Diversity in clinical research is certainly trending, and for good reason. But resolving the industry’s diversity problem requires something more than a quick, trendy fix. To increase diversity in clinical trials, the entire research industry needs to participate. What do we mean?
Per the FDA Omnibus Reform Act of 2022 (FDORA), sponsors are required to create a plan to enroll more participants from underrepresented racial and ethnic populations.1 Because of this new law, research sites may feel the onus of diversity falls on sponsors alone. But expanding access to research as care for historically underrepresented communities is impossible without site involvement. Sites, meaning doctor’s offices, hospitals, and other local healthcare centers, have the power to break down common barriers to research participation as they are physically close to where their patients live, have strong ties to their communities, and, most of all, have their patient’s trust.
As a research site or a healthcare practice looking to get into research, you may be asking, “How do I harness that power? How can I leverage my connections to the community to increase research participation?”
Create a Diversity Action Plan
One way forward is creating a diversity action plan. Angela Tootle, interim IRB director of Augusta University, told CenterWatch Weekly she recommends sites make diversity action plans tailored to their community that will serve as the framework for their diversity initiatives.2 Diversity action plans serve four main purposes. First, they save time and redundancy as they can be used on or adapted for every trial. Second, they help quickly train new staff in diversity initiatives. Third, they make sure everyone on a site’s team has a clear understanding of their responsibilities when it comes to diversity. And fourth, diversity action plans help sites keep track of their diversity goals and how they are progressing toward those goals.
Your site has unique diversity needs and goals, therefore requiring a unique diversity action plan. However, there are several attributes a good diversity action plan should have:
- A robust definition of what diversity means for you, your practice, and your community
- Why you need a diversity plan
- Your diversity goals, or what you envision as an ideal future of diversity for your practice
- How those goals meet the needs of your patient population and diverse members of your community
- An outline of how you will reach that ideal future of diversity, including timelines and specific steps
- Clear allocation of staff responsibilities when it comes to diversity
- An accountability statement to hold you and your staff to the promises and strategies outlined in the plan
After creating your diversity action plan, be sure to revisit it every year to make sure it’s still in line with your practice’s and community’s needs.
Go Beyond a Plan
Creating a diversity action plan is just the first step — you also need to implement concrete tactics to increase diversity at your site. But what tactics should you employ?
Clinical Pharmacology and Therapeutics published the results of a survey intended to uncover what diversity tactics work best at trial sites in the United States.3 You can use the tactics explored in this survey as inspiration for how you can sustainably work to increase diversity at your site.
According to respondents, the top 10 most impactful are:
- Free or subsidized transportation
- Translators and translated informed consent
- Participant compensation
- Bilingual staff members
- Sponsor funding for diversity measures
- Translated study participant education materials
- Implicit bias training for staff
- Telemedicine study visits
- Translated study participant advertisement materials
- Weekend participation visits
Whether they focus on physical or linguistic accessibility, financial support, or trust in the provider, all of these strategies are impactful because they make research participation as easy as possible. After all, not everyone has a car or gas money to make it to your site for protocol visits, and some people might not be able to leave their homes at all. Similarly, not everyone speaks English, has time off during the week, or feels comfortable at a doctor’s office or other healthcare location. As demonstrated by this survey, patient centricity is of the utmost importance when it comes to research diversity.
Need Help Increasing Diversity in Clinical Trials?
Whether you’re an established site or new to research, the significant demands on your time might stand in the way of you making a diversity action plan and implementing diversity-boosting tactics. Elligo Health Research® can help.
Research Partner Services, available exclusively to members of the Elligo Research Network, can support you in the creation of a diversity action plan and the execution of planned strategies so you can bring research as care to more patients in your community and beyond. For example, member sites enjoy a range of customizable solutions to help reduce the research burden, giving them more time to focus on diversity initiatives. Notably, our Reimbursement Analysis: Contracts, Budgets, Regulatory Overview services support sites in contract, budget, and regulatory processes, many of which take up significant resources that could be better spent on patient care and diversity. There’s also our End-to-End Research Support program, a comprehensive training and infrastructure package designed to make serving as a research site as simple and straightforward as possible.
The Elligo Research Network also focuses on maintaining and supporting the trusted patient-physician relationship throughout the study process, a commitment that naturally increases research diversity and expands access to research as care.
Take Control Over Research Diversity at Your Site
As a current or potential research site, you are in a unique position in which you can bring research as care to those who wouldn’t otherwise experience the benefits of participation. The Elligo Research Network is here to help you make the most of that position. Are you ready to get started?
- H. R. 2617. Authenticated U.S. Government Information GPO. Accessed 2023 Feb. 17.
- Miessler, J. Effective Trial Diversity Plans Are Built from the Ground Up, Starting at the Site Level. CenterWatch Weekly. Published 2022 July 25.
- MacLennan, D.L., et al. Clinical Trial Site Perspectives and Practices on Study Participant Diversity and Inclusion. Clin Pharmacol Ther. Published 2022 Dec. 10.