Why Drug Approvals and Development Hinge on Diversity

The success of drug development and approval relies heavily on the ability to identify diverse patient populations for clinical trials. From trial site feasibility to successful trial recruitment, diversity within a trial population helps ensure the safety and efficacy of drugs that reach the market.

In this blog post, we will explore how diversity impacts drug development, from pre-clinical stages to regulatory approvals, and what areas medical affairs professionals should consider for increasing diversity of thought from a broader stroke of healthcare providers (HCPs) and key opinion leaders (KOLs).

Begin at the Beginning

A global top 10 pharma company was looking to find healthcare providers (HCPs) with a diverse patient population with Atherosclerotic Cardiovascular Disease (ASCVD), a type of heart disease caused by consistent high levels of bad cholesterol (LDL-C) in the blood that can lead to the buildup of plaque on the walls of the arteries.

When planning a drug development program, it’s essential to consider the diversity of patient populations that will be recruited into clinical trials. This means looking beyond age, gender, and race to include factors such as geography, religious or cultural beliefs, lifestyle choices, health conditions, and socioeconomic status.

By identifying and including diverse trial participants in the clinical trial process from the very beginning, medical affairs teams can ensure that the drug development program is adequately meeting its objectives and helping bring novel therapeutics to market.

For this case study, H1’s unique approach was to: identify national thought leaders in early CKD that have significant scholarship and influence, closing any knowledge gaps that the company might have in their existing thought leader/speaker’s bureau list. Identify those experts that fulfill strategic objectives in CKD, highlighting those with thought leadership, industry engagement, and clinical experience. This kind of insight is critical to finding and deepening diversity of thought among the KOLs, speakers and HCPs that medical affairs teams engage.

Using the aligned methodology, H1 discovered that >80% of the company’s HCPs on its speakers bureau did not meet minimum data thresholds that would make them a strategic fit.

H1 identified 135 experts who fit their strategic priorities, many of whom are not currently engaged, but could be considered for potential engagement. We further highlighted a variety of attributes that these net new experts possess (clinical leaders, allied health professionals, early career, digital leaders) as extra consideration in how they can increase the diversity of thought they retain.

Regulatory Considerations

Just like this company, medical affairs teams must also be aware of any regulatory considerations when planning studies involving diverse patient populations. In some cases, regulatory agencies may require additional data collection efforts or disclosure of trial results when dealing with certain ethnicities or racial groups due to greater scrutiny surrounding drug safety profiles among these populations (e.g., African Americans). It is important for medical affairs teams to be aware of these requirements early on in order to develop effective strategies for collecting additional data points during the clinical trial process if necessary.

In addition to ensuring inclusion of diverse populations in clinical trials, medical affairs teams must also address any potential challenges related to recruitment at trial sites.

Improving Diversity Belongs to Everyone

For example, if a certain population is not represented at a particular site due to economic or cultural reasons, companies should develop strategies for recruiting participants from that population. This could include working with community organizations that can help spread awareness about the research study or partnering with local health centers that cater to minority communities.

Many drugs are being developed for underserved ethnic populations who may not have access to information about clinical trials in their native language. To ensure successful recruitment of these patients into clinical trials, medical affairs teams should consider providing translated materials (e.g., pamphlets and consent forms) as well as bilingual staff members who can explain the details of the research study clearly and accurately in both languages.

Overall, diversity plays an important role in bringing new drugs and treatments to market safely and effectively—from providing access to vulnerable patient populations to addressing language barriers during recruitment processes—making it essential for medical affairs teams to consider how diversity impacts drug development programs from preclinical stages through final approval by regulatory agencies such as the FDA. From leveraging community networks for study promotion efforts to navigating any pertinent regulatory concerns along the way—medical affairs professionals should always take steps towards creating an inclusive research environment when designing their programs from start-to-finish.

To learn more about how H1 can help diversify your HCP engagement strategy, request a demo.