Your clinical research processes are carefully developed over the years, and the success of your project depends on thoughtful preparation. As pharmaceutical companies begin to change their processes to prioritize diversity and inclusion when recruiting study participants, they must be equally thoughtful about finding innovative solutions to increase clinical trial diversity. Not doing so will put studies at risk of delay and could also cause companies to incur monetary or reputational loss.
The conversation around diversity in clinical research has been ongoing for some time, but it’s especially urgent now. Federal guidelines regulating demographic representation in clinical research are evolving, and new FDA guidance documents put any study that’s not suitably diverse at risk of being delayed or rejected.
The consequences of a lack of diversity in clinical trials are growing, and it’s important that pharmaceutical companies become aware of them – and adjust their processes accordingly.
In early 2022, the FDA released updated guidance on diversity in clinical research. Then, in the final days of 2022, Congress passed two laws aimed at boosting clinical trial participation among communities of color.
The Food and Drug Omnibus Reform Act (FDORA Act) introduces several reforms to the FDA, including provisions that encourage greater diversity among clinical research participants. Most notably, the FDORA Act requires clinical trial sponsors to submit diversity action plans for certain late-stage drug trials and most device trials.
As part of FDORA, the Diverse and Equitable Participation in Clinical Trials Act (DEPICT Act) requires trial applicants to submit diversity action plans, as well as enrollment targets by demographic subgroup. It gives the FDA the authority to mandate post-market studies when diversity enrollment targets aren’t met.
Both acts were signed into law in the final days of 2022, and many of their provisions are now beginning to go into effect. Recently, the FDA released draft guidance titled “Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products,” which includes recommendations on standard terminology for the collection of race and ethnicity data in clinical trials and clinical studies.
The arrival of this legislation and updated FDA guidance means that in the future, a lack of diversity in clinical trials will lead to significantly more financial loss than it did before.
If a study doesn’t adhere to FDA guidance, it could potentially be delayed or denied. And as any pharmaceutical developer knows, delays and rejections cost money.
With new diversity recommendations now in place, failing to follow a diversity action plan or meet your demographic enrollment targets could mean slowing down or redoing research, wasting all the money already spent. It also may lead to delays in getting products to market, which again means financial losses as well as disappointed investors.
Alternatively, poor diversity in a trial population could lead the FDA to mandate a post-market research request. This, too, is costly, requiring that you pay for additional research beyond the substantial amounts already spent to bring a drug or device to market.
In the short term, it may appear more expensive to invest in inclusive clinical trial participation. In the long term, though, failing to do so ends up costing drastically more.
There are good reasons Congress and the FDA are focusing more on clinical trial diversity, and key among them is the fact that a study conducted on a homogenous population is simply bad science.
As the U.S. population becomes increasingly diverse, it becomes correspondingly difficult to make the argument that the results of a non-diverse study are generalizable to the broader population. Instead, a study that isn’t diverse may produce results that are skewed or, at best, only applicable to a small percentage of the population.
The consequences of collecting unrepresentative data are well-known. Several studies have illustrated the harms caused by a lack of diversity in clinical trials, including less effective medical interventions, poorer health equity in pharmaceutical practices, billions of dollars in economic losses, and more.
Given that these problems are recognized in the scientific community, any institution that doesn’t take action to diversify research populations may appear to be out of touch with scientific best practices.
Finally, a failure to consider diversity exacerbates the inequalities present in the U.S. healthcare system.
There are countless examples of treatments developed with unrepresentative research that led to poor health equity in pharma interventions. For example, common asthma treatments are often less effective for people with African American or Puerto Rican heritage. Cardiovascular disease interventions were developed based on evidence that primarily featured men, despite the fact that cardiovascular disease is the top killer of women in the U.S. and presents differently in women.
Disparities like these can lead to higher rates of disease and even death for many demographics. These poorer outcomes are compounded by the fact that many underrepresented demographics have little trust in healthcare institutions due to historical lack of respect or access in addition to the lack of diversity in clinical trials.
However, institutions and pharmaceutical companies that are proactive about reaching out to these groups for clinical trial participation can begin to reestablish trust, leading to better health outcomes for them in the long run.
When all factors are considered, it becomes clear that increasing diversity in clinical research is not just a feel-good exercise. It’s necessary for any pharmaceutical company that wishes to get approval for new interventions and compete in today’s market.
Boost inclusivity in trials faster and for the long term by zeroing in on the populations you lack. Acclinate gives you access to communities of color, facilitates engagement around your trials, and then analyzes the data generated to predict and plan where and when your next effort should happen to create the ongoing representation you need. To learn more, schedule a 1:1 Meeting.