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.
05.01.2024 | 07:22 Uhr
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. 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.Why trials matter
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.
2https://touchbbca.org/blackdatamatters/
3https://www.breastcancer.org/treatment/clinical-trials/diversity-in-trials
4https://www.thelancet.com/journals/langas/article/PIIS2468-1253(21)00228-4/fulltext
5https://www.fda.gov/media/145718/download
6https://www.thelancet.com/journals/langas/article/PIIS2468-1253(21)00228-4/fulltext
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