In our conversations with trial sponsors, ObvioHealth often tackles common misconceptions about decentralized clinical trials (DCTs). These myths hinder our industry’s evolution by keeping sponsors from designing optimal trials that deliver better data with higher retention and compliance rates.
In Part 1 of this blog series, we dispelled misconceptions about the participant experience in DCTs, demonstrating that well-run decentralized trials streamline access to study teams and reduce the participant burden. But, misinformation about DCTs doesn’t stop with the human element—it extends to study design, data quality, and acceptance by regulatory bodies, such as the FDA. In this final post of the series, we’re debunking these myths and uncovering the facts about DCTs.
Not every study will be a fit for a 100% decentralized model, but almost all studies can include some virtual elements. This modular approach to clinical research is called the hybrid method.
Teams can mix-and-match DCT and traditional trial elements throughout the process, from recruitment, enrollment, and onboarding to product distribution and administration, data collection, and assessment. For instance, teams might implement electronic patient-reported outcomes (ePRO) to capture unstructured data while retaining some on-site visits.
As one example, ObvioHealth completed a hybrid clinical trial for the treatment of COVID-19, using an innovative study design with integrated digital devices to remotely monitor patient vitals from home. But, this same study also included (at least) one in-person visit, and included the option of home healthcare visits as well.
Many studies require site visits—whether it’s for bloodwork, imaging or, in the case above, to confirm a patient has COVID-19—but this should not stop sponsors from including virtual elements where possible. Including these elements lessens the burden on patients, and as a result can increase compliance and retention rates.
DCT tools allow teams to capture unstructured data, such as images and audio, which can produce richer, more nuanced findings. For instance, ObvioHealth is currently conducting a colic study, which involves capturing the audio of infant cries, as well as a study on stool, which incorporates images.
Devices such as smartphones and wearables generate continuous data, which can tell a fuller story than point-in-time data. They also provide the ability to capture outcomes in a real-world setting rather than a clinical setting.
DCTs can also improve data quality by streamlining and augmenting the expert clinical rating process, which reduces the human subjectivity inherent in patient-reported outcomes and minimizes variability among clinical experts.
Recent draft guidance from the Food and Drug Administration sheds light on the agency’s approach to the digital health technologies used to capture data in DCTs.
“Advances in sensor technology, general-purpose computing platforms, and methods for data transmission and storage have revolutionized the ability to remotely obtain and analyze clinically relevant information from individuals,” the guidance notes. “DHTs (digital health technologies) used for remote data acquisition are playing a growing role in health care and offer important opportunities in clinical research.”
This guidance, along with numerous other publications by the regulatory agency, shows that the FDA is receptive to DCTs and acknowledges the advantages of these studies.
“Decentralized Clinical Trials (DCTs) may have several potential benefits including reduced patient and sponsor burden and increased accrual and retention of a more diverse trial population,” according to The FDA Oncology Center of Excellence.
ObvioHealth has successfully steered numerous DCTs and helped prepare submissions for regulators throughout our work in 28 countries. We’re experienced at working with sponsors to generate high-quality outcomes that pass the scrutiny of regulatory agencies.
Now that we’ve covered the six most troublesome myths about DCTs, it’s time to toss them once and for all, and embrace the evidence that decentralized and hybrid trials are here to stay. As more sponsors recognize the potential of DCTs, these outdated perceptions will continue to fade away. ObvioHealth helps sponsors adopt DCT elements that are suited to their study needs and goals—driving data quality, generating meaningful outcomes, and moving the industry forward.
Missed Part 1 of the series? Read it now by clicking here.