True voices

Inclusive approaches to diversity and inclusion.
How can we move from awareness to action?

In meeting rooms around the world, discussions are taking place that examine what can be done at strategic, protocol, trial site and patient levels to ensure accelerated clinical trials yield successful drug development in rare diseases. Historically, these conversations have not included the patient voice, particularly representative and diverse voices.

ICON is committed to advancing diversity and inclusion in clinical trials in partnership with sponsors and other clinical research stakeholders. We believe that when done well, patient advocacy and Diversity, Equity and Inclusion (DEI) are similar in that they focus on moving people with expertise borne from lived experiences from the margins of partnership and decision-making to the centre.

Patients advocate for, take and benefit from the therapies being developed. They are the end user, and therefore should be considered a key stakeholder in the drug development process. This is best expressed by the patient advocacy community itself in the slogan: ‘Nothing for us without us.’

Moving the dial

At ICON, we see a number of key actions that can help when it comes to increasing diversity in clinical trials.

Be accountable. Measurement is the alpha and the omega in drug development. What gets measured, gets done. If companies want to demonstrate an authentic commitment to DEI, there needs to be a measurable system for accountability.

DEI and patient engagement must not be relegated to token objectives that are arbitrary or optional. Incorporate DEI and patient engagement into company objectives with performance metrics tied to those objectives. Until there is an incentive to make DEI actionable, it will be hard to deliver real progress.

Be aware of and challenge presumptions and assumptions. Test the validity of assertions about barriers around clinical trial participation by engaging a variety of patients and advocacy leaders who can verify or dispel potential misunderstandings.

For example, in some patient communities there may be hesitancy to participate in clinical research because of Tuskegee and Henrietta Lacks, but there are also many people who want to participate in clinical research who are never given the opportunity, or because of various barriers – language, cultural, geographic, financial etc.

One direction

If the presumption is that one voice or one experience is all experiences, and this is not challenged, the industry has done a disservice to the entire community. Therefore, it is incumbent to include diverse and representative voices into discussions to ensure assumptions are not heralded as fact until they are validated as such with patients.

Access existing talent and resources. Build well-resourced patient advocacy teams that can connect to diverse patient voices and insights. Partner with health equity advocates to ensure historically underserved communities are engaged in culturally competent and impactful ways. Invest in clinical trials sites located in traditionally underserved areas or innovate to decentralise trials and make them more accessible to participants.

Tap into myriad webinars, seminars, panels, podcast and platforms created by leaders in the DEI space. There is no lack of resources instructing individuals and companies on how to effectively engage diverse and representative patient voices.

Among these offerings is ICON’s Patient-Centric Drug Development Toolkit that includes DEI considerations to encourage and promote representation in clinical research. ICON’s Centre for Rare Disease also hosted Beyond Buzzwords, an interdisciplinary panel of experts who provided insight on systemic and individual barriers to DEI in clinical research and how to solve for those barriers.

Despite myriad resources available, there is no action without acting. Ultimately, moving from awareness to action in DEI begins as simply as just doing the work.