The FDA’s new FDORA bill includes provisions intended to improve diversity in trial enrolment through decentralised clinical trials and associated digital health technologies. Although far from definitive, the bill sets out the foundations for regulatory alignment both within the US and internationally.

Underrepresentation of diverse populations has long been a challenge in clinical research. It’s a multifaceted issue with modern complexities that compound at various levels of the research process to further prevent participation for diverse communities. The US’s Food and Drug Omnibus Reform Act of 2022 (FDORA) bill is the latest iteration of regulator policy to propose improve diversity, equity, and inclusion (DE&I) in clinical trials. It was part of the Consolidated Appropriations Act, 2023 (H.R. 2617) signed by President Biden on 29 December 2022. The FDORA includes provisions intended to improve diversity in trial enrolment through decentralised clinical trials and associated digital health technologies.

The updated recommendations in FDORA build on previous recommendations and include additional guidance on decentralised clinical trials (DCTs) to ensure equitable access to cutting-edge therapeutics and clinical trials. With this bill, the US also highlights a collective need for harmony with international regulations to facilitate diversity in global clinical research.

Benefits of the plan in action

The FDA is taking steps to improve diversity and standardise the process. The new guidance includes provisions on these key elements:

  • Requirement of robust diversity action plans for all Phase 3 and most device trials (see recent FDA guidance on diversity plans, “Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials Guidance for Industry, DRAFT GUIDANCE April 2022”)
  • Recommendations to reduce patient burden and improve diversity by implementing fully decentralised or hybrid clinical trials
  • Recommendations for digital health technologies and considerations for validating new digital endpoints in decentralised trials
  • Considerations for regulatory clarity and parity across regulatory bodies and an intention to establish international harmony in these areas

Based on what’s outlined in the guidance, some of the positive takeaways are as follows:

Clearing the way for decentralised clinical trials

FDORA provides guidance on and encourages decentralised clinical trials to improve diversity by reducing patient burden and reduce the regulatory ambiguity. Within the US, sponsors have had to navigate the layers and jurisdictions of regulatory oversight that may apply to their decentralised trials. FDORA calls for interaction between different regulatory bodies, specifically regarding the use of digital health technologies and how they interact with various regulations, both internal to the FDA and across HIPAA, Common Rule, and Part 2 to create clarity in the regulatory pathway.

A clearer understanding of this regulatory interplay will facilitate additional decentralisation components to increase diversity and inclusion, specifically by overcoming two common hurdles for patient recruitment and retention: accessibility and convenience. According to a patient voice survey ICON conducted in 2021, 90% of respondents were unwilling to travel more than one hour to participate in a clinical trial. For site-based trials, the physical distance, burden of travel and related financial and time investments exclude significant populations. Providing decentralised options eases the burden of travel and delivers a more positive and convenient patient experience that translates to improved retention. The improved accessibility and minimised burdens allow for increased participation from diverse communities, resulting in more representative trial populations.

More direct data leading to protocol compliance

Supporting DCTs and standardised use of DHTs to support diversity will also positively impact the overall quality of the study. Most notably, we anticipate this enhanced quality through the collation of data directly from the patient. This reduces the risk of missing data, increasing protocol compliance and quality of data. DHTs also alleviate the burden of travelling to a site increasing the options to open clinical trials to diverse patient populations.

Timelines and bottom lines 

Sponsors may be concerned as to how new developments will impact overall timeliness. Additional planning is likely to be required, which we expect will operate in parallel to established trial processes. It is also expected these plans would be submitted along with the other patient facing materials to IRBs.

Additionally, the guidance on decentralised clinical trials will help clarify the implementation processes to streamline start-up. For sponsors, one of the benefits of implementing DCTs is potentially shorter study timelines. These shorter timelines often translate to improved bottom lines. Tufts CSDD found a 10% reduction in clinical trial timelines and increased ROI (average of 6.81) when decentralised methods sponsors applied these approaches across phases 2 and 3.

From grey areas to global agreements

The FDORA bill and the resultant increase in DCTs and DE&I efforts may highlight some ambiguities between this new diversity guidance and the common rule, as well as previous FDA guidelines and guidance regarding data collection using digital health technologies. From a regulatory perspective, one of the operational ambiguities is which body is responsible for the oversight of various elements.

Understanding regulatory landscapes across countries in globalised clinical trials can be challenging in study start-up. FDORA is laying the groundwork for international alignment, however it also recognises the need to work with foreign regulators to facilitate common international standards for DCT and DHT to support innovation in clinical research designs.

Moving forward, together

The call to action to harmonise global regulation will ensure common ground for driving diversity, reducing patient burden in clinical trials, and standardising the ways to achieve those goals. These efforts will streamline the pathways to decentralised clinical trials and use of digital health technologies to support DE&I, resulting in better, more meaningful treatments for the global population.

As FDORA policy recommendations take effect, we anticipate more clarity and unity will develop from the forums and subsequent refinements to the guidance. We are looking forward to continuing to deliver innovative decentralised clinical trial designs and developing more diverse, equitable and inclusive trials

Visit our decentralised & hybrid clinical solutions page to find out more about how to implement decentralised clinical trials and digital health technologies to improve patient centricity or contact us to hear more about how we have delivered diversity in clinical trials for our clients.