With the DEPICT Act, trial diversity is no longer a “nice to do.”
But new approaches are required to make it real.
The recently passed DEPICT Act creates the first-ever national standard for diversity in clinical trials, with the aim of ensuring racial and ethnic minority groups are better represented in the study of experimental medicines. It mandates data reporting for late-stage studies on participant demographics. Sponsors will be required to report – and to defend – the rationale for enrollment targets by demographic.
They’ll also be required to detail the outreach and engagement strategies that will enable them to reach these enrollment targets. The consequences for failing to miss enrollment targets can be significant; the FDA is now empowered to mandate post market studies where they aren’t met.
Our take? Study diversity is both a moral AND medical imperative. When only 25% of clinical study participants are non-white (as was true for drugs approved in 2020) and the vast majority of participants are highly educated, it’s impossible for the FDA and clinicians to fairly evaluate safety and efficacy of new therapeutics for the more diverse populations they’re intended to treat. It’s about being commensurate with the burden of disease.
But most study sponsors have been long aligned – and publicly committed – to diversity goals. The problem is they simply haven’t figured out how to meet them.
With the FDA increasingly indicating it wants sponsors to consider diversity planning before their first point of contact with the agency, before a drug ever enters the clinic, one thing is clear: the traditional recruitment approach of relying largely on academic medical centers will simply no longer work.
Instead, study sponsors will need to actively and directly reach patient communities that better represent the burden of disease with information about their studies and the value of enrolling.
They’ll also need to find a way to build engagement and trust, and to catalyze patients to take action… overcoming mistrust and educating patients about the role and value of clinical studies in advancing new treatments, as well as potential patient benefits, and making it easier to participate in studies through digital health innovation and trial decentralization.
Ultimately, they’ll need to find a way to do it cost effectively; a high cost burden—especially on small companies—may reduce their ability to bring forward new innovation, an unintended but potentially devastating outcome.
At ENTENTE, a sister agency to Affinity Strategies, we’re working to bring together expertise in behavior science, strategic communications and integrated marketing to help sponsors meet and exceed clinical enrollment and retention goals.
Our programs reach and engage diverse populations using culturally relevant, integrated, relationship-based communications and education. We go where patients and the influential people in their lives are and study their journeys – from diagnosis to treatment. And we tailor language to their needs and preferences, working under a culturally responsive model to provide resources they need for better informed decision-making. We also train investigators and sponsor leads to connect with diverse audiences using jargon-free, responsive language.
We also believe strategic partner networks are needed to maximize reach, amplification and influence. Professional associations and advocacy organizations have an important role to play in ensuring clinical trial diversity and continued innovation for the patients they and their members help serve! They can:
- Partner to provide access to patients and clinicians for behavior journey studies.
- Educate their members about new trends, including decentralization and digital health innovation, and
- Partner to provide culturally responsive communications training and materials specific to more diverse clinical study participation.
Ultimately, codifying recruitment standards is a good start to advancing study diversity; standards catalyze action and enforce change. But it will take new thinking, new approaches and new collaborations to really make it happen.
How we expect clinical trials recruiting to change with the passage of the DEPICT Act:
1. Innovation in direct-to-patient recruiting strategies.
2. Enhanced use of digital technologies — and with them a continued shift toward culturally specific language and user interface — enabling decentralization of trials
3. Increased demand for cultural responsiveness among trial investigators and staff.
Virginia Amann is CEO and Founder of ENTENTE Network of Companies, encompassing communications consultancies including ENTENTE Health & Science, ENTENTE Health & Hospital and ENTENTE Behavior Science, as well as the media group ENMedia.