When it comes to health equity, the healthcare industry still falls short. The mission of promoting culture or supporting diversity and inclusion should go beyond recruiting practices or the use of non-white stock images in marketing. These are good practices — but not enough.
True health equity cannot be achieved until diversity and inclusion (D&I) becomes a foresight that influences decisions at every stage of the healthcare journey. A critical journey, and probably the most important, is the drug development life cycle, including research, clinical trials and patient education.
Both the public and private sectors have begun to grapple with the issue of diversity in clinical trials.Pharmaceutical Research and Manufacturers Association (PhRMA) Announces Industry-Wide Release in principle About the diversity of clinical trials at the end of 2020.Recently, the FDA has FDA Draft Guidance (Published April 2022), companies are encouraged to submit a plan outlining operational measures to be implemented to ensure diverse clinical trial participation (based on age, gender and ethnicity) to improve evidence on safety and efficacy to generate the entire population.
The industry needs a new strategic approach to D&I, and everyone across the healthcare continuum must be actively involved—from practitioners, key opinion leaders (KOLs) and researchers to medical science liaisons and clinical operations. But medical affairs teams in particular can be agents of change.
This work requires a four-pronged approach that includes support from leadership, access to the right data and technology, ensuring diverse trials, and engaging and educating diverse patient populations.
Step 1: Leadership Commitment
While Medical Affairs can be an agent of change when it comes to diversity and inclusion in clinical trials and beyond, these efforts must be championed by leadership or they will fail. Big Pharma has made this a top priority, with many setting up health equity units in the past year.
It’s also important to see more diversity among leadership and practitioners. For example, only five percent (5%) of U.S. physicians identify as black, and the percentage of black physicians has remained roughly the same over the past 120 years. Research shows that racial, ethnic, and gender diversity among HCPs improves access to quality health care for underserved and diverse populations. In fact, in the 2021 AMA Announce Push for improved diversity among physicians.
Once these imperatives are accepted by leadership, they trickle down to other departments. Insight, engagement, education… it all starts with the right strategy and leadership.
index:
- How diverse is your leadership team?
- Do you have plans to improve diversity within your organization?
- Have you committed to have a health equity unit in your organization by a certain date?
Step 2: Realize the power of data
The power of meaningful data in the healthcare industry cannot be ignored. 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, more equitable future.
Today, teams have access to relevant data that wasn’t available a few years ago, such as the race and gender of doctors or the demographic makeup of patients. Medical affairs teams can use this data to identify and select different groups of HCPs and participants for clinical trials.
Purposeful healthcare data platforms support D&I efforts by providing:
- Access detailed information about each physician, their industry involvement, and the patient groups they serve
- An easily searchable repository of the world’s most important scientific and medical literature
- Insights into statistical diversity (age, gender, ethnicity) and ideological diversity (advocacy, influence, outreach) related to healthcare
- A way to address disparities in care using different datasets, such as cross-referencing demographic data with claims and referral data to identify areas of underserved patients
Getting the right insights (through modern technology platforms) will bring the industry closer to that holy grail: conducting efficient, successful and diverse clinical trials.
Relevant indicators:
- Do you have a healthcare data platform?
- Is the data accurate and continuously updated?
- Does it include D&I data?
Step 3: Design the trial for different patients
Diverse participation in clinical trials is critical to achieving health equity and developing more effective treatments, and it is clear that people of color are underrepresented in U.S. trials.
according to a 2021 Research, over a two-year period, less than two percent (2%) of trials focused on non-white groups. Of the 32,000 clinical trial participants in 2020, only 6% (6%) identified as Asian, 8% (8%) were Black, and 11% were Hispanic. Even the FDA’s own five-year plan to improve the diversity of clinical trials for black patients has failed, and black patients are still underrepresented in all trials and disease categories by less than 85%. The FDA is trying to address this issue with their recently issued guidance.
Not only should the participants be diverse, but so should those who conduct the trial. The Department of Medical Affairs tends to only target and interact with “top” academic medical centers and KOLs. However, they often do not represent the true patient population for a given country or medical condition.
Relevant indicators:
- Do practitioners have experience working with different patient groups and are they themselves diverse?
- What percentage of trial participants were diverse compared to the total number of participants (and the total U.S. population)?
- What percentage of non-whites are affected by a particular condition, and are they represented in the trial?
Step 4: Ongoing Engagement and Education
Covid-19 Vaccine Brings Failure of U.S. Health Equity Efforts to the Fore, Media Covers People of Color Widely underrepresented in clinical trials of vaccines. The job of the Department of Medical Affairs is to educate and there are clearly gaps in educating certain communities.
The Department of Medical Affairs must make it easier for different patient groups to participate in clinical trials. They can work with clinical trial teams to select sites in underserved communities. For members of underserved communities, smaller regional medical centers may be easier to visit on a regular basis than well-known national sites further afield.
The Department of Medical Affairs can also work closely with patient advocacy groups (PAGs) to engage patients with socioeconomic barriers in clinical trials. PAGs can help bring more diverse patient perspectives to the conversation—whether it’s living with a particular condition, the motivators to participate in a trial in the first place, or how to better empathize with certain populations and meet their needs.
Relevant indicators:
- Is the trial site within an X-mile radius of a diverse or underserved community?
- Is there public transportation to get to the site?
- Are there other ways to participate in the trial, such as virtual, at home or mobile?
- Do you provide information in multiple ways – hard copy, phone, electronic – and are they culturally appropriate?
Health equity is a strategic imperative
Soon, diversity in the drug development life cycle could be as important as a company’s carbon footprint. There will be specific metrics and targets to ensure that health equity and diversity are promoted not only in clinical research, but also in education and medicines under development.
Taking steps to eliminate health disparities among people of color and ensure diversity across the developmental cycle should be a strategic goal for all. The entire industry 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, aggressive push to do better.
The Department of Medical Affairs can be a change agent within its organization to help drive this process. Pharmaceutical and medical device companies have begun to make health equity a top priority, and modern technology and access to reliable data can advance the role of the Department of Medical Affairs in supporting an inclusive and diverse healthcare ecosystem.
Image credit: Andrii Shyp, Getty Images
