FDA Puts Its Weight Behind Virtual Clinical Trials
(Thursday, June 8, 2023)
Decentralized or Virtual clinical trials have emerged as a game-changing approach to study the efficacy and safety of new treatments and interventions. But the regulatory expectations from these trial designs were not clarified. That is, till now. With two guidance documents released within the last month, the FDA has expressed its strong support for trial designs that rely heavily on remote monitoring, virtual visits, digital health technologies, and electronic records.
Decentralized clinical trials (DCT) are defined as trials where some or all of the trial-related activities such as patient interactions and biospecimen collection and testing, occur at locations other than traditional clinical trial sites. Most clinical trials involve at least some activities that are conducted at locations other than the site such as imaging and testing of clinical samples. However, a DCT also includes remote patient interactions, wearable devices to collect patient data off-site, electronic source documents and case report forms that can be reviewed remotely, and fewer visits by the patients to the site. Typically, a trial that involves at least a few on-site activities performed at a traditional site is more accurately referred to as a “hybrid” trial.
A fully decentralized trial or a virtual clinical trial is one that is completely technology-based. There are no physical sites and no face-to-face interactions between the patient, investigators, and sponsor’s monitors. Patients enroll in the study remotely by signing remote informed consent, data is collected via phones, apps, watches, e-diaries and other tools, all testing, imaging, and outcomes are measured remotely, and clinical trial activities are managed centrally. There is no patient and caregiver interaction – only data movement. There are obvious challenges with such trial designs. While fully DCT can in principle ease patient recruitment, patients could feel uncomfortable with the lack of caregiver contact leading to high drop-out. There are also challenges with assuring data authenticity and integrity. That is perhaps why FDA does not like to use the term Virtual Trial but uses DCT instead.
FDA’s two guidance documents try to clarify the regulatory requirements and expectations from DCTs. The first guidance released last month built on more than a decade of experience highlighted the nuances of such trials. Yesterday, FDA released its adaptation of ICH E6 Revision 3, that was adapted by the ICH in March of this year. In this revision of the GCP guidance, FDA further emphasized its support for DCTs by incorporating the word “remote” strategically in all critical areas of clinical operations: informed consent, data collection, electronic records, and monitoring. The intent is to modernize clinical trials to improve efficiency and access to patients with digital technology while ensuring human subject protection and reliability of trial results.
Virtual clinical trials leverage cutting-edge digital health technologies, such as wearables and sensors, to collect a vast array of relevant data in real-time while minimizing the burden on participants. This expanded data collection capability allows for the inclusion of diverse patient populations, fostering greater inclusivity in clinical trials. Moreover, the use of wearable sensors and other digital health technologies facilitates agile data collection, enhancing the speed and accuracy of trial outcomes. The emphasis should be on “risk-based and proportionate approaches across the lifecycle of a clinical trial (e.g., data collection, monitoring, quality management)”.
Dr. Mukesh Kumar
Founder & CEO, FDAMap
Linkedin: Mukesh Kumar, PhD, RAC