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While it's important to note that there are areas where the industry can improve, there are unique opportunities of improvement for specific types of sites and the number of studies conducted there.
For over a decade, stakeholders in the pharmaceutical development and approval processes have deliberated on an important question: how do we ensure that the patients enrolled in our clinical trials are representative of the population which will use the products developed by the pharmaceutical and biomedical industry?
One of the important stakeholders who has provided guidance on this issue is FDA. In its guidance, “Enhancing the Diversity of Clinical Trial Populations—Eligibility Criteria, Enrollment Practices, and Trial Designs,”1 the FDA offers numerous recommendations on how product sponsors should develop practices that could improve participation of diverse populations. Specifically, FDA has identified that sponsors need to be considerate about improving issues related to visit frequency, use of electronic communications to replace visits and engagement with patient advocacy groups and patients to gather suggestions for designing trials that participants would be willing to enroll in and support. Since many of these activities happen at the site, level, The Society for Clinical Research Sites (SCRS), founded in 2012 in response to the growing need for a global organization representative of the needs of clinical research sites, embarked on its own diversity initiatives.
SCRS developed its Diversity Awareness Program2 to generate an assessment of issues pertaining to recruiting diverse patient populations in clinical trials, engage stakeholders in the dialogue and development of resources that would help strengthen site preparedness for a more diverse recruitment of minority patients. SCRS, along with its partners, have conducted the following activities under the Diversity Awareness Program:
Within the realm of organizational behavior and performance improvement literature, it is widely acknowledged that self-assessment is an important yet an underappreciated avenue for organizational improvement. This literature defines self-assessment as a systematic and a comprehensive review of the organization that allows the identification of strengths and weaknesses and leads to actions aimed at functioning, process improvement and the broad use of innovations.7 Numerous industries have long integrated self-assessment practices successfully as part of its quality improvement strategies.8
Figure 1 illustrates how the DSAT can be of high utility for these organizations. Once DSAT is used for self-assessment https://myscrs.org/dsat/ and data is available, then organizations can use the data to identify strengths and weaknesses and engage in a discussion to identify which areas to address and the solutions or resources pertaining to those areas of need. During those discussions, organizations could look within its organization for expertise, or reach out to other stakeholders like the SCRS and FDA to help it identify the best solutions and resources.
Once appropriate solutions or resources are identified, the organization can identify a time frame and dedicate appropriate resources for its implementation. Under the principles of continuous quality improvement, organizations can then close the loop by conducting another self-assessment and gauging the effectiveness of their solutions or resource allocation initiatives to further strengthen the quality of the efforts expended by the organization.
It is important to note that the utility of DSAT isn’t just for individual organizations. Notably, when DSAT is used within a clinical research site organization for self-assessment by members who are part of the clinical trial recruitment process, the data can help the site identify their own strength and weaknesses associated with the best practices in the recruitment of diverse patient populations. However, DSAT could also be used as a peer comparison tool to allow for benchmarking and can be used at the holistic industry level and its subgroups level to identify areas in recruitment of diverse populations that need to be addressed.
For example, Figure 2 shows how the results from the large DSAT survey can be used at various clinical research site models to improve recruitment of a diverse patient populations in clinical trials.
Insightful observations can be made based on responses collected from a large sample of respondents working in the clinical trials industry. Based on the responses received from all participants, it is evident that the clinical trials industry and its members would benefit from a discussion of how to establish diversity goals at the site level. From a structural perspective, it is crucial that these goals are developed, and stakeholders not only come up with strategies that would help sites track progress towards those goals but also conduct an evaluation of what strategies work or do not work in achieving the goals. Without such work, making meaningful progress in enhancing diversity of patient populations in a clinical trial would remain a big challenge.
Our analysis showcases that while it is important there are many common areas where the clinical trials industry can improve, there are unique opportunities of improvement that are more relevant to specific types of sites and the number of studies conducted at those sites. This analysis indicates that the DSAT has utility at multiple levels, the industry, subgroups and potentially at the individual level. As it gets integrated into continuous quality improvement initiatives within the clinical trials industry, the value of DSAT will further help highlight the progress towards ensuring diversity in clinical trials recruitment.
Diana Foster, PhD is the Vice President of Strategy and Special Projects for Society of Clinical Research Sites (SCRS)
The research and development of this research was supported and generously sponsored by Janssen, Merck, GSK, Medidata, Pfizer, PhRMA, Roche, Syneos Health, Acurian, Bristol Myers Squibb, Lilly, Parexel, VirTrial, and Total Clinical Trial Management.
Clinical Trials Industry as a whole
Private Practice that Conducts Clinical Trials
Research Company in a Hospital or Physician Office
Research Institutions (RIs)
Research Departments (RDs) in a Hospital, Owned by Hospitals
Freestanding Research Centers