In an incredibly diverse world, health inequities and resulting disparities continue to stand out as a persistent yet addressable challenge. As the global biopharmaceutical industry works to treat, prevent, or even cure diseases, we have a responsibility and unique opportunity to help confront these disparities to make equitable health a reality. One such opportunity is through ensuring diversity of participants in clinical research.
Clinical trials play a critical role in advancing potential new treatments and vaccines to patients. In such trials, we determine safety and efficacy of a given intervention in a given population. Because race, ethnicity, age, and sex can all impact how different people respond to the same medicine or vaccine, it is crucial that the study participants reflect the diversity of the wider population of people expected to receive the treatment. The more diverse a group of trial participants is, the better physicians and regulators understand the risk-benefit balance of a potential treatment or vaccine for the people.
There are things we can and must collectively do as an industry to build a more inclusive future for clinical research.
It is not enough just to increase diversity. To better understand individuals’ health needs and the impact of our medicines and vaccines across all people, research and clinical trials must represent the communities impacted by the diseases we aim to address. For example, one persistent health disparity in the US is that Black women have the highest breast cancer mortality rate of any US racial or ethnic group. If laboratory activities or a clinical trial for a new potential treatment for breast cancer do not study or include an adequate number of Black women, respectively, how can we be reasonably sure that the treatment will effectively combat this disease in this highly impacted patient population?
The importance of this representation is only further magnified when we consider representation of specific groups in clinical research conducted globally. Even though the number of countries participating in clinical trials has almost doubled in the last 25 years, we have not seen a substantial increase in the diversity of clinical trial populations.
Historic mistreatment and human rights violations in research throughout the world have contributed to mistrust of the health system, particularly in populations that have been underserved or underrepresented. A lack of information about and awareness of clinical trials, and time and resource constraints associated with trial participation further compound the issue. These barriers underscore the need for more concerted efforts across our industry to change how we think about and design clinical trials and how we engage and educate the public.
At Pfizer, we are committed to doing our part to deliver breakthroughs for all and are taking decisive steps to do so, such as:
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designing clinical trials so that enrollment reflects the racial and ethnic diversity of the communities where trials are conducted and the epidemiology of the diseases to be treated or prevented;
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building trusted relationships within diverse communities and populations and helping to increase the pool of diverse investigators and trial sites;
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making it easier for patients to find information about our clinical trials and providing culturally relevant materials in a language they understand; and
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expanding our commitment to decentralized trials, which have the potential to reduce the burden on volunteers and increase participation of those who would not otherwise.
No country, entity, or organization can single-handedly solve the challenges of increasing diversity in clinical trials, nor can these changes happen overnight. But there are things we can and must collectively do as an industry to build a more inclusive future for clinical research. Increasing clinical trial diversity is a matter of both good science and equity and must be prioritized to make meaningful steps toward better health outcomes for all.