Maria Florez

*See end of article for more information on methods, data analysis, and results

Over the years, there have been conflicting reports regarding workforce-related shortages in the science, technology, engineering, and math (STEM) fields. While some have cited that there is a shortage, others refute those claims, pointing instead to a surplus of STEM professionals.

 Indeed, a growing body of literature points to shortages in certain areas and a surplus of talent in others, suggesting the need for contextualizing the shortage or surplus, which may help explain the conflicting trends.

 For example, the most recent report by the Bureau of Labor Statistics reported a shortage in some occupations, such as nuclear and electrical engineering PhDs who are US citizens while pointing to a surplus among Biology PhDs aiming for academic professorships.

Given the wide breadth of disciplines and industries STEM covers, efforts have been made to understand exactly how and when shortages or surplus in talent may manifest and how they differ within certain industries. Naturally, we wonder how might these trends emerge in the drug development industry? The area of drug development provides an opportunity for a nuanced understanding of talent trends given the industry’s cross-disciplinary nature, spanning the biological sciences, engineering, statistics, and data science, to name a few. Gaining accurate insight into talent trends can better equip organizations to adapt and plan their employee recruiting and retention strategy to ensure they are attracting, developing, and retaining the appropriate talent. Yet, to date, very few studies have examined the workforce development needs in the pharmaceutical industry. In fact, only a handful of studies have explored talent trends in the pharmaceutical workforce, with very few focused on labor patterns in the US.

For instance, turnover rates remain high among FDA-regulated principal investigators, while the number of registered trials has grown.

 This trend coupled with the increased complexity of protocol design point to growing demands for experienced professionals who can manage and navigate the growing complexity and intricacies of clinical research.

To enhance the body of research on workforce trends in STEM, Tufts Center for the Study of Drug Development (CSDD) set out to investigate the state of the talent pipeline within drug development from leadership’s perspective. Thus, the purpose of this study was to explore perceptions among senior leaders to gauge their experience related to workforce trends in drug development. Following are our results, broken into four sub-categories.

The data revealed four main types of shortages, which were 1) diversity-related shortages; 2) shortages related to experienced hires; 3) role shortages; and 4) skill shortages. Diversity-related shortages dealt with the inability to find and hire diverse talent. Several shared that though they are seeing improvement in gender representation, the talent gap related to racial minorities was still present, particularly among Black professionals. When asked about possible drivers of this gap, several participants attributed the gap to a pipeline issue stemming from there not being enough college graduates from diverse backgrounds who pursue STEM careers. Interestingly, one executive working at a large, global pharmaceutical company shared that in their area, they noticed less representation for Native American and Hispanic/Latinx talent than Asian or Black professionals. Further, while a few executives shared that Asian employees were well represented in their organization, it was shared that a large portion of their Asian talent were international, not Asian American. One executive attributed Asian representation to the organization being an Asian company based in Asia, and hence having a large Asian representation.

The second type of shortage related to finding experienced hires at the management level and above. This was especially pronounced because a lot of professionals from the baby boomer generation, those in their sixties and older, are retiring. One executive mentioned that their organization had a difficult time filling the gaps left by those who were newly retired, resulting in inflated titles due to rapidly promoting inexperienced people who may not have all of the qualifications to step into the senior leadership role. Relatedly, another participant mentioned that this particular phenomenon is making it difficult for smaller firms to compete for talent given that smaller firms cannot match larger organizations that can provide the titles and the associated compensation and incentive.

Shortages related to specific roles also emerged from the data. Example of roles that were in short supply included: clinical pharmacologists, data scientists, and statisticians, as well as project managers, frontline clinical research associates (CRA), the latter of which were in short supply in clinical operations. Additionally, there seemed to be a higher turnover among contract research organizations than sponsor organizations.

Lastly, participants noted that certain skillsets were in short supply and high demand. The most frequently mentioned in-demand skillsets that were increasingly difficult to find were analytical and technical skills—namely data engineering, data science, statistics, and math. Several participants shared that the ability to analyze large quantities of data and communicate the relevant findings to stakeholders has become paramount and that this particular skillset is lacking in a lot of roles within drug development. Furthermore, a few noted that even roles that traditionally did not require strong expertise in data analytics, such as CRA roles, are now requiring candidates to possess at least some level of data analysis, and that finding candidates who possess both CRA and data skills has become a challenge. We also found that there is a growing demand for people possessing a blend of data science and drug development expertise who can easily navigate the complexities of the drug development process.

It was noted that big data is changing every aspect of the drug development process, from discovery to commercialization. For example, late-stage products—those in Phase III onward—are being developed using a traditional approach to informatics. In contrast, early-stage products—those currently in preclinical through Phase II—are being developed with the assistance of artificial intelligence (AI) and machine learning (ML). This fast-paced transition will require a large number of personnel with advanced engineering, data science, analytics, project management, and leadership skills. While the number of new roles that require these skills has expanded, the pool of individuals with these skills has lagged.

In this section, we examine overall drivers of this disparity, as well as factors that worsened certain types of manpower shortages. Drivers were classified into (1) external factors—aspects that are exogenous and beyond the scope or control of any given organization, and (2) internal factors—aspects that are endogenous and, to some extent, within the scope or control of an organization.

External factors include socio-contextual events, such as the COVID-19 pandemic—and the “new economic paradigm” that emerged because of it (including increased consolidation of the pharmaceutical sector through mergers and acquisitions (M&A), and increased public and private funding for all stages of the biopharma development process); lack of awareness among students and young professionals about career opportunities in drug development; pipeline problems (which many referred to as a “talent drain”); the retirement of the baby boomer generation; and drastic cultural changes within the drug development industry.

The COVID-19 pandemic (and the economic environment that followed)

Participants shared that during the pandemic, sponsors and their vendors (e.g., CROs, etc.) lost a high volume of staff due to burnout and illness. Employees faced increased work responsibilities, while being simultaneously burdened by additional at-home obligations such as home-schooling and caretaking, a finding that mirrors challenges faced in other industries as well.

 Sponsors were better able to recruit compared to vendors, but the impact of labor shortfalls experienced by vendors was passed onto sponsors. Further exacerbating the labor shortage is the highly collaborative nature of biopharmaceutical development that requires global teams working across geographical regions and time zones, necessitating people working to cover meetings with partners in Europe and Asia. In the face of a staff shortage, coupled with growing demands from government, investors, and the public for rapid drug development strained the already long work hours the biopharmaceutical staff has been accustomed to. As one study participant noted, 

“This all leads to long work hours, so people leave.”

The data also showed that biopharma turnover rates—historically perceived as high compared to those of other industries—were exacerbated by the pandemic. By normalizing remote work, the pandemic led to the reduction of geographic barriers to recruitment, thereby increasing job mobility for individuals with STEM backgrounds (especially in data science and statistics), project management experience, and leadership skills. Skilled workers were able to leave their jobs for better pay at competing biopharmaceutical companies, as well as in other industries. However, in cases where remote work was not possible and geographic barriers to recruitment persisted (i.e., biopharmaceutical manufacturing and on-site clinical operations), turnover remained high and was perceived to be caused by low salaries and/or low levels of flexibility.

The pandemic also had important implications for recruitment of STEM PhD students into the biopharma industry. Many had to pause their research and dissertations as universities and laboratories shut down. The closing of elementary schools and high schools also had implications for PhD students with children; this led to an increase in homeschooling and other caretaking responsibilities that delayed completion of PhD studies, reducing the pool of candidates available to the biopharmaceutical industry.

The “talent drain” was frequently cited as a top contributor to the workforce shortage. Most notably, participants shared that college students often lack awareness of the biopharmaceutical industry, its mission, and its workings, citing this gap as a missed opportunity to encourage young talent to pursue careers in drug development. Second, participants conjectured that that there may be barriers for many students to pursue advanced STEM degrees, creating a gap in the pipeline early on. As an example, participants noted that graduate students in the United States are often underpaid (if paid at all) during their university years. Graduate student salaries are often barely sufficient to cover living expenses, especially in high cost of living cities such as Boston, San Francisco, San Diego, and New York, home to universities that offer competitive college degrees in STEM, which hinders students from pursuing advanced degrees in STEM. Third, barriers related to retaining international talent (i.e., lengthy, costly, and uncertain processes to obtain a work visa) were cited repeatedly as an external factor in STEM shortages and a major driver of the “talent drain.” Consequently, companies and their leaders are struggling to hire and retain top international STEM talent who complete their graduate education in the US.

The data also highlighted internal drivers of STEM workforce shortages. These include lack of professional development in companies to develop, train, and retain their talent; outdated Human Resource practices that do not keep up with current needs; and systemic racial and gender bias among hiring managers.

Challenges related to professional development revolved around lack of training opportunities that would equip professionals with skills in leadership, technology/data science, and life science.It was shared that while it is easy to find someone who possesses one or even two of the three areas, it is rare to find individuals who have relevant experience in all three domains. Several participants went onto share that their company does not have the resources dedicated to train individuals, citing that many of the training programs were either ad-hoc or insufficient, if they existed at all.

Traditional approaches to Human Resources practices and requirements were cited as a contributing factor driving the shortage. Though more flexibility is required, such as opportunities to broaden employees’ experiences and leadership capabilities within the company, participants shared that their organization’s professional development strategy often did not have the flexibility or the capability to help develop and retain employees. This is ever more important for technical experts who want to develop leadership capabilities and manage teams. However, it was also shared that not all technical experts want to become managers—and may not be suited for managerial positions. Thus, a flexible approach to talent development that takes into consideration the needs and skillsets of employees rather than a one-size-fit-all approach was advised.

The STEM shortage has had an impact on many aspects of the drug development process, which fell into two main categories: impact on employees and impact on the organization. Participants shared that their employees cited both the frequency and severity of burnout and the associated frustration and negative impact of burnout on their quality of life. This is particularly true for employees who have skills and talents that are in high demand because they are constantly pulled into different projects and as a result become overworked. In contrast, participants shared that employees who lack the skills that are in high demand often felt left behind and frustrated by the ever-increasing pace of change that requires constant and mandatory adaptation, noting that adequate guidance and tools are often lacking, exacerbating their frustration.

Organizational areas that were impacted ranged from stifled innovation to budgetary strains. First, the shortage has led to stalled innovation due to extended timelines to accommodate staffing shortages as projects scramble to find people who have the necessary skills to compete projects in a timely manner. This has been linked to a reduction in the speed of development for targeted therapies, as well as the obstruction of opportunities to develop medicines faster. Second, the shortage has increased the training costs for new hires. New hires are rarely ready-to-go, often needing extensive training and guidance to be brought up to speed. This takes time away from product development and project execution. Similarly, high levels of investment are required to retrain existing staff and develop their leadership skills to prepare them for leadership roles. Third, the shortage has put a strain on company budgets, specifically driving up the need for funds to hire external consultants to meet the staffing shortage, contributing to the increase in development costs.

In the face of such challenges, participants shared a few strategies they are using to address the gaps. Here we will present the top strategies related to attracting, developing, and retaining the talent pipeline. Participants revealed that they have been trying to increase candidates in their selection pool by targeting college and graduate students, as well as young professionals. To do so, their organizations are investing in creating internships to provide paths for potential candidates to seek careers in drug development. Another commonly cited strategy was investing in training. The majority of those interviewed emphasized the need to invest in training, which included on-the-job, hands-on training to equip professionals with the necessary skills required for their role; upskill training that focused on training individuals to be equipped with necessary skills for the next level; and training to give professionals exposure to different functional areas to encourage lateral moves across functions within the industry. Lastly, the need for leadership development programs to train scientists to become better managers and leaders was also shared among the participants, underscoring opportunities to drive retention among professionals.

Our study helped shed light on specific talent trends in the drug development industry. By interviewing executives from a range of areas within drug development, we were able to uncover common themes regarding their perceptions of shortages related to diversity, skills, and roles. The shortages related to racial diversity mirror trends from other areas in STEM, showing a persistent gap in racial minority representation. While many of the executives we interviewed were aware of the benefits of hiring and retaining a racially diverse workforce, most attributed the racial gap to a pipeline problem. More specifically, the most cited driver of this racial disparity was lack of available candidates in the hiring pool, commonly referred to as the “not enough qualified Black talent” factor, which has been critiqued and countered.

 While it is true that compared to Asians and Whites, fewer Black and Latino candidates graduate from STEM programs, not dedicating the time, resource, and energy to actively target and recruit racially diverse candidates who are graduating from STEM programs, and not looking beyond one’s network is likely exacerbating the representation gap.

 Thus, the challenge is not that these diverse candidates simply don’t exist, but that they are not present in 

 candidate pools and that their smaller numbers will make it more difficult to find them, highlighting the need for investing more time to expand the talent pool to search for them.

Our findings also underscore specific skillsets and roles that are in high demand. As organizations become more sophisticated with the types and amount of data they collect to drive the drug development process, so do the skillsets required to manage the growing needs around managing, analyzing, and making sense of the data. Importantly, we highlight how the shortage has affected and will continue to impact the rising cost of drug development, necessitating more investment to fill the pipeline, develop and train employees, accommodate flexible work arrangements, and raise awareness among college graduates and young professionals about career opportunities in drug development.

Recruitment was done primarily through word-of-mouth referrals. Potential participants were contacted through email and invited to participate in a one-hour virtual interview to share their perceptions and experience dealing with their STEM talent. The study received IRB approval from the authors’ institution.

A total of 10 semi-structured interviews were conducted over Zoom by the two authors. 6 out of 10 were women. The average age was 47.9 years, and the average work experience was 24.6 years. Most had a graduate degree. For more details regarding the study participants, see Table 1.

We used a semi-structured interview guide consisting of general, open-ended questions as well as follow-up questions meant to probe for more details. Sample of general questions include: “What has your experience been with workforce shortages in your functional area?” and “What might be driving those shortages?” Example of follow-up questions include “What has been the impact?” and “How has your organization been dealing with the shortages?”

Interviews were transcribed verbatim using the transcription feature on Zoom and then manually checked by the authors to ensure accuracy. We used a thematic approach for coding and analysis, which allows for themes to emerge from the data.

 This process involved open coding that allowed us to capture a range of different incidents, which were subsequently consolidated under themes. The two authors independently coded the transcripts. During this process, we met regularly to discuss emerging themes and reconcile any discrepancies in the coding process, while consulting the literature on workforce shortages in STEM to guide our coding.

Next, we will present the findings of the study related to 1) the types of workforce shortage; 2) drivers of the shortages; 3) impact of the shortages; and 4) strategies being used to address the shortages. Of the 10 executives we interviewed, all confirmed that they experienced some form of workforce shortage within their organization, function, or team.

, PhD, Research Assistant Professor, and 

, MA, Senior Analyst and Research Consultant; both with the Tufts Center for the Study of Drug Development

Industrial Capabilities: Report to Congress

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Articles

Tufts CSDD study breaks down state of the talent pipeline from lens of senior leaders.

Workforce Trends in Drug Development

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

Survey methodology and data characteristics

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

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.

Maria Florez

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