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Increasing JEDI in Clinical Trials

1 March 2022 No Comment
Godwin Yung, Genentech/Roche, and Dooti Roy, Boehringer Ingelheim
The Justice, Equity, Diversity, and Inclusion Outreach Group (JEDI) Corner is a regular component of Amstat News in which statisticians write about and educate our community about JEDI-related matters. If you have an idea or article for the column, email JEDI Outreach Group member Cathy Furlong.

Godwin Yung is a statistical methodologist at Genentech/Roche. As such, he conducts research in survival analysis, adaptive designs, and causal inference; provides consultation for colleagues on the use of appropriate statistical methodology; and contributes to external networks (including ASA JEDI) to further the practice and profession of statistics.

 

Dooti Roy is a global product owner and senior principal methodology statistician at Boehringer Ingelheim. She enjoys developing/deploying innovative clinical research and statistical visualization tools and has expertise in creating dynamic cross-functional collaborations to efficiently solve complex problems. She leads two global, cross-functional product teams.

 
Statistical practitioners in the biopharmaceutical area gather at the ASA Biopharmaceutical Section Regulatory-Industry Statistics Workshop (BIOP) every September to engage in conversations about contemporary topics of importance. Having heard the health disparities taking place in the ongoing COVID-19 pandemic and being industry statisticians ourselves, we decided to host a roundtable at this year’s conference on increasing JEDI in clinical trials—a related but wider topic. We even had two experienced US Food and Drug Administration (FDA) members join us: Rear Adm. Richardae Araojo, associate commissioner for minority health and director of the Office of Minority Health and Health Equity, and Mark Rothman, director in the FDA’s Division of Biometrics II. Here are three key takeaways from our conversation.

First, from drug discovery to reimbursement, JEDI is a critical problem at every step of the drug development process. For instance, 8 percent of the global population represents more than 90 percent of genomic databases and 80 percent of clinical research participants. This pulls into question whether the drugs discovered, developed, and approved benefit the general population of patients similarly. In addition, psychosocial distress, difficult therapeutic regimens, lack of time, residence instability, and lower socioeconomic status can be barriers for retention. And while spending on medicine is a concern across all countries, it is a particularly challenging issue in low- and middle-income countries where it accounts for more than 70 percent of total health care expenditure.

Second, sustainable solutions begin with a deeper understanding of diverse patient perspectives and experiences. Araojo highlighted efforts at the FDA Office of Minority Health and Health Equity, including the Enhance EQUITY Initiative that seeks to increase equitable data efforts and amplify FDA’s communication with diverse groups. He also mentioned challenges to JEDI are multifactorial, including lack of minority investigators, language barriers, transportation, lack of access, not knowing what trials are out there or awareness about clinical trials, and inability to take time away from jobs or caregiver responsibilities. Consequently, cross-functional collaboration is critical. Only by working with our colleagues from clinical operations, ­sourcing, and staffing; site selectors; site monitors; and investigators can we influence and make change.

Third, as stewards of data and key contributors to drug development, statisticians can play a major role in the understanding and proposal of solutions to JEDI. Perhaps a first step for all of us could be to look at our own work with “JEDI goggles” and ask the question, “How might my activities, interests, and spheres of influence be related to JEDI?”

FDA publishes drug trials snapshots on their website, which satisfies a congressional mandate and provides consumers and health care professionals with concise information about who participated in clinical trials that supported the FDA approval for new molecular entities and original biologics. Drug trials snapshots make demographic data available and transparent, as well as highlight whether there were differences in the benefits and side effects among demographic groups or any other important factor.

The FDA has also cosponsored symposia and workshops on heterogeneous treatment effects, considering solutions to new questions about providing the best information to consumers and patients about what benefits and side effects they may expect for a product. Addressing such questions provides opportunities for statisticians to have a larger impact on public health.

We are now onto next steps, trying to learn more while identifying concrete ways in which we, as industry statisticians, can contribute. We invite others across all sectors to do the same.

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