Preparing for New FDA Diversity Action Plan Requirements in Clinical Trials

Decentralized clinical trials can help increase participant diversity while improving product development and safety

Improving diversity in clinical trials can help tech and life sciences companies capture the data they need to develop more effective products and targeted therapeutic interventions — but ensuring participant diversity will soon also be required for many clinical trials. In April 2022, the Food and Drug Administration released a draft of its "Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials Guidance for Industry," which recommended diversity action plans. Public Law 117-328, which went into effect December 2022, now requires FDA to update their guidance to require diversity action plans for some clinical studies related to applications for new drugs or medical devices.

Despite benefits such as ensuring broad health and safety among the populations expected to use a medical intervention, opportunities for innovation, and increasing equity, FDA reports a substantial lack of diversity in clinical trials. For example, in 2020, Black or African American, Asian, and Hispanic trial participants only accounted for a combined 25% of trial participants among all new molecular or therapeutic biologics approved that year. 

As companies grapple with new regulatory requirements and significant potential to improve the development and effectiveness of various medical products, successfully implementing a diversity action plan may require a very different approach to conducting clinical trials than traditional strategies — one that is much more patient-centric and significantly reduces the burden on participants. 

Decentralized clinical trials (DCTs) offer pragmatic options for improving participant diversity while capturing valuable, high-quality, real-world, real-time data. By leveraging electronic communications and digital health tools to replace site visits, DCTs bring clinical trials to the participants, making participation less burdensome and more accessible to relevant populations. With proper execution, DCTs can improve recruitment and retention, shorten study durations, and lower costs.

Advantages of decentralized clinical trials

Traditionally, clinical trials have been conducted using a complex infrastructure of in-person sites, like hospitals or clinics, with varying levels of technology integration and extensive manual processes. Complexity in trial design can lead to a very poor experience for participants who must travel to a centralized site. Recent estimates indicate that 70% of potential trial participants live more than two hours away from a study center, up to 86% of clinical trials do not reach recruitment targets within specified periods, and the average dropout rate across all clinical trials is 30%.

DCTs seek to make trials faster and improve the participant experience by bringing trial activities to the patient, rather than the opposite. While certain elements of clinical trial decentralization existed before 2020, the COVID-19 pandemic significantly accelerated the adoption of DCTs, with an increase in trial activities conducted remotely and in participants' homes.

Several benefits can be expected from continued adoption of DCTs, including:

• A wider recruitment target population through elimination of barriers related to transportation, patient and provider logistics, and geography. 
• Trials designed to address underrepresentation in important subsets of a study population, including those disadvantaged by frailty, healthcare access, or social or structural inequity.
• Utilization of recruiting teams beyond the conventional clinical setting with grassroots approaches, such as incorporating trusted community partners to recruit underrepresented racial and ethnic populations as well as rural and underserved populations. 

Collectively, these benefits may lead to lower attrition and higher participant engagement, which can improve study participant experience, lower costs, and shorten study duration.

Challenges of decentralized clinical trials

While DCTs promise multiple advantages over conventional clinical trials, decentralizing clinical trials is neither simple nor easy. DCTs require a robust, secure, and sophisticated digital technology infrastructure suitable for the specific study objectives and patient populations. DCTs must meet the same regulatory requirements as conventional trials plus additional requirements to ensure the quality, accuracy, and integrity of data collection, storage, and transmission. Therefore, DCTs need to provide high-quality logistical and IT support.

The clinical trials team should also receive formal training on relevant cultural issues and strategies to facilitate the recruitment of underrepresented populations; successful recruitment and retention of diverse populations may be enhanced if the team displays a similar level of diversity. The remote nature of DCTs requires participants to be more self-motivated and engaged, which requires careful patient selection and engagement strategies tailored to diverse populations.

Technology and communications are crucial

DCTs range from fully decentralized, where all trial procedures are conducted remotely, to hybrid, where, for example, an initial on-site visit is followed by remote procedures, which may be supplemented by mobile clinicians for subsequent person-to-person procedures. With proper training, changes in weight and vital signs such as body temperature, pulse rate, respiration rate, and blood pressure can be monitored and recorded remotely by the participant. More specialized procedures, such as a blood draw for lab tests or injections, can be performed on-site or by a mobile clinician in the participant's home.

Whether fully decentralized or hybrid, DCTs require digital health technologies and remote communications to operate effectively and achieve expected advantages over conventional clinical trials. DCTs depend on technologies, such as eConsent, telemedicine, mobile health applications, remote monitoring, and electronic data capture. Ensuring the privacy and security of the data collected, stored, and transmitted requires adherence to regulatory requirements and best practices in data security.

However, digital health technologies don't replace the human communications necessary for successful patient-centric clinical trials. Personnel are required throughout the DCT process to recruit participants, educate and train them, and ensure retention through ongoing communications. Personnel are also needed to monitor the quality, accuracy, and completeness of the data collected. It is especially important to combine communications technology that can reach a broad pool of diverse participants with a research team's cultural knowledge and willingness to create customized outreach strategies for racial and ethnic minorities and other underrepresented populations.

Compared to conventional clinical trials, DCTs can enable faster participant recruitment, improve participant retention, and significantly increase the diversity of the enrolled population, especially those previously underrepresented. This can lead to a more representative study population and more generalizable study results. But to achieve these advantages, DCTs must combine technological, logistical, and research team expertise beyond that traditionally required for conventional clinical trials.