by Darcy Grabenstein
The COVID-19 pandemic precipitated a move from traditional, site-based clinical trials to a decentralized approach, one that could become the norm rather than the exception.
DCTs were discussed at the annual summit of the Organization of Pharmaceutical Producers of India (OPPI). Pink Sheet covered the summit, reporting that Christoph Koenen, global head of clinical development and operations at Bayer AG, noted “it might not be a black or white scenario where you will have a study that is done 100% brick and mortar and 100% DCT.”
As Scrip reports, whether patients need to be physically present at a trial site is likely to depend on a number of variables, such as the safety profile of the drug or intervention under investigation, the needs of the patient population, and protocol elements that require specific in-person contact. In some cases, sites may be more agreeable to participate in a hybrid study in which the first visit is conducted in the clinic, so that the physician can walk through the details of the trial and address any patient concerns. This would also allow for the site staff to observe the patient’s first dose, further prioritizing safety.
A hybrid format such as this provides the greatest flexibility for participants. Technology, such as wearables to monitor patients, can capture data — continuous vs. episodic — that would not be available during site visits alone. Another potential benefit of DCTs is an increase in patient diversity, as nearly 75% of patients preferred the at-home model for participating in trials, according to the Petrie-Flom Center of Harvard Law. DCTs have also contributed to diversity as they appeal to women and Blacks, the Tufts Center for the Study of Drug Development reports.
However, with DCTs sponsors must put an increased emphasis patient centricity by building and maintaining relationships, in this case between the trial team and patients. In addition, this approach can present logistical and regulatory challenges for trial sites, with patient safety and privacy key considerations.
If investment in virtual trial companies is any indication of DCTs’ staying power, they will be here for the long haul. Since Jan. 1, 2020, approximately $1.9 billion has been invested in virtual trial companies. Approximately 75% of that investment was in the last half of 2021.
According to Florence Healthcare’s 2021 State of Clinical Trial Technology Industry Report, 83% of sites and 80% of sponsors invested in decentralized study capabilities such as remote monitoring. And an EY-Parthenon survey of 69 sponsor pharma/biotech companies and CRO decision makers revealed that the current clinical trial landscape is split as follows: 60% conventional trials, 24% hybrid trials, and 16% decentralized trials. But by 2024, survey respondents indicated that 28% and 22% of trials will be hybrid and decentralized, respectively.
As innovation in medical device technologies continues, it will encompass a growing number of stakeholders within the healthcare ecosystem, some of which may be new to regulatory requirements. In response, the Food and Drug Administration (FDA) has developed and updated guidances as medical devices become more connected. The FDA is also encouraging the development of Prescription Digital Therapeutic (PDT) devices — freestanding apps that help patients manage chronic diseases and behavioral disorders.
In addition, the Critical Path Institute’s Electronic Patient-Reported Outcome (ePRO) Consortium has published recommendations for the use of wearable device data in making regulatory clinical trial decisions.
Experts at contract research organization (CRO) ICON plc note that while the clinical trials industry has lagged behind other industries in the digital technology revolution, incorporating digital health is necessary to thrive in an increasingly competitive market. Trial sites that are currently reluctant to move into the decentralized model may have to embrace change, even if they believe it could impact their revenue from site visits. We will, however, witness the industry pushing boundaries on digital, data and analytics strategies as sponsors continue to deploy remote assessment of vitals and use digital endpoints, increasing virtualization of clinical trials.
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