How can we improve diversity, equity and inclusion in clinical trials? - MRN

How can we improve diversity, equity and inclusion in clinical trials?

by Irina Morris

Last month I attended SCRS’s IncluDE summit. This event drives discussions from industry stakeholders on how to improve diversity equity and inclusion in clinical trials.

There were several take aways that I brought back to my internal team as we focus on ways we can help our Sponsor clients achieve their Diversity Action Plans and support sites in communities with untapped potential to support drug development for a truly representative patient population.

  1. We need bold innovators to move the needle on diversity, equity and inclusion in clinical trials

The evolution of clinical trials and the push for new FDA requirements for Sponsors to submit a Diversity Action Plan for all Phase 3 clinical trials of new drugs, including;

  • Enrollment goals disaggregated by age group, sex, and racial and ethnic demographic characteristics.
  • Rationale for enrollment goals.
  • And explanation of how sponsor plans to meet enrollment goals.

Plans must be submitted but no later than submission of protocol for Phase 3 study (or other pivotal study of the drug.

To accomplish these goals we need innovation through tools, services, and partnerships and improved utilization of patient-focused solutions.

When asked “What patient-facing tools are technologies are improving the overall retention of diverse patients?”

Only 32% of respondents said Virtual visits / telemedicine platform were helpful while the other 78% said No, Somewhat or Not used. Similar results were seen for Community engagement (web-based) and Community engagement (printed materials).

There are two thoughts that come to mind for me seeing these results:

  1. Is technology the best tool for improving retention? We are still caring for people in clinical trials. While offering digital tools can create efficiencies and flexibility, nothing can replace human relationships and having a clinician care for a patient and participant.
  2. How are the printed materials designed and delivered? Did the materials contain diverse patient preclusive language (i.e. language barriers, cultural considerations, etc.)? Where did participants first receive this information and did they receive it from a trusted source?
  3. Improving access to clinical trials doesn’t need to wait until Phase 3, in fact, it may be financially beneficial to Sponsors to act sooner.

More inclusive and diverse trials are driven by making it easier for patients to participate.  This means, designing protocols that have a more flexible schedule, one that doesn’t require the participant to travel to the site for every visit and allows visits to be conducted around their work/personal schedule, and one that is conducted in their own community. The return on investment a flexible trial schedule provides is something we have talked about before in How To Realize The Value of Patient-centric Solutions.  When participation is more attractive, less of a burden, there is a tangible return on investment; patients enrolled are more likely to stay in the study and be engaged in the study.  When a trial is patient-centric, focused on the participant’s experience, this will in turn increase the scientific and financial robustness of the trial1.

I’m on a mission to discover more ways we at MRN can support patients in their health journey and ways we can consult with our Sponsor clients to build patient-centric protocols. At MRN, we are expanding our solutions to reach more patients in more communities around the world.  Pivotal to this is an innovative way of thinking and partnership between industry, sites and patients of every community to achieve diversity, equity and inclusion goals.


  1. Myths about diversity in clinical trials reduce return on investment for industry | Nature Medicine
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