Is Clinical Trial Diversity the New Patient Centricity?

This blog was authored by Alicia Staley. Alicia is the VP of Patient Engagement at Medidata and leads Medidata's Patient Insights Board.

For the past 10 years, no phrase in the clinical trial industry has been overused more than “patient centricity.” Until today. Go to any conference and you’ll see that the new buzzword phrase is “clinical trial diversity”.

The Oxford dictionary defines diversity as, “the state of being diverse; variety” and “the practice or quality of including or involving people from a range of different social and ethnic backgrounds and of different genders, sexual orientations, etc.” In clinical trial “speak,” diversity is often reduced to the inclusion of people of color.

Simply put, clinical trial diversity cannot and should not be reduced to a check box.

But how can we make clinical trials more diverse in an environment where it’s too easy to revert to the way things have always been?

In late 2020, the Food and Drug Administration (FDA) issued guidance on “Enhancing Diversity of Clinical Trial Populations” and offered several approaches for drug developers to consider, including:

• Making trial participation less burdensome for participants
• Improving patient awareness and recruitment
• Expanding access

Many in the patient engagement space will tell you that the documentation of these recommendations is a good step in making change. But those brave enough to speak up will tell you these recommendations are what we’ve been saying for decades.

What is needed now is an actionable plan that sponsors and CROs can employ to make sure that clinical trials are fit for purpose, or dare I say it, fit for service. Service to the individuals who volunteer to take part in the only method to ensure that new medicines, vaccines, and devices make it to market.

Improving Clinical Trial Diversity

We’ve identified 5 key areas of improvement for clinical trial teams to employ:

1. Build patient trust: Educate, empower, and engage patients before a trial even begins.
2. Rethink inclusion/exclusion criteria and study designs: Design trials that mirror the population that will benefit from the approved medicine, vaccine, or device—not the perfect patient who exists only on paper. Employ decentralized clinical trial (DCT) capabilities as appropriate and give patients a choice in how and where they participate.
3. Evaluate site selection: Use benchmarking to inform site selection, but not define it.
4. Support patient recruitment by treating patients as people, not as a commodity.
5. Continue to collect diversity data: make sure sites/trials continue to collect and report demographic/diversity data to help inform future research

Patient centricity is defined as “putting the patient first in an open and sustained engagement of the patient to respectfully and compassionately achieve the best experience and outcome for that person and their family.” At its core, diversity in clinical trials is not so different, as it makes sure that clinical research includes a diverse range of participants that reflects the broader population. Diversity, inclusion, and patient centricity cannot be another “check box” to address in clinical trial design.

Diversity in clinical trials is critical for advancing equity and access to ensure everyone receives appropriate and effective medical treatments. Technology can play a vital role in increasing clinical trial diversity by facilitating patient recruitment and retention, providing better access to healthcare, and promoting patient engagement. By leveraging technology to address disparities in clinical research, we can ensure that all individuals have equal opportunities to participate in clinical trials and benefit from the latest medical advancements. It's essential to continue exploring and implementing technical solutions to improve diversity in clinical trials and ultimately improve healthcare outcomes for all patients.