Population Representation: Everyone Must Play a Part

Applied Clinical TrialsApplied Clinical Trials-03-01-2023
Volume 32
Issue 3

The responsibility of increasing diversity falls on every stakeholder in the clinical trial value chain.

The life sciences industry has been talking about improving diversity in clinical trials for years. Historically, this talk has amounted to a lot of hot air. But the situation is urgent: while racial and ethnic minorities comprise nearly 40% of the US population, they only account for 2% to 16% of clinical trial participation. Within oncology, Black Americans constitute around 22% of cancer cases, but less than 5% of trial enrollees. This isn’t just a US issue; globally, 76% of patients enrolled in oncology trials are white. And this challenge exists within a research landscape where nearly 80% of trials fall short of enrollment targets to begin with.

In the aftermath of COVID-19, real change in our industry feels more possible than ever. But diversity is a multifaceted problem—one that we cannot hope to solve with a single solution, action, or actor. The responsibility of increasing diversity falls on every stakeholder in the clinical trial value chain—from technology providers to trial sponsors and CROs; from investigator sites and their staffs to global regulatory bodies—and, maybe most importantly, patients.

Technology companies must commit to developing solutions that are designed for patients’ real-life experiences. To get there, they can’t develop apps in a vacuum; tech companies will have to collaborate frequently with patients and continuously refine their products.

Regulators—both in the US and abroad—must align on guidance that enforces regulations. The EU’s European Medicines Agency (EMA) recently announced new recommendations for implementing decentralized clinical trials (DCTs) with the aim to give a greater voice to patients, and that’s a start. But FDA has issued recommendations around diversity for years yet has rarely taken a hard-nosed approach to enforcement or incentivizing diversity. Globally, there must be harmonization.

Industry associations, such as the Decentralized Trials & Research Alliance, Society for Clinical Research Sites, and the Association of Clinical Research Professionals, also need to come together to collaborate on alignment of recommendations and standards. At Medable, we are actively working with these groups to find common ground on best practices to recommend.

Sponsors and CROs must embrace new approaches and technologies and prioritize investment in them. New DCT models can improve not only diversity but also patient access and trust—improving trials’ overall outcomes. New DCT models must be adopted that may include a hybrid of ways that more patients from more places can access the trial, as well as tools to ease understanding and communications around enrollment, consent, and treatment. In addition to virtual tools, sponsors might also enlist trusted, community-based pharmacies which have partnered with key technology providers to enable community-based trials. These pharmacies also possess data that can help sponsors create appropriate diversity plans for various therapeutic indications.

Investigator sites must consider how their patient interactions and representation of local demographics impact patient trust, recruitment, enrollment, and retention. These front-line clinicians are the boots on the ground and must treat this responsibility in kind, even if it requires additional technology training and more patient hand-holding as the industry evolves and learns.

Patients aren’t off the hook, either. Distrust of clinical research has its roots dating back at least 50 years, to the horribly botched Tuskegee Study of Untreated Syphilis in Black men by the CDC. That history is real and painful—but we can’t let it hold us back in our fight against the world’s most serious diseases. The COVID vaccine trials, while imperfect, made great strides in improving trust among the Black community. We must keep that momentum going. All of us can help through education, evangelization, and active participation in clinical research.

The time is now. The technology is here. The stakeholders are motivated. And there is government backing. In December, Congress approved an omnibus spending package for the 2023 fiscal year that includes riders to improve diversity in clinical trials, as well as increased funding for research and regulatory agencies, including $3.5 billion in appropriations for FDA and $47.5 billion for NIH.

We have all the tools we need to do this right—we just need to work together.

Hady Khoury, chief development officer, Medable

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