The 2021 WCG Avoca Industry Survey was designed to gain deeper comprehension of respondents’ values, views, and experiences regarding diversity in clinical research execution and clinical research participants. The 101 respondents included clinical research personnel from 64 sponsor companies, 35 providers, and two academic research organizations. Approximately 38% of respondents held positions within clinical development/operations, 34% within quality assurance, and the remainder within a wide spectrum of management and functional roles.
Survey respondents were asked to rate the importance of different types of diversity (i.e., racial/ethnic, gender, socioeconomic, etc.) to clinical research quality on a scale of 1 (no importance) to 5 (critically important). They were then asked to indicate whether their importance ratings were driven mostly by scientific, regulatory, ethical, or marketing and sales considerations. The impacts of “demographic” variables including respondent age, time in company, time in role (irrespective of company), functional area, and location were then investigated using multiple regression and ANOVA techniques.
Results
Why Diversity is Important vs. How Important It Is
Relationships between the reasons participants felt that diversity was important and how important they felt it to be were examined. The hypothesis was that feelings about diversity’s importance might be stronger if the propelling values were, e.g., scientific or ethical as opposed to regulatory or marketing. In general, this was found to be true. Across all aspects of diversity, respondents whose ratings were driven by scientific or ethical considerations felt more strongly about the importance of diversity than did those who felt diversity to be important primarily for regulatory or marketing reasons.
Discussion
The goal was to better understand what drives differences across research personnel in how critical diversity among clinical research participants is believed to be. Understanding these differences and drivers may provide insight into motivational factors that underlie the disconnect between the stated importance of diversity (by groups of research professionals) and the DEI-related results achieved and may thus inform efforts to improve performance in this respect. Of the variables explored, time in role was, by a margin, the strongest predictor of the perceived importance of every aspect of diversity explored, with longer times in role associated with lower importance ratings for diversity. These effects were independent of the effects of age, functional area, location, and time in company.
Responses to open-ended survey questions requesting the rationale for provided responses shed light on important themes that may be at work. Most respondents described cultural difficulties and structural restrictions that posed challenges to incorporating DEI in clinical research, including “upper management stagnation” and hesitance to depart from “old ways.” One respondent in clinical development implied a lack of open-mindedness at the senior levels at which decisions were made: “Top decision-making people have to fund, invest, trade... and for that, they first have to be open-minded….” Disincentives for doing things in new ways were also described, including the “old school sponsor mentality that it must always be done a certain way because that way has proven successful in the past. There is a place for risk management built in, yet the folks executing the trial have hoops to jump through…such that it becomes a disincentive to be a leader in the unknown…to be an innovative trial leader.” One respondent mentioned the increased costs associated with DEI initiatives: “When it increases costs and/or prolongs the time to enroll the target numbers in all subgroups, then sponsors and shareholders are going to need to be sold on this”; and another called for “education based on solid evidence that variability and flexibility [in clinical trial execution, that would support diversity] will be accepted by regulators.”
Understanding the patterns unveiled in this study’s analyses can inform policies and programs designed to effectively encourage personnel to make diversity-oriented decisions. If people motivated by scientific and ethical considerations are more likely than others to make decisions that prioritize diversity, then perhaps education surrounding the scientific and ethical rationales for diversity, and selection of leaders who understand and embrace this rationale will lead to more diversity-oriented decisions. Further, as senior staff will always play key roles in determining how clinical research is executed and will make such decisions based on their own beliefs and experiences, it is important to augment the findings of this study, which included only a minority of respondents in this category, by expanding participation of such individuals in the dialogue to more fully understand their perspectives.