Project Equity – Get Prepared 

Project Equity – Get Prepared 

Project Equity – Get Prepared | Blog Post – In 2013, the FDA published a report that reviewed clinical trials for seventy-two drugs, biologics, and Class III devices approved by the FDA in 2011. The report showed that while some sponsors were able to recruit subjects that accurately reflected the distribution of the disease in the population in terms of age and sex, the studies did not reflect participation by racial minorities and socially disadvantaged subgroups within the disease population. These results led the FDA to drive several initiatives to address diversity in clinical trials, the first of which was to issue a guidance in 2016 entitled Collection of Race and Ethnicity Data in Clinical Trials. 

In 2017, the US Congress enacted the FDA Reauthorization Act of 2017 (FDARA), which required the FDA to enhance diversity in clinical trials. As a result, the FDA published a guidance in 2020, Enhancing the Diversity of Clinical Trial Populations. 

Project Equity is an FDA Oncology Center of Excellence Initiative that aims to ensure that data submitted to the FDA for approval of oncology medical products adequately reflects the demographic representation of patients for whom the medical products are intended.  

The Food and Drug Omnibus Reform Act (FDORA) was signed into law in December 2022. This law includes provisions for clinical trial diversity and modernization. The requirement to submit Diversity Action Plans applies to Phase 3 and other pivotal clinical studies of drugs, biological products, and devices. One of the provisions of the Act was for the FDA to issue draft guidance on diversity action plans. 

In April 2022, the FDA issued a draft guidance encouraging sponsors to submit Diversity Action Plans that help ensure the adequate participation of relevant and underrepresented populations in clinical trials. This guidance expanded on the 2016 FDA guidance, and submission of the diversity plans in accordance with the draft guidance has been voluntary so far.  

Since the draft document was in effect, the FDA has reviewed plans and received comments from sponsor companies. Between April 13, 2022, and April 13, 2023, the Oncology Division received 76 Diversity Plans from 42 unique companies, and the Division provided feedback on 31. Additionally, the FDA has received 105 comments from the Industry on the draft guidance. FDA is working hard to ensure that the final guidance addresses comments and concerns and provides needed clarifications. 

While we wait on the final guidance, the Industry needs to prepare now for when the guidance becomes final. Once the final guidance is issued, the requirement to submit Diversity Action Plans will apply to clinical studies that commence after the date, which is 180 days after the publication of the final guidance. This may seem like a long time, but it will go by quickly.  

All sponsors and CROs must keep this new requirement at the top of their minds when designing and implementing new clinical trials. These plans take time to develop, requiring protocol design and operational considerations. While big pharma has been an early adopter of these concepts, small biotech needs to consider them in their development plans. 

Diversity for pivotal trials is a challenging concept within the oncology space because racial and socioeconomic distribution differences within the disease population can make recruiting at major academic centers of excellence difficult. Furthermore, as we see more and more drugs approved through seamless design trials and accelerated approval processes, the need for diversity planning will be pulled into successively earlier phases of research. 

But there are actions that the Industry can take—and that sponsors can document in Diversity Action Plans—to reach these parts of the disease population. The major advantage to committing to Diversity Action Plans is not just compliance with future FDA regulations but rather ensuring the intrinsic validity of the study, thereby ensuring more accurate marketing claims. Enrollment into many oncology trials within specific populations can seem hard enough, but with the right strategies, commitment to diversity does not need to hamper enrollment goals. 

OncoBay Clinical has helped biotech clients drive Diversity Action Plans and take actions to enhance diversity in their clinical trials to meet project equity requirements.

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