The Consolidated Appropriations Act of 2023, which was passed by Congress in the US late in December 2022, contains a number of provisions related to improving representation of minoritised populations in clinical trials. This is BIG news for pharmaceutical and biotech companies, who now must diversify their pivotal and phase III clinical trials. In this blog post, we’ll take a closer look at the clinical trial diversity legislation contained within the act, and why it’s so important for improving health equity.
Summary of the clinical trial legislations
The Consolidated Appropriations Act of 2023 has opened the door to a whole new world for improving clinical trial diversity. This legislation has the potential to reshape the industry and revolutionise our knowledge of human health. From allowing greater access to those in minoritised communities, to providing more overall access to treatments and medications, these measures should provide meaningful impact on many lives. Going forward, these acts will ensure that everyone who participates in clinical trials is treated with fairness and respect for their contribution to research and advancement.
The Diverse and Equitable Participation in Clinical Trials (DEPICT) Act and the Diversifying Investigations Via Equitable Research Studies For Everyone (DIVERSE) Trials Act, calls on pharmaceutical and biotech companies that are receiving grants from the NIH to review their strategies around increasing participant diversity in trials. It’s an exciting opportunity for these life-saving organisations — here’s hoping that they seize it!
In addition to the omnibus, the FDA has been tasked with increasing diversity in clinical trials by analysing diversity plans provided by sponsors, publishing reports to Congress on approved therapies, and holding public workshops. Increasing diversity can be a daunting task, yet the FDA is here to ensure diversity is present across the board in clinical trials. Clinical trial diversity not only helps enrich research methods and outcomes, but it provides patients with treatments that may be tailored specifically for their demographic or background. With the FDA at the helm of this important initiative, we may soon begin to see greater inclusion within clinical trials.
Diversity action plans
One of the biggest changes that the legislation brings into practice is by mandating that pharmaceutical and biotech companies establish a detailed diversity action plan during their phase III or pivotal trials. This plan requires goals for patient diversity, as well as rationales for each of those goals, giving healthcare professionals the data they need to make sure that diversity is considered in every step of the trial process. Without requiring these diversity action plans, clinical trials were at risk of excluding minoritised populations from benefitting from the drugs being researched or tested.
Sponsors will need to submit their diversity action plans to the FDA as soon as possible in order for a phase III or other pivotal study, and any modifications afterwards, to move forward. The FDA may waive the requirement for a plan based on what is known about the prevalence or incidence of the disease or condition at issue, if conducting a study in accordance with a diversity action plan would be unrealist, or if a waiver is necessary to protect public health during a public health emergency.
Diversity action plans will open up an entirely new world of research opportunities for those who were previously unable to participate in drug studies, thus helping encourage medical progress more efficiently and effectively.
The FDA and the public workshops
Community engagement is an essential part of any research efforts that involves minoritised populations. That’s why public workshops that mandate an inclusion of their voices and viewpoints are critical in order for us to develop effective approaches towards establishing a more diverse and equitable environment. This includes careful considerations related to biomarker selection, participant eligibility criteria, collaboration opportunities, as well as ways to ensure fair compensation for frequenting members of such communities. By doing this, we can not only contribute to the development of future scientific discoveries, but also create a society that values everyone.
What should the diversity action plans cover?
There are many areas that need improvement if we are to create equitable clinical trials. Full disclosure, we at COUCH Health provide solutions to support the recruitment of minoritised communities, such as:
- Patient engagement programmes such as community led insights, co-creation of clinical trial materials, the development of lay summaries and more.
- Cultural safety training for sites, through our innovative online platform which supports sites to create their own action plans.
- Local community engagement in key markets such as the US, Latin America and Western Europe.
- Local community hospital engagement to improve and increase referrals.
- Targeted digital marketing.
Why the DEPICT and DIVERSE Trials Act is a boost and a must
The lack of representation among certain groups in clinical trials is a long-standing problem that has only recently started to be addressed by legislative action like these acts. Studies have shown that due to a variety of factors such as socioeconomic status, language or cultural barriers, transportation issues, and lack of access to healthcare insurance or providers, minoritised populations are often excluded when it comes to participating in research studies. This means that drugs and treatments developed based on incomplete data can be less effective for certain populations, simply because they didn’t have the opportunity to be included in the study group used for testing new treatments.
The challenge is how best to diversify clinical trial enrolment without sacrificing scientific accuracy or ethical standards? The answer lies in expanding inclusion criteria beyond what is typically required by most studies today. By broadening inclusion criteria — such as allowing different types of health insurance coverage, providing transportation assistance or phone interpreters if necessary — we can begin to create more representative research studies that ultimately lead to improved healthcare outcomes across all populations.
This blog post has outlined some key elements of the Consolidated Appropriations Act of 2023 related specifically to increasing diversity among enrollees in clinical trials conducted by pharmaceutical and biotech companies receiving NIH grants. It is clear from this overview why increased diversity among study participants is not only good for medical research but also beneficial for improved healthcare outcomes across all populations — especially those who are traditionally underrepresented when it comes to medical research participation opportunities. Moving forward, it will be important for everyone involved, from government agencies and industry stakeholders down to individual patients, to ensure these new laws are properly implemented so we can start seeing real progress when it comes to diversifying our medical research studies. Only then will we see true transformation within our healthcare system.