While decentralized clinical trials (DCT) capabilities have been quietly evolving for a few years, it was really the onset of the COVID-19 pandemic that forced the biopharmaceutical industry’s hand in expanding the adoption of DCT. As the virus caused clinical research sites to shutter operations, organizations quickly turned to DCT as a necessary pathway to restarting paused trials and launching important new ones. This enforced retooling of the research model shone a spotlight on the potential benefits of a decentralized approach—namely, the potential of DCT to accelerate patient enrollment, improve retention rates, and expand the diversity of both participants and clinicians. The result is a faster, more agile clinical research offering.
According to an Industry Standard Research (ISR) survey, commissioned by Science 37, more than 60% of biopharmaceutical executives reported that, within the past year, their organization had conducted a clinical trial that included at least some DCT components. In addition, more than 80% were planning to conduct a trial with DCT components in the coming year. Yet, six out of 10 acknowledged that their company does not have the internal capabilities to operationalize DCT. With more outsourcing anticipated, the additional elements and vendors will add cost, complexity, and time to an already inefficient and expensive development model.
Incorporating DCT technologies and methodologies into clinical research necessitates proper planning and execution. Here are five key factors to consider.
1. Develop a proactive strategy
Although biopharma companies were able to respond to the pandemic by retrofitting existing clinical trials with decentralized elements—and often with good results—it is unlikely that many of these studies will have reaped the full benefits of DCT, simply because they will not have been following a scalable, measurable strategy for incorporating DCT at the enterprise level.
In contrast, by adopting a proactive DCT approach, sponsors are able to harness multiple investigator and patient networks to reduce startup times from months to mere weeks and deploy centralized teams of remote coordinators and mobile healthcare providers to maximize efficiency and enrich the patient experience. Indeed, ACRO experts cite increased patient engagement as a key advantage of decentralized trials and actions such as gathering patient input during the development process increase patient satisfaction and retention.
2. Consider an agile design
DCT is not an all-or-nothing, one-size-fits-all approach. Developers should first consider which elements can be decentralized and which might be more appropriate for site-based visits. A trial could be conducted, for example, using a telemedicine network to monitor patients remotely, yet may also include traditional site visits for things like imaging, dispensing medication, and outcomes assessment requiring in-person review. Similarly, a trial could potentially combine a traditional, site-based study for local patients who can travel to the site, with a DCT-enabled component that offers participation without geographical restrictions. These decisions will be led in large part by the therapeutic category of the study, of course.
3. Remember, regulators are on your side
The initially slow pace of DCT adoption before the pandemic can be attributed in part to uncertainty around navigating the regulatory environment for non-traditional study designs. Respondents to the Science 37 survey cited “Quality of Data” and “Regulatory/Compliance Risk” as the two most important factors for organizations assessing the viability of DCT. But, based on what we’ve seen in the regulatory landscape over the past year or so, concerns about acceptance and compliance for novel trial designs and methods should dissipate over time.
Global regulators recognized early on the unprecedented disruption of the pandemic to clinical research. In the U.S., the Food and Drug Administration (FDA) issued guidance to the industry for trial continuity, encouraging the use of “alternative methods” for assessments that would assure the safety of trial participants. Similarly, the European Medicines Agency (EMA) issued guidance in early 2020 (updated three times since) that included suggestions such as deploying remote monitoring and home nurses to ensure patient safety and safeguard data quality.
Researchers from the FDA’s Oncology Center for Excellence (OCE) later reflected on the agency’s guidance in a JAMA Oncology article, acknowledging that the increased uptake of digital platforms “adds to the impetus to decentralize clinical trials,” encouraging sponsors to use such tools to support the remote enrollment of more diverse patient populations.
4. True patient-centricity requires work
A key benefit of DCT is its ability to prioritize the needs of the patient. While it is the technology itself that makes this possible, the deployment of tech alone does not equate to patient centricity.
Patient centricity in DCT means having early and continuous dialogue with patients, caregivers, and advocates to learn and understand patients’ individual journeys, their trial experiences, preferences for visits and activities, and any specific challenges they may be encountering.
So, it’s important to remember that while the DCT technology platform underpins each element of the clinical trial—orchestrating workflow, generating evidence, and harmonizing data—the measure of patient centricity in a study is determined, not by the technology or the data, but by the actions and interactions of humans.
5. Support traditional trial sites
As we think about the agile clinical trial, sponsors looking to conduct trials using a combination of physical sites and remote components will need to offer training, support, and ongoing communication to those sites. A November 2020 report from the Tufts Center for the Study of Drug Development found that, prior to the pandemic, more than 60% of investigators were unfamiliar with remote trial processes and solutions—a significant unmet need for individualized training.
While it’s possible to train site staff on the fly in a scenario like a pandemic, it’s not an ideal long-term solution. Adopting a proactive DCT strategy enables sponsors to communicate clearly with sites about how the trial will operate, the technologies involved, what training they can expect, and what support services will be provided throughout the study.
Jonathan Cotliar is the chief medical officer for Science 37. He previously served as vice president of medical affairs, where he contributed as an investigator on a number of virtual clinical trials in addition to his work in support of business development and regulatory strategy.