Collaborative Initiative Offers Recommendations to Improve Diversity in Myeloma Trials
Posted: Monday, March 8, 2021
Although Black individuals are more than twice as likely as White individuals to be diagnosed with multiple myeloma and to die of the disease, they represent a small proportion of participants in multiple myeloma clinical trials. To improve the diversity of participants in such trials, researchers from Dana-Farber Cancer Institute, the U.S. Food and Drug Administration, and the American Association for Cancer Research (AACR) recently released recommendations for all stakeholders as a road map for designing clinical trials, with the goal of improving the effectiveness of therapies for Black patients with multiple myeloma. The findings of this joint initiative were published in the AACR journal Blood Cancer Discovery.
“If we can make clinical trials more inclusive and representative of real-world patients, we may not only enhance participation of African American patients, but also provide a paradigm for new drug development more broadly,” stated Kenneth C. Anderson, MD, in a Dana-Farber press release.
The collaborative initiative includes a number of recommended changes to the design of clinical trials of drugs for which manufacturers are seeking approval. They include the following steps:
- Broaden eligibility criteria whenever possible. For example, study criteria that reject patients with conditions such as hypertension and kidney disease may disproportionately exclude Black individuals. Including such patients may allow researchers to collect more data in racial and ethnic subpopulations.
- Require trial sponsors to complete a diversity study plan that sets targets for enrolling diverse participants.
- Appoint a diversity officer to assist with trial design and recruitment. Trial design should encompass disease subtypes and features most commonly seen in Black individuals.
Finally, other suggestions focused on the gathering of clinical trial data after approval of an agent. Such post-approval studies may identify differences among racial and ethnic subpopulations with regard to both safety and efficacy.
Disclosure: For full disclosures of the authors, visit bloodcancerdiscov.aacrjournals.org.
