By Diana Foster, Ph.D., VP, strategy and special projects, Society of Clinical Research Sites (SCRS)
Across the board, stakeholders in the pharmaceutical product development and approval process have recognized the importance of recruiting diverse patient populations in clinical trials. For example, over the past few decades, FDA policies and guidance have aimed to promote practices that lead clinical trials to be more representative of the population(s) most likely to use the product once it is approved. More recently, the FDA published draft guidelines in June 2019 that provide insights about enhancing the diversity of clinical trial populations in terms of eligibility criteria, enrollment practices, and trial design.
Diverse enrollment in clinical research studies is a complex issue that has multifaceted implications for clinical research sites. This includes cultural biases, language barriers, lack of understanding of patient demographics, and the related science behind the need for medications to be tested in specific populations, among other key elements. An understanding of the research site community’s perceived awareness and current ability to enroll these populations is lacking in the clinical trials landscape. Much of the literature related to diversity focuses on the patient perspective instead of that of the research site. With a goal of better understanding and measuring site beliefs and knowledge of the topic, the Society of Clinical Research Sites (SCRS) embarked on a mission in 2016 to take on the challenge and started the SCRS Diversity Awareness Program. The goal of the Diversity Awareness Program is to educate, inform, and heighten awareness of the importance of establishing best practices that support diverse trial enrollment in support of the research site.
Over the last four years SCRS has developed this concept and formed a working group representing industry, sites, and the FDA to focus on this goal. Some of the results of this work can be found on the SCRS website, including two research papers: (1) 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, and (2) Recruiting Diverse Patient Populations in Clinical Studies: Factors That Drive Site Success.
A soon-to-be-published third paper will be titled A Pilot Study to Examine the Validity and Reliability of a Site Assessment Checklist for the Evaluation of Best Practices in Recruiting Diverse Patient Populations for Clinical Trials. This final paper will complete the initial reliability and validity of the Site Assessment Checklist, which aims to measure sites’ assessments of their diverse recruitment practices. The goal of this project is to use the results to help sites identify what areas they need to improve upon. This will be helpful for sponsors to use as a tool for site selection and feasibility. This checklist is meant to be used by sites to self-assess their own practices and develop an action plan for improvement. It was also important to examine and evaluate the psychometric properties of the checklist before sites used it for self-assessment.
The learning to date, which will lead to future studies related to building resources to support research sites, falls into several categories. The key takeaways indicate that success in recruiting diverse patient populations is multifactorial. Successful sites have a higher commitment and make more efforts than less successful sites. These commitments and efforts appear to be geared toward:
- Developing more community connections
- Providing incentives to staff and patients
- Hiring providers and staff that can speak the language that the majority of the patients speak
- Providing training for staff to become culturally competent
SCRS members indicate varying levels of success in recruiting target diversity patient populations for their clinical studies. In particular, more successful sites report more community connections, provide incentives to staff and patients, have culturally competent staff who are linguistically matched to the patient population, engage in reinforcement actions to promote diversity recruitment, and work with sponsors that reinforce diversity recruitment through provision and development of materials that are linguistically/ethnically and culturally diverse. The overestimation of the non-white patient population and underestimation of the white patient population by successful sites is interesting to note and needs to be explored in the context of community connections and efforts toward diversity recruitment.
The results of this study should be utilized to create awareness among research sites about important drivers of diversity recruitment success and inform the development of interventions that sites can use to enhance their ability to recruit diverse patient populations in clinical studies.
The project will continue to address research sites’ responses to disparities in clinical trials now and in the future. As sponsors strive to garner a broader cross sampling of ethnic, racial, and other diverse populations, this topic will only grow more important to clinical researchers. Barriers that hinder minority participation include a lack of awareness of trials, lack of accessibility, and lack of education and knowledge. Increasingly, prioritizing diversity in clinical trials will require sites to broaden best practices, increase the accessibility of clinical trials, and prioritize employment of diverse professionals at clinical research sites, among other factors.
The many sponsors of the SCRS Diversity Awareness Program, including Merck, Janssen, GSK, Medidata, Roche, Acurian, PHARMA, Lilly, Parexel, VirTrial, and Syneos Health, are intrigued by the cutting-edge opportunity SCRS is providing through the various projects being carried out by the group.
If you are interested in participating in the SCRS Diversity Awareness Program, please contact Dan Milam, VP, Global Engagement, at firstname.lastname@example.org. The working group is eager to add more interested sponsors and research sites in the planning process in the future.
About The Author:
Diana L. Foster, Ph.D., serves as a consultant to the Society for Clinical Research Sites as VP of strategy and development, responsible for building relationships with industry that help amplify the voice of the clinical research site. She has designed and facilitated site management and patient recruitment training across the globe. While serving as president at DAC Patient Recruitment Services, Foster led the organization through its evolution as a niche site management organization. Over the past two decades, she has addressed audiences across five continents, published multiple papers and articles, and written five authoritative industry books including Global Issues in Patient Recruitment and Retention.