The FDA approved 59 novel oncology therapeutics, sponsored by 25 different pharmaceutical companies, between 2012 and 2017. A study by Varma and colleagues reported in the British Medical Journal (BMJ) this month found that only one of these companies included a sufficient number of minority groups in their clinical trials. Just 56% of the sponsors adequately represented women in all clinical trials, and only 24% had a sufficient representation of older adults. Sponsors performed poorly on the inclusion of racially and ethnically minoritized patients, with only 16% of sponsors adequately representing these patient populations. In the study, companies were given a “fair inclusion score”, which was calculated based on transparency (public reporting of sex, age, race, and ethnicity distribution in a trial) and representation. The median sponsor “fair inclusion score” was 87%, with only United Therapeutics scoring at 100%. Seven further companies scored in the top interquartile range: Puma, Sanofi, Takeda, Amgen, Bristol Myers Squibb, Eli Lilly, and Merck KGaA.
Diversity within clinical trials is important for two key reasons. First, it enables an analysis of the safety and efficacy of novel agents in different patient populations, allowing the identification of biological, social, and environmental factors that could affect treatment outcomes. In some cases, this can lead to population-specific information on drug labels, thereby improving safety and efficacy. Second, diversity in clinical trials is essential for equality in the healthcare setting. All individuals should have equal opportunity to participate in clinical research, with this being particularly essential for patients with minimal treatment options for whom clinical trial enrollment gives the greatest chance of disease control or cure.
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Despite US federal government efforts over the last three decades to improve diversity through policy reform, a US Government Accountability Office (GAO) report published in December 2022 found multiple patient groups to be inadequately represented in oncology clinical trials. Numerous barriers to diverse enrolment in clinical trials were identified by the GAO, and these must be addressed for trial equality to be improved. Studies have shown that misconception or assumptions made by healthcare workers about race and ethnicity may impact their decision to mention the option of a clinical trial to the patient. Additionally, mistrust of medical research is more common in certain racial and ethnic groups due to contemporary and historic racism, as well as research misconduct, all of which impacts their willingness to participate in clinical studies. Trial exclusion due to comorbidities such as high blood pressure and HIV infection disproportionally affect some racial and ethnic groups. The location of trial centers may also be a barrier, with patients from underrepresented groups being less likely to receive treatment at large cancer centers. The cost burden experienced by clinical trial patients also deters some underserved populations, with patients having a monthly out-of-pocket cost of over $1,000.
In June 2022, the US House of Representatives passed legislation aimed at increasing trial diversity. This bill will require pivotal and Phase III trial sponsors to submit a “diversity action plan” to the FDA, which must detail enrollment goals according to demographic groups and plans for how these enrollment goals will be met. This federal regulation will force sponsors to address the issue of equality in clinical trials. Methods to increase trial diversity could include having intentional enrollment for under-represented groups and minimal enrollment requirements for each participating center, setting up community trial centers, providing financial support to reduce the cost burden to patients, and providing trial information in an increased number of languages. Trials should also broaden their eligibility criteria so that the trial population can more closely represent the population of patients who will take the drug, if it gains approval. Unfortunately, this federal reform alone may be insufficient to improve trial diversity, as sponsors may fail to actualize the “diversity action plan”. Federal incentives or sanctions may also be required, and could include grants or tax credits for sponsors meeting diversity requirements, or a delay to approval for those failing to meet their targets. The publication of diversity scorecards by the FDA or clinical journals could also increase pressure on pharmaceutical companies to address this inequality and enable clinical trial access for all.
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