Unpacking the FDA’s Draft Guidance on Post-Market Data Collection

Over the last year and a half, there has been renewed interest from research sponsors to increase diversity in clinical trials. But what is behind this push and how can it promote health equity?

It has partly been driven by recent laws (i.e., the December 2022 Food and Drug Omnibus Reform Act – FDORA, sections 3601-3604) and regulatory guidance (i.e., the April 2022 FDA Draft Guidance to Industry on Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials) that require submission of diversity plans to the FDA prior to the start of pivotal clinical studies.  

Recently, the FDA published another draft guidance addressing clinical trial diversity to industry, this time, focused on post-marketing approaches to obtaining data on populations who have been historically underrepresented in research.

FDA Diversity Plan: Key Takeaways from the Recent Draft Guidance

1. Pre-market diversity planning is STILL important for inclusive research.

‍The FDA states that plans for including historically underrepresented populations should continue to be made early in the drug development process and that sponsors should consider post-market data collection if it looks like their pre-market efforts will miss the mark. So basically, there must still be genuine, intentional attempts to engage and include diverse communities in earlier phases of research; sponsors cannot solely rely on post-market data collection options nor put forth half-hearted efforts in the pre-market setting. When it comes to diversity planning and execution, sponsors are encouraged to put their best foot forward upfront to recruit for diversity in clinical trials; however, it is ok to pivot and start discussing what post-market data collection could look like if they realize mid-way through their pivotal trial(s) that their best efforts are not enough. The FDA is fine with that and may even consider their post-market data for label inclusion.

2. With appropriate input from the FDA, research sponsors can be thoughtful (and, dare I say, creative) when it comes to data collection.

Regardless of whether the need for data from diverse communities is the result of a post-marketing requirement (PMR - required) or post-marketing commitment (PMC - a written agreement, but not required), the FDA offers a myriad of options for capturing the information. Here are just a few examples of what sponsors may be able to do:

• “Borrow” data from pre-approval studies to obtain a larger sample size of the underrepresented population of interest when evaluating data in the post-market setting.
• Enroll and analyze the underrepresented population of interest in a separate cohort as a parallel arm of the main pivotal trial and continue enrolling even after the primary analysis of that trial is completed if it is determined that more data from that sub-population is still needed. (Sidenote: I really like this approach and remember having many fruitful discussions about it back when I was a Medical Director for a pharmaceutical research sponsor.)
• Stratify according to race, ethnicity, age, etc., so that the data analyses can focus specifically on benefits and risks in the underrepresented populations.
• Leverage real-world data sources (e.g., from registries, electronic health records, and the like) to obtain post-market data, as long as the sources are deemed adequate to answer questions about the underrepresented population of interest.
• Pool data across similarly designed randomized trials to obtain and compare post-market data from underrepresented populations.

There are various study design and statistical considerations laid out clearly in the draft guidance. Research sponsors should feel empowered and motivated to take action on them to ensure communities they’ve historically excluded are represented in their pre- and post-market data analyses to further health equity.

3. Tailored strategies for inclusive research are still needed, even in the post-market setting.

‍The same considerations that are relevant for increasing clinical trial diversity in the pre-market setting are also applicable when attempting to collect post-market data. I’m reminded of the three pillars in our Acclinate Affective Trust Framework for increasing representation in clinical research: (1) Inclusive Study Design, (2) Affective (and sustained!) Community Engagement, and (3) Trust-Enabling Technology. The methods highlighted in our framework for building relationships with historically excluded communities, leveraging culturally tailored communications, upskilling lesser-known research sites, broadening eligibility criteria, expanding digital reach, etc., are important and necessary regardless of whether the research is being conducted before or after a drug’s FDA-approval. There is no need to recreate the wheel, but sponsors should be mindful that each underrepresented population is unique; it is important to start with foundational principles and then tailor their actions to meet the needs of the communities they are aiming to include in their research.    

So, have you read the new FDA draft guidance on post-market data collection in historically underrepresented populations?  What are your thoughts?

Get Support for FDA Draft Guidance and Boost Diversity in Clinical Trials  

Acclinate combines community-building and data analysis to help all of healthcare become more representative, whether the output is researching and developing products and therapies, or creating initiatives that affect historically underrepresented populations. We are not a recruitment company. We are a catalyst that turns trust and data into products that better serve communities of color.

We combine empowered community-building in diverse demographics with data analysis to help pharmaceutical companies actively increase representation in their clinical trials and other health-focused organizations support inclusivity in their initiatives. To find out more about how we can help you prepare for effective post market data collection, book a 1:1 meeting today.