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?
Because of the FDA’s recent draft guidance urging sponsors to create a plan to enroll more participants from underrepresented racial and ethnic populations, research sites may feel the onus of diversity falls on sponsors alone.1 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 to serve as the framework for their diversity initiatives from trial to trial.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 needs:
- A robust definition of what diversity means for you and your practice
- 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
- 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 in line with these recommendations, be sure to revisit it every year to make sure it’s still in line with your practice’s and community’s needs.
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. Elligo Health Research® can help.
Our Elligo Research Network offers services to support you in the creation and implementation of a diversity action plan 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.
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?
- FDA Takes Important Steps to Increase Racial and Ethnic Diversity in Clinical Trials. U.S. Food and Drug Administration. Published 2022 April 13.
- Miessler, J. Effective Trial Diversity Plans Are Built from the Ground Up, Starting at the Site Level. CenterWatch Weekly. Published 2022 July 25.