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    The 5-Minute Guide to FDAISA Section 907, the FDA’s Patient Diversity Initiative

    By Hannah Drake • October 15, 2020
    5 Minute Guide to FDAISA Section 907

    The best way to ensure new medical treatments are safe and effective for everyone is to include as diverse a population as possible in clinical trials. Unfortunately, this has been challenging for a myriad of reasons, which we’ve explored in our white paper, “Ending Racial Disparities in Clinical Trials." In 2012, the U.S. government set out to address the situation by including Section 907 in the Food and Drug Administration Safety and Innovation Act (FDASIA) 

    Section 907 directed the FDA to find out how well demographic subgroups (sex, age, race, and ethnicity) were being represented in clinical trials for medical treatments and devices. It also directed the agency to determine how well data regarding the safety and effectiveness of medical products among these demographic subgroups was being reported to the FDA and to the public.  

    In 2013, the FDA issued its report on its findings, and noted that most drug and device manufacturers were already including age, gender, and racial data in their applications for product review and that FDA was sharing it “in a variety of ways.” However, whites continued to represent a disproportionately high percentage of clinical trial participants, while Blacks, Hispanics, and Asians were underrepresented.  


    After holding public hearings for additional input, the FDA released its action plan in August 2014. The plan outlined a three-step approach, focused on . . .

    1. Improving the quality of data collection, reporting, and analysis among demographic subgroups;
    2. Identifying barriers to participation by demographic subgroups, and taking steps to address them; 
    3. Making information about safety/effectiveness among demographic subgroups more available, understandable, and transparent.  

    The first step relies heavily on the FDA providing additional training to its reviewers and other staff. It also recommends that sponsors enhance the demographic information they include in applications for product reviews.  

    The third step will be addressed through strategies like improving the quality of written communications about medical products, especially for people with low health literacy or for whom English is a second language. The FDA also plans to expand the number and type of channels through which it will communicate such information.  

    The second step is perhaps the most complex. Barriers to participation include lack of transportation, insurance status, scheduling conflicts, and lack of awareness in general about clinical trials. In addition, many minorities have a deep-seated mistrust of clinical trials, based on historical episodes of discrimination and abuse in research. (For more on this, read “How Clinical Trials Have Institutionalized Racism in Healthcare and How We Can Address It.”) Furthermore, the FDA’s action plan includes rather vague objectives like forming a working group “to explore educational tools and outreach mechanisms to more broadly engage subgroups.” 

    Industry often moves quicker than government and tackling the problem of racial disparities in clinical trials is a case in point. Our latest initiative at par8o—the par8o Research Network (PRN)—is designed to make a big dent in racial disparity in clinical trials by connecting America’s health centers and their patients with appropriate clinical research opportunities.  

    Patients who receive primary care at a community health center or federally qualified health center reflect considerable racial and socioeconomic diversity. Of the 29 million Americans who used health centers in 2019, approximately 36 percent were Hispanic/Latino and 22 percent were Black. More than 90 percent were at or below 200 percent of the federal poverty level.   

    PRN can help health centers identify patients who both meet eligibility criteria for local studies and would benefit from participation. Par8o technology makes it easy.  

    We are proud to report that PRN is at work right now helping to improve efficiency and equity in research and healthcare, particularly for the benefit of those who have too often been short-changed by the system.