, three times the number collected 10 years ago.

In collaboration with and funding from IBM Watson Health, Tufts CSDD has now completed a study assessing how the clinical data management function—internal teams in collaboration with their electronic data capture (EDC) partners—are managing, collecting, organizing, storing and analyzing their clinical data. This article summarizes the results of this collaborative study and provides more granular cycle time measures, experience with EDC solutions, insights into challenges and opportunities to optimize clinical data management practice.

A global survey was conducted between September and October 2020.In total, 194 verified unique individual responses were received and analyzed. Respondents had an average of 10.8 years of experience working in a variety of roles including clinical operations, data management, executive leadership, clinical development and others. The mean number of clinical trials performed per year was 54. In the discussion that follows, we’ve classified organizations into two primary subgroups: those conducting 50+ trials/year are designated as “Larger” and those conducting fewer than 50 trials/year are designated as “Smaller.”

Clinical data management and EDC solution pain points

More than twelve different EDC solutions were identified by respondents. Most organizations (73.9%) report using two or more and the remaining 26.1% of respondents report using only one EDC solution.

Table 1 below shows the wide range of clinical data management pain points reported. The typical respondent noted 3.3 different pain points associated with their primary EDC solution. Managing mid-study updates and their associated delays topped the list followed by flexibility and customization challenges.

 Pain Points Experienced with Primary EDC Solution

Nearly one third of respondents reported challenges with database go live delays and the lack of integrated patient engagement and electronic clinical outcome assessment (eCOA) applications. Slightly more than 30% reported challenges with the cost of their primary EDC solution. Pain points that were reported the least frequently included data incompatibility between platforms, customer support problems and solution complexity (slow user learning curve).

Although a relatively high percentage of respondents cited database go live delays as a key challenge, it is interesting to note that the cycle time between final protocol approval and the database go live milestone has not changed during the past three years.

 Figure 1 below shows that the average duration from final protocol approval to the database go live milestone has increased by one day.

The results of this study also show that the average study close-out cycle time—from last patient last visit to database lock—remains unchanged between 2017 and 2020 with organizations reporting an average duration of 36.8 days. Mid-study updates represent a time intensive challenge.Managing a mid-study update requires about half of the total time needed to achieve the initial go live release of the database, as shown in Figure 2 below. This helps explain why planned and unplanned study updates are the top reported pain points.

Granular Data Management Cycle Times Between Small and Large Companies

Looking at each of these cycle times individually, and comparing smaller vs. larger organizations, there were some notable differences. The results show that smaller organizations (<50 trials/year) are faster at early-stage data management processes whereas larger organizations (≥ 50 trials/year) are faster in late-stage processes.

Despite the challenges noted, respondents report a high level of satisfaction with their EDC solutions, as shown in Table 2 below. Database design and data collection tasks received the highest satisfaction levels with over 90% satisfied. Database closeout, the overall end-to-end process, and data processing and cleaning abilities also received high levels of satisfaction. Managing mid-study updates and the overall study cycle time received the lowest relative satisfaction scores.

Satisfaction with EDC Solution Performance Across Data Management Tasks

As noted in Table 3 below, EDC solutions received high marks with 84.1% and 82.3% of respondents satisfied with the solutions’ ability to reduce the number of manual errors and avoid costs in managing mid-study updates. Fewer respondents (75.8%) were satisfied with the ability of their EDC solutions to help them reduce delays in managing mid-study updates.

Satisfaction with EDC Solution's Management of Mid-Study Update Challenges

EDC solutions also received high satisfaction ratings for electronic data capture, randomization and endpoint adjudication (100% of respondents reported being satisfied). Over 90% were satisfied with medical coding, data integration, data management and eConsent capabilities. Electronic patient-reported outcomes (ePRO), eCOA and Study-Level Reporting received the lowest satisfaction ratings. Nonetheless, over 70% report being satisfied in these areas as detailed in Table 4 below.

Satisfaction with EDC Solution Functionality

Table 5 below shows how respondents ranked aspects of their EDC solutions and solution providers that they like least. Lack of responsiveness and poor individualized attention were among the top criticisms of EDC providers.

Least Liked Aspects of EDC Solutions and Solution Providers

Functionality was by far the top factor that influences respondents’ decision when selecting an EDC solution as shown by Table 6 below. A distant second was Ease of Use with 57.4% of respondents including this factor among their top three. The ability of a solution to handle clinical trial scope and complexity was also noted as a top factor influencing selection decisions. Customer support, pricing and reputation were among the least influential factors.

 Influence of Factors When Selecting an EDC Solution

Looking ahead – will EDC solutions and providers maintain their high marks?

Organizations look for their EDC solutions to support a wide range of data management tasks and provide a variety of functionality. This study found that—although cycle times are not improving—the majority of organizations are satisfied with their providers and EDC solutions on all accounts.

Cycle times from final protocol approval to database go-live and last patient visit to database lock—now average 69.4 and 36.1 days respectively—represent opportunity areas to accelerate. Similarly, the time required to implement mid-study updates (28.5 days for planned and 29.9 days for unplanned) against a backdrop of frequent amendments and an increasing number of adaptive design studies also represent a major area of opportunity requiring attention and improvement.

One issue highlighted by the contradictory relationship raised between challenges and satisfaction rates is the close dependency that data management has on other study tasks. Evaluating EDC solutions for efficiency or time savings remains impractical due to the many external confounders—such as the protocol approval process and amendment resolution—that impact data management cycle times.

How EDC solutions and providers can add or integrate new functionality, manage mid-study updates and reduce overall cycle times remains to be seen. This study serves as a baseline from which to measure future progress. We look forward to monitoring the progress in this highly important aspect of drug development.

The authors would like to thank Dilhan Weeraratne and Van Willis at IBM for their contributions to the project and their support in developing this manuscript.

Indupuri R, Rocchio S, Getz K, Harper B, Wilkinson, M. Enabling Digital Transformation: Managing External Clinical Data Sources to Advance Drug Development. 

https://www.appliedclinicaltrialsonline.com/view/enabling-digital-transformation-managing-external-clinical-data-sources-to-advance-drug-development

.Published November 13, 2020. Accessed January 4, 2021.

Society for Clinical Data Management White Paper. 

The Evolution of Clinical Data Management to Clinical Data Science (Part 2: The technology enablers).

. Published March 5, 2020. Accessed December 20, 2020.

Rising protocol design complexity is driving rapid growth in clinical trial data volume.

 Volume 23, Number 1. January/February 2021.

Wilkinson M, Young R, Harper B, Machion G, Getz K. Baseline assessment of the evolving 2019 eClinical Landscape. 

Therapeutic Innovation & Regulatory Science.

2020 Tufts CSDD – IBM Watson Health benchmarking study highlights need for new functionality from EDC solutions and providers.

Characterizing Clinical Data Management Challenges and Their Impact

Data has truly become the currency in our everyday lives, and the volume and speed at which it is being collected, processed and exchanged is staggering. For instance, every minute, 188 million emails are sent, 4.49 million Google searches are conducted, and 4.5 million videos are watched on YouTube.

 This proliferation of information can also be seen in the world of clinical research, where the amount of clinical data per trial has increased by 183% in the last decade.

The growing volume of clinical data illustrates one significant way in which the drug development landscape is evolving. As clinical trials are becoming more decentralized, the variety of data types and sources, including genomics, biomarkers, wearables and images, that are being used in drug development is also expanding. With the amount of diverse data that must now be collected and analyzed, the life sciences industry is faced with increasingly complex studies that present new challenges in clinical data management.

From October 4 to December 30, 2019, eClinical Solutions and the Tufts Center for the Study of Drug Development (Tufts CSDD) conducted a survey to understand the trends in clinical data management and assess how sponsors are responding to current challenges. 149 individuals in senior-level data management, data sciences, biostatistics, information technology and clinical research operations roles participated in the study. Of the respondents, 48% were one of several individuals within an organization responsible for clinical data, 33% were primarily responsible for clinical data and 19% were frequent users of clinical data systems. 

The majority of respondents came from pharmaceutical (41%) and biopharmaceutical (37%) sponsors, though CROs (10%) and independent contracts (6%) were also represented. The sizes of respondents’ organizations varied from small sponsors (30%) that had initiated an average of 2.9 trials yearly, medium sponsors (29%) that had initiated an average of 23.8 trials yearly and large sponsors (17%) that had initiated an average of 112.4 trials yearly.

Sponsors are collecting more data types than ever. Though non-CRF data is the most commonly used in clinical trials among 87% of respondents, a variety of other data types and sources are also being used. Nearly two thirds of sponsors are incorporating direct data capture, apps, devices and medical images as other data sources, while roughly one-third are using electronic health records (43.4%) and omics data (35.5%).

Data sources contributing to significant delays

The growing number of external data sources is associated with longer database lock cycle times with more than half of the study respondents citing non-CRF data as a primary contributing factor. Since 2017, this has resulted in a 40% increase in time from Last Patient Last Visit (LPLV) to database lock. Specifically, large pharmaceutical companies using four or more sources are experiencing a three-week increase in Last Patient Last Visit (LPLV) to database lock.

Last Patient Last Visit (LPLV) to Database Lock Cycle Times

Labor intensive data management activities

Although the availability of richer data sets is essential for gaining deeper insights to advance drug development, sponsors are faced with challenges in all data management activities related to organizing and reviewing the immense volume of data. Among all participants in the Tufts-eClinical Solutions study, analyzing and consuming data was rated as the least challenging of these activities, though over fifty percent of respondents still noted this activity as somewhat or extremely difficult. Of the seven key data management tasks noted in the survey, participants highlighted the process of initiating relationships with data providers as the most time-consuming and labor intensive. This highlights the opportunity for improving vendor relationships as a crucial element in alleviating difficult data management duties.

Data management activity labor intensiveness

Unsophisticated tools to centralize and standardize data

Even though the variety and volume of data continues to evolve, making data management activities more difficult and time consuming, the tools used for data integration and analytics remain relatively unchanged. 75% of companies are still using SAS as the primary tool to convert, explore and analyze data.

With the changing landscape of clinical research presenting challenges in how companies organize and review disparate data types from a multitude of sources, all participants in the Tufts-eClinical Solutions study recognized the need to find solutions. Potential areas for improvement that were highlighted included handling more external data sources, decreasing cycle times through streamlined processes, encouraging patient-centered data acquisition strategies and developing better opportunities for real-world data uses. Life sciences organizations identified several ways in which they are responding to evolving clinical data management requirements in these specific areas.

When an organization outlines a formal data strategy to determine how data will be collected, processed and analyzed, there are clear benefits to clinical research. The greatest impact is to database lock times. Database lock is accomplished 10 days faster with sponsors that have implemented a data strategy compared to those that have not. Since large companies are managing more data sources, they are also more likely to have implemented a data strategy, especially given that 53% of organizations that are using five to six data sources experience longer times to database lock.

Though there are significant benefits, only one-third of the survey respondents have implemented a defined data strategy. Almost half of the respondents were either still examining or planning a data management initiative in the next few months. This means that there is still a great opportunity for all life sciences companies to leverage the benefits of a formal data strategy in reducing trial delays.

To keep pace with the growing number of disparate data, organizations are turning to more advanced tools. The survey findings show that clinical data hubs or repositories are being used more often than other systems, including EDC and SAS-based infrastructure. However, EDC is still being used most often for specifically integrating and organizing direct data capture. Tools like clinical data platforms with robust capabilities to help data managers import, transform and review data will become powerful assets as data sources continue to increase.

Sponsors using a data hub or lake also had more confidence in their analytics capabilities in areas associated with analytics dashboards, interactive visual exploration, the ability to publish and collaborate on analytic content, and augmented data discovery.

Integrating new technology into current systems is just one element in establishing mature analytical capabilities. The survey also revealed a strong association between these capabilities and the implementation of data strategies. Over 50% of respondents who have a defined data strategy noted that their analytical capabilities are more developed.

Another benefit to having definitive data strategies can be seen in the areas of artificial intelligence (AI) and data science competencies. Organizations that have implemented a data strategy are more mature in terms of researching or implementing AI, machine learning and deep learning capabilities. These companies are also more likely to be developing new data sciences functions or specific data sciences roles. In fact, 47.2% that have implemented a data strategy have also established a data sciences function.

Developing analytical and AI capabilities is crucial to preparing for the digital transformation that is sweeping across the drug development industry. Life sciences companies must now meet the increased demand for clinical data and real-time insights from a variety of distinct sources. By automating time-consuming and labor-intensive data tasks, sponsors are able to support greater access to and deeper insights into data to drive innovation and accelerate drug submissions and discoveries.

Respondents to the Tufts-eClinical solutions survey agreed that there are tangible benefits to laying the foundation for AI and data science through formal data strategies. 85% of all respondents rated these qualities as somewhat or very beneficial:

Increased visibility of data to stakeholders for faster decision making

Decreased cycle times through more collaboration and shared analytics

Cost-savings through resource optimization and reduced rework

Faster acquisition and benefits from new real-world data sources that contribute to development


Conclusion: a new era of clinical research

In this modern era of drug development, clinical data has become one of the most valuable assets for life sciences organizations in powering digital transformation. As the Tufts-eClinical Solutions study demonstrates, delays in clinical trials, measured through database lock cycle times and through manual efforts and time-consuming processes associated with assembling data sets for review and insights will continue to increase without the implementation of new strategies. The diversity and volume of clinical data is also growing exponentially, and the tools for managing these must improve to keep pace.

Industry leaders are recognizing that evolving their approach to the research process is critical. By adopting formal data strategies, implementing modern technologies like clinical data platforms and expanding data science competencies, analytics and AI capabilities, sponsors can gain more control over the research process and drive actionable insights from new data streams to continue to push and accelerate drug development.

Anticipating the Impact of the Patient Engagement Movement on Clinical Operations

, Presentation at CROWN conference, Slide #9, January 202

With an increasing amount of diverse data that must now be collected and analyzed, the industry is faced with increasingly complex studies that present new challenges in data management.

 Enabling Digital Transformation: Managing External Clinical Data Sources to Advance Drug Development

In the battle for the war on talent, biopharmaceutical companies, particularly those in competitive markets, are having to find creative strategies to enhance their staff recruitment, engagement, and retention practices.1,2 In the 2018 Employee Tenure Survey conducted by the U.S. Bureau of Labor and Statistics, it was reported that the median tenure for wage and salary workers was 4.2 years and this has not changed in a decade.3 The tenure is even lower in the healthcare industry, clocking in at 3.5 years for the category of “health services, except hospitals.”

While these trends may not directly correlate to roles in clinical research, the numbers highlight the challenges that biopharma managers and organizations face when it comes to developing and retaining talent. Several key questions arise:

Should companies play an active role in investing in their employees’ growth and development?

What practical approaches should employees take to ensure they have a targeted plan for growing the knowledge and skills most needed to be successful in their role?

What is the best way to communicate the competency expectations of employees and set them up for success, so they perform and grow in their roles and stay with the organization?

In a large organization with multiple managers, how can consistency in the interpretation of these expected competencies be ensured?

These were but a few of the questions that the clinical operations group at Genentech has tackled over the last few years. In this article, we provide a case study for how we went about addressing these workforce challenges, where we are currently, and what we learned along the way.

Genentech, a member of the Roche Group, is headquartered in South San Francisco, a hotbed for high-tech and home to many biopharmaceutical companies. Roche, like many big pharma organizations, functions around a set of core competencies that outlines the cultural and organizational behaviors that are expected of all employees, including teamwork, collaboration, decision-making, and innovation.

These competencies include both technical (e.g., achieving results) and leadership (e.g., communication) competencies. They provide expectations for the skills, behaviors, and knowledge (SBKs; sometimes also referred to as knowledge, skills, and abilities or KSAs) that employees should demonstrate and master to fulfill Roche’s overall corporate objectives.