Decentralized Clinical Trials (DCTs) are increasingly recognized for their potential to enhance patient diversity and access in clinical research. However, recent studies indicate that the impact of DCTs on diversity is nuanced and that these trials also introduce unique challenges, including potential research misconduct risks.
Diversity and Decentralized Solutions
Data from a 2023 study by the Center for Information and Study on Clinical Research Participation (CISCRP) involving 11,235 global respondents indicates that while most participants across racial and ethnic groups view DCT solutions favorably, concerns exist. Between 90% and 95% of Asian, Black and African Descent, Hispanic and Latino, and White respondents considered in-person, remote, and virtual study visit options “very” or “somewhat” important. These options include televisits, home visits, local and specialty labs, and wearable and mobile devices. Comfort levels with remote solutions were high (70%-85%) across groups. However, 50%-60% of respondents, particularly those identifying as Black and of African Descent, worried that DCT solutions might compromise privacy and diminish relationships with study staff. A significantly higher percentage of Hispanic and Latino patients (43%) were concerned about increased data plan costs.
A Tufts Center for the Study of Drug Development (Tufts CSDD) study further explored the association between DCT use and patient enrollment diversity. The study, which analyzed 950 protocols from 16 pharmaceutical companies and contract research organizations (CROs), found that the impact on diversity varied depending on the specific decentralized solution used.
Measurable Associations in Patient Demographics
The Tufts CSDD study evaluated 331 protocols using DCT solutions with available participant demographic data, primarily Phase II and III studies. The protocols were nearly evenly split between small-molecule therapies and biologics, with immunology, rheumatology, and oncology being the most common therapeutic areas. On average, 52.9% of participants were male. The majority of enrolled patients were White (73.5%), followed by Asian (15.9%), Black and of African Descent (9.8%), and Hispanic and Latino (12.7%).
The results indicated that clinical trials using one or more DCT solutions had a lower percentage of White participants (72.7%) compared to trials without DCT solutions (81.3%; p = .0455). However, the use of virtual or televisits was associated with a significantly lower percentage of Black participants (5.5%) compared to trials without these solutions (11.4%; p = .0023). No significant differences were observed with mobile or wearable devices. Trials using local labs showed a significantly lower percentage of White participants (p = .0354).
Underlying Factors Influencing Diversity
The study suggests that the convenience of local labs, reducing travel burden while maintaining in-person interaction, may contribute to a more diverse mix of study volunteers. Conversely, virtual visits and televisits require technology and infrastructure that may not be readily available to underserved communities, potentially explaining the lower enrollment of Black participants. The location of research centers and the willingness of patients to travel more than 20 miles have been shown to significantly influence clinical trial participation.
Research Misconduct Risks in DCTs
While DCTs offer numerous benefits, they also present unique risks for research misconduct. The decentralized nature of these trials increases the number of data entry points, raising concerns about data falsification and fabrication. The complexity of DCTs can also make it more difficult for principal investigators (PIs) to exercise adequate oversight, particularly with remote sub-investigators and healthcare providers (HCPs).
Data integrity concerns are amplified by the challenges of obtaining data from multiple sources, some of which may be less sophisticated. To address these risks, the Office of Research Integrity (ORI) has revised regulations to modernize oversight, including designating a lead institution in multi-institutional allegations.
Mitigating Research Misconduct Risks
To mitigate research misconduct risks in DCTs, PIs should prioritize smart hiring of trustworthy sub-investigators and incentivize accuracy in data collection and management. Compensation should not be tied to data quantity, which could compromise accuracy. Implementing a notebook monitoring system tailored to the research protocol can also facilitate easier review for PIs.
By proactively addressing these risks and implementing robust safeguards, researchers can continue to leverage the benefits of DCTs while ensuring the integrity and reliability of clinical trial data.
Future Directions
The Partnership for the Advancement of Clinical Trials (PACT) consortium is expected to publish a detailed study in Q4 2024, comparing 69 active protocols using DCT solutions with benchmarks that did not use such solutions. This study, funded in part by the Reagan-Udall Foundation for the FDA, aims to provide further empirical evidence on the value proposition of DCT deployments.
