Effective Oversight to Meet Diversity, Inclusion and Equitable Trial Participation Goals

The Journey

We’ve been on a journey over the past few years to promote Diversity, Inclusion and Equitable participation in clinical trials. Whilst the pharmaceutical industry has made steps towards achieving more representative populations in clinical trials, there is much more we need to do.

The FDA published “Enhancing the Diversity of Clinical Trial Populations” in November 2020, which supported efforts to expand eligibility criteria, improve enrollment practices and trial designs, so that clinical studies would better reflect the population most likely to use the drug if approved.

Roll forward 18 months, and in May 2022 the FDA proposed further guidelines on patient diversity in clinical trials.

The proposed Diverse and Equitable Participation in Clinical Trials (DEPICT) Act further authorises FDA to require sponsors who fail to meet diversity enrollment targets, obtain that data in post-marketing studies.

DEPICT clarifies

• How sponsors should submit a “Race and Ethnicity Diversity Plan” with applications proposing clinical research, or continuing with trials to support the approval of drugs, biologics, and medical devices.
• Sponsors must set enrollment goals for a full range of populations in order to obtain relevant pharmacological and genomic data that can help design larger studies appropriately.
• AND importantly have patient retention strategies, which may involve collaboration with community health workers and patient advocates and reimbursement for expenses to trial participants in need.

To fulfil these goals, access to near real-time data and analytics is more crucial than ever to ensure you are delivering to your plan.

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Importance of delivering to intended plan

Much time is spent in designing the entry criteria to ensure diverse populations in trials and focusing on racial and ethnic diversity planning. But we now need to go beyond an intent and get real about ‘how’ we can make a meaningful difference.

Sponsors are now responsible for identifying and defining potential approaches and solutions to ensure effective recruitment and retention of under-represented participants. Through effective oversight, they need to work with investigators and their research team, clinical sites to establish measures to help ensure accountability. Sponsors must develop and disseminate actionable and scalable solutions to promote the goal of trial diversity in enrollment, and to facilitate subgroup analysis in clinical trials.

What are the risks of not adhering to DEPICT?

It is imperative that robust tools and processes are in place to track and adapt patient recruitment, based on what is happening in reality when study recruitment starts. When sponsors do not meet pre-agreed criteria, the risks are high and may lead to repeating trials in specific subpopulations. This comes at significant cost (tens of millions of $’s), incurring lengthy delays, lost commercial revenue, and MOST importantly, denies patients of potential life changing treatments.

How to ensure effective oversight

The importance of a clinical data platform, such as eClinical’s elluminate^®, can demonstrate to regulators how you, as a Sponsor, will ensure appropriate oversight, and provide reassurance that every effort has been made to meet the desired recruitment goals.

Having access to your operational data will enable your team to focus on the issues that really matter. Using near real-time data analytics and visualisations, will enable you to make impactful decisions at speed. This is especially important when working in an outsourced model, where multiple CTMS are being used, or when using manual trackers.

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Pause for thought

Raising awareness of the importance of diversity, greater corporate responsibility to ensure engagement with underrepresented communities are important to drive change. Regulators expect the broadest and most diverse patient populations to have access to participate in clinical trials. Sponsors must develop, and disseminate actionable, and scalable, solutions or tools, to promote diversity enrollment goals and to facilitate subgroup analysis in clinical trials. Are your oversight tools fit for purpose?

Attending SCOPE US Summit 2023? Make sure to attend our panel discussion ‘Operationalizing Diversity in Clinical Trials: Cross-Functional Capabilities Needed to Recruit, Track, & Adapt for Meaningful Change‘ for more on this topic.