Despite a clear scientific and commercial imperative, a significant gap between patient and trial populations persists. We explain why diversity in clinical trials matters to investors and explore our engagement with companies.
Diversity in clinical trials is, first and foremost, a scientific imperative, but also increasingly a regulatory and commercial requirement. A trial population that represents the diversity of the target patient population is important for the full evaluation of safety and efficacy and building patient trust. However, for various operational and historical reasons, it is rarely straightforward to achieve. As investors, we are interested in assessing strategic thinking, action and progress on this topic across the sector, and encouraging improvements. Considerable groundwork is needed to enable greater trial diversity, and a failure to take timely steps risks delays and additional cost to drug development, which may impact commercial success.
Why trials matter
Clinical trials are designed to evaluate the effect of interventions (such as drugs, devices, surgeries and diets) on health-related biomedical or behavioural outcomes.1 To account for different genetic, (patho)physiological traits, as well as social determinants of health, it is important to include people that account for diverse traits and circumstances in clinical trials and reflect the epidemiology of the disease. As an example, women of colour are 41% more likely to die of breast cancer than white women, and they have a 39% higher recurrence rate.2 However, for four new breast cancer treatments that were approved by the Food and Drug Administration (FDA) in 2020, black clinical trial participants only made up 2-9% of clinical trial participants.3 Of the 53 novel drugs approved in 2020 by the FDA, 75% of trial participants were white, whereas 40% of the US population is comprised of minority racial and ethnic groups.4&5
Gaining a full understanding of the safety and efficacy of novel therapies across all demographics can only be achieved when clinical trial enrolment is representative.6 When companies are able to better identify safety issues for certain populations prior to market entry, this can limit financial and legal risks resulting from product recalls and patient litigation.7 Upcoming regulatory requirements will push the industry to include diversity planning in their trial protocol or justify why this is not necessary. Being unprepared for this might result in novel drugs and therapies not being approved by the FDA, which poses a very material risk to drug manufacturers and Contract Research Organisations (CROs).
In addition, we consider improving diversity in clinical trials as an opportunity for the industry to enhance trust-building with current and future patients. As trust in the pharmaceutical sector is a persistent issue that also affects drug and vaccine uptake, trust-building has the potential to have a much wider effect on pharmaceutical companies. Studies find that higher levels of trust among disadvantaged communities can be expected to contribute to better health outcomes for their members, and can drive, in turn, a virtuous cycle – from higher-quality data to more expansive problem solving to better-targeted approaches, and to greater collaboration throughout the healthcare ecosystem.8 This will ultimately be beneficial for the industry itself as higher trust will most likely also positively impact areas other than clinical trials – for instance, drug and vaccine uptake.
Interested in learning more?
We discuss why this is material for investors and what different barriers exist to diversifying clinical trials. We also explain how we engage investee companies on this topic and which good practices we have identified from this. Download the full ESG Viewpoint to learn more.