Diana Foster, PhD

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,”

 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 (

), 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 Program

 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:

In 2016-17, conducted a pilot study with randomly selected 12 clinical research sites to explore factors affecting enrollment of diverse populations in clinical research trials. Factors investigated in this pilot study included beliefs regarding their community (i.e., estimated racial/ethnic makeup of the communitywhere the site is located, racial/ethnic makeup of patients that the principal investigator typicallyenrolls), demographics of patient diversity, research staff diversity, staff linguistic capabilities, patientrecruitment activity regarding extent of activity, implementation, barriers, perceived importance,frequency of Sponsor requests, cultural competency training and access to patients. The results of this study are available in an SCRS white paper.

In 2017-18, conducted a larger, comprehensive study of clinical sites that explored the relationship between site commitment, efforts, incentives, community connections, reinforcement actions, presence of multilingual and culturally competent staff along with understanding the community in which they serve and perceptions about successfully recruiting diverse populations. The results of this study are available in an SCRS white paper.

In 2018-19, identified the need for a self-assessment tool to provide guidance for sites to improve their ability to recruit diverse patient populations. In partnership with stakeholders from the industry, SCRS established a diversity working group that developed a 27-item checklist that consisted of statements representing best practices in recruitment of diverse patient populations for clinical trials. This checklist was tested for its psychometric properties both qualitatively and quantitatively resulting in a 25-item tool named Diversity Site Assessment Tool or DSAT. The results of the qualitative and quantitative assessment of DSAT’s psychometric properties are also published.

In 2020-2021, SCRS surveyed representatives from clinical trial sites who were part of several databases (SCRS membership database, LinkedIn and other social media platforms where contacts with known affiliation to clinical trials industry). The survey consisted of the DSAT and a section on demographics about the participant and their site. These are detailed with the methodology and full tabulated results 

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.

 Numerous industries have long integrated self-assessment practices successfully as part of its quality improvement strategies.

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.

 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.

Guidance, Food and Drug Administration. Enhancing the Diversity of Clinical Trial Populations—Eligibility Criteria, Enrollment Practices, and Trial Designs. Accessed on March 15 20, 2021. Accessed from: 

https://www.fda.gov/media/127712/download

SCRS Launches Diversity Awareness Program. PRNewswire. 2017. Accessed: March 20, 2021. Accessed from: 

SCRS Launches Diversity Awareness Program (prnewswire.com)

White Papers. The Society for Clinical Research Sites. Patient Diversity Awareness: Developing a Better Understanding of the Knowledge, Expertise, and Best Practices at Clinical Research Sites to Meet the Needs of an Increasingly Diverse United States Population. Accessed: March 24, 2021. Accessed from: 

http://myscrs.org/learningcampus/white-papers/

White Papers. The Society for Clinical Research Sites. Recruiting Diverse Patient Populations in Clinical Studies: Factors that Drive Site Success. Accessed: March 24, 2021. Accessed from: 

Foster D. A Pilot Study to Examine the Validity and Reliability of a Site Assessment Checklist for Evaluation of Best Practices of Recruitment of Diverse Patient Populations for Clinical Trials. Insite: The Global Journal for Clinical Research Sites Summer 2020: Page 10-19. Available at: 

https://cloud.3dissue.com/180561/181052/211361/InSiteS ummer2020/index.html

Foster D. The Diversity Site Assessment Tool (DSAT), Reliability and Validity of the Industry Gold Standard for Establishing Investigator Site Ranking. Integr J Med Sci [Internet]. 2020; 7:13. Available from: 

https://mbmj.org/index.php/ijms/article/view/266

Jackson S. Achieving a culture of continuous improvement by adopting the principles of self-assessment and business excellence. International Journal of Healthcare Quality Assurance 1999; 12(2):59–64

Bose S, Oliveras E, Edson WN. How can self-assessment improve the quality of healthcare. Operations research issue paper. 2001;2(4):1-27.

Figure 1. Self-Assessment Data Driven Solutions to Addressing Diversity Issues in Recruitment of Patients in the Clinical Trials

Figure 2: Opportunities for Improvement in Diversity Recruitment, Summary of Findings

Site tracks progress toward established diversity goals and knows what marketing or outreach strategies works to make them successful

When needed, site conducts outreach to minority-based organizations to establish a network of referrals (e.g., churches, community centers, food banks, medical community, patient advocacy and support groups, etc.)

If allowed by state/local regulations, site accommodates working patients by offering hours of operation outside of normal business hours (i.e., early arrivals and/or after hours appointments) and weekend visits

Site offers phone prompt for most frequently used languages (i.e., press 1 for Spanish)

When needed, site has provisions for providing a place to stay for patients and their family members including children

Private Practice that Conducts Clinical Trials

When needed, site utilizes appropriate media outlets (radio, TV, social media) specific to the targeted population

Research Company in a Hospital or Physician Office

Investigator, Study Coordinator, and/or support staff are culturally representative of the patient population

Site routinely requests materials (e.g., ICF, patient recruitment materials, patient outcomes assessments, E-diaries) in languages predominantly used by members of their patient population

Site provides transportation services or requests reimbursement from sponsor as needed

Research Departments (RDs) in a Hospital, Owned by Hospitals

Stipends are offered and/or distributed in a timely manner and method easy for patient use

Site creates target patient population specific retention plans

Informed Consent form is available, pre-translated and pre-IRB approved in relevant languages

When needed, site partners with sponsor to create study-specific, target patient population specific recruitment plans

Site has an established tailored strategy to approach targeted populations for clinical trials

Articles

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. 

Diana Foster, PhD

Articles

Identify Opportunities to Improve Diversity Recruitment