Key metrics for successful D&I in the drug development lifecycle

The healthcare industry still falls short when it comes to health equity. Promoting a culture or supporting a mission that is diverse and inclusive should go beyond hiring practices or using stock imagery of non-Whites in marketing. These practices are good — but they are not enough.

True health equity can’t be achieved until diversity and inclusion (D&I) become forethoughts that shape decisions made at every point in the healthcare journey. One key journey, and possibly the most important, is that of the drug development life cycle, including research, clinical trials and patient education.

Both the public and private sectors have initiated efforts to address clinical trial diversity. The Pharmaceutical Research and Manufacturers of America (PhRMA) announced the release of industry-wide principles on clinical trial diversity in late 2020. More recently, the FDA issued preliminary guidance in the new FDA Guidance Draft (published in April 2022), where companies are encouraged to submit a plan that outlines the operational measures that will be implemented to ensure diverse clinical trial participation (based on age, gender and race) to improve the generation of evidence regarding safety and effectiveness across the entire population.

The industry needs to take a new, strategic approach to D&I and everyone in the healthcare continuum must be an active participant – from practitioners, key opinion leaders (KOLs) and researchers to medical science liaisons and clinical operations. But Medical Affairs teams specifically can be an agent of change.

This effort requires a four-pronged approach with key metrics that includes support from leadership, access to the right data and technology, ensuring diverse trials, and engaging and educating diverse patient populations.

Step 1: Commitment from leadership 

While Medical Affairs can be change agents when it comes to diversity and inclusion in clinical trials and beyond, the efforts must be supported by leadership or they will fail. Large pharma companies are making this a top priority and many have created health equity departments over the past year.

It’s also important to see more diversity among leadership and practitioners. For example, only five percent (5%) of U.S. doctors identify as Black, and the percentage of Black physicians has remained essentially unchanged over the past 120 years. Studies show that racial, ethnic and gender diversity among HCPs improves access to quality healthcare for underserved and diverse populations. In fact, in 2021 the AMA announced a push to improve diversity among physicians.

Once these imperatives are embraced by leadership, they will trickle down to other departments. Insights, engagement, education…it all starts with the right strategy and leadership.

Metric(s):

• How diverse is your leadership team?

• Do you have a plan to improve diversity within your organization?

• Have you committed to having a Health Equity Department at your organization by a certain date?

Step 2: Realize the power of data

The power of meaningful data in the healthcare industry should not be overlooked. A comprehensive and actionable data repository that provides accurate and accessible information about physicians and the populations they serve will accelerate the push toward a healthier and more equitable future.

Today, teams have access to relevant data that was not available a few years ago, such as the race and gender of physicians or demographic makeup of their patients. Medical Affairs teams can use this data to identify and select diverse groups of HCPs and participants for clinical trials.

A purposeful healthcare data platform supports D&I efforts by providing:

• Access to details about every doctor, their industry engagements and the patient populations they serve
• An easily searchable library of the most significant scientific and medical literature around the world
• Insights into both statistical diversity (age, gender, ethnicity) and diversity of thought (advocacy, influence, outreach) in relation to healthcare
• A way to leverage different sets of data to resolve care disparities, such as cross-referencing demographic data with claims and referral data to identify areas with underserved patients

Access to the right insights (via a modern technology platform) will get the industry closer to that holy grail: conducting an efficient, successful and diverse clinical trial.

Related metric(s):

• Do you have a healthcare data platform in place?

• Is the data accurate and continually updated?

• Does it include D&I data?

Step 3: Design trials with diverse patients in mind

Diverse participation in clinical trials is critical to achieving health equity and developing more effective treatments, and it’s clear that people of color are underrepresented in U.S. trials.

According to a 2021 study, less than two percent (2%) of trials over a two-year period had a non-White group as its focus. And among 32,000 clinical trial participants in 2020, only six percent (6%) identified as Asian, eight percent (8%) as Black and 11% as Hispanic. Even the FDA’s own five-year plan to improve clinical trial diversity for Black patients failed, with Black patients still being underrepresented in 85% of all trials and disease categories. The FDA is attempting to address this with their recently issued guidance.

It’s not just participants who should be diverse, but also those running the trials. There is a tendency for Medical Affairs to only target and engage with the “top” academic medical centers and KOLs. However, they often are not representative of the real patient population for a given country or medical condition.

Related metric(s):

• Do the practitioners have experience with diverse patient populations and are they diverse themselves?

• What percentage of trial participants are diverse in relation to total participants (and overall U.S. population)?
• What percentage of non-whites are impacted by the specific condition and are they represented in the trial?

Step 4: Continually engage & educate 

The Covid-19 vaccine brought the failure of U.S. health equity efforts to the forefront, with widespread media coverage that people of color were underrepresented in clinical trials for the vaccines. Medical Affairs’ job is to educate, and clearly there was a gap in educating certain communities.

Medical Affairs must make it easier for diverse patient populations to participate in clinical trials. They can work with clinical trial teams to select sites in underserved communities. Smaller, regional medical centers might be easier for members of underserved communities to visit regularly than prominent national sites that are further away.

Medical Affairs can also work closely with patient advocacy groups (PAGs) to get patients with socioeconomic barriers to take part in clinical trials. PAGs help bring more diverse patient perspectives to the conversation—whether on living with a certain condition, motivating factors for enrolling in a trial in the first place, or how to better empathize with certain populations and meet their needs.

Related metric(s):

• Is the trial site within an X-mile radius of a diverse or underserved neighborhood?

• Is there public transportation available to get to the site?

• Are there other ways to participate in the trial, like virtual, at-home or mobile?
• Are you providing information in a variety of ways – hard copy, via phone, electronic – and are they culturally appropriate?

Health equity is a strategic imperative 

Soon, diversity in the drug development lifecycle will likely be as important as a company’s carbon footprint. There will be specific metrics and goals to ensure the promotion of health equity and diversity not just in clinical studies, but also in education and in the medicines being developed.

Taking steps to eliminate health disparities among people of color and ensuring diversity throughout the development cycle should be a strategic goal for all. The industry as a whole must adopt a “can’t stop, won’t stop” mentality when it comes to achieving health equity. Complacency is the enemy of progress – there needs to be a constant, active push to do better.

Medical Affairs can be the change agents within their organizations to help with this push. Pharma and medical device companies are already starting to make health equity a top priority, and modern technologies and access to reliable data can facilitate Medical Affairs’ role in supporting an inclusive and diverse healthcare ecosystem.

Photo credit: Andrii Shyp, Getty Images

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