Decentralized clinical trials (DCTs) are transforming clinical research by allowing data collection from participants outside traditional settings, such as in their homes. While this shift offers significant benefits, it also presents new challenges for institutional review boards (IRBs), which must review the digital technologies used in these trials to ensure participant safety and data accuracy.
Decentralized Trials: The Shift From Paper to Digital
Historically, clinical trials relied on paper-based methods for collecting clinical outcomes assessments (COA), such as diaries or journals participants filled out and returned. This method was prone to various errors, including recall bias, where participants would hurriedly fill in missing information just before a clinic visit, often resulting in inaccurate data.
Today, DCTs leverage electronic tools like electronic clinical outcome assessments (eCOA) and electronic patient-reported outcomes (ePRO), allowing participants to submit data in real-time through their smartphones, tablets, or computers. This shift to digital platforms has significantly improved data accuracy and reduced errors associated with manual transcription.
The co-founder of a clinical research organization emphasized the move to digital tools, especially using participants’ own devices, known as the bring your own device (BYOD) model, enhances both participant compliance and engagement. With BYOD, participants can provide data at their convenience, increasing the likelihood of timely and accurate data collection. The flexibility to use personal devices has proven especially valuable in the context of COVID-19, which accelerated the adoption of remote data capture technologies across the industry.
The Role of IRBs in Reviewing Digital Trial Technologies
One of the challenges for IRBs in this new digital environment is adapting their review processes to accommodate DCT technologies. In the past, IRBs would request final versions or screenshots of digital tools, such as electronic diaries or consent forms, to ensure participants were presented with approved content. While well-intentioned, this process often caused delays in study startups, particularly in trials involving multiple languages or device formats.
Producing screenshots for IRB review can take weeks, or even months, particularly when translations and multiple device versions are involved. By the time these screenshots are ready, trial timelines may already have been significantly delayed.
Recognizing this issue, Advarra and other IRBs are updating their approach. Rather than reviewing screenshots of finalized digital content, Advarra now focuses on reviewing the process by which the approved content is transferred to digital platforms. This approach ensures the IRB-approved content is presented to participants correctly, without the need for repeated visual confirmations. By focusing on the integrity of the process rather than the final product, this change is expected to reduce delays and streamline trial initiation.
Ensuring Safety and Data Quality in Decentralized Trials
Although the new approach improves efficiency, IRBs must continue to ensure DCT technologies uphold participant safety and data quality. One potential concern arises when protocols are modified mid-trial. In the past, if an electronic diary or consent form needed to be updated, IRBs would often require final screenshots before approving the changes. This step could delay the delivery of critical updates to participants.
To address this issue, Advarra has eliminated the need for post-approval screenshots for electronic consent (eConsent) and now prioritizes faster updates to ensure participants receive the latest risk information as quickly as possible. This change underscores the importance of balancing regulatory requirements with the need for timely participant communication.
The quality of data collected in decentralized trials is another area of focus. Digital tools, such as eCOA and ePRO, allow participants to submit data in real-time, providing more accurate and timely information than paper-based methods. The co-founder of the clinical research organization emphasized digital data capture not only reduces errors but also increases participant engagement, as it allows individuals to report data from the comfort of their homes at times suitable to them.
The Future of IRB Approvals for Decentralized Trials
Looking ahead, IRBs must continue evolving to keep pace with advancements in clinical trial technologies. One promising area is the use of voice-assisted technologies, which could make clinical trials more accessible to participants with vision impairments or literacy challenges. Voice assistants, for example, could allow participants to provide data verbally rather than through traditional text-based methods. While this technology offers exciting potential, it will also require IRBs to develop new review processes for these novel data collection methods.
The evolution of IRB review processes is critical to advancing decentralized clinical trials while maintaining participant safety and data integrity. By streamlining the review process and embracing new technologies, IRBs can help accelerate clinical trials, reduce delays, and ensure life-saving treatments reach the market faster. As DCTs become more prevalent, the collaborative efforts of sponsors, IRBs, and clinical research organizations will be essential in shaping the future of clinical research.
