Sharpening the Focus on Patient-Centricity as Pandemic Continues

The foundation is rooted in strategic partnerships with contract research organizations (CROs), vendors, and associations who share collective wisdom to develop best practices or apply knowledge acquired from clinical care to the clinical trial realm. A recent analysis suggests that the global market for DCTs is expected to reach $10 billion by 2026, rising at a 6.5% compound annual growth rate between 2020-2026.2 As evidence of this growth, the SCRS/Medidata survey found that televisits, already used in the past two years by 45.1% of the 204 respondents, are likely to be adopted by an additional 39.2% of respondents in the next two years.1 The survey also reported that only 15.5% of respondents participated in decentralized or completely virtual trials in the past two years. Melissa Nezos, Vice President of Clinical Operations at Firma Clinical Research, a provider of in-home health services, comments on the ongoing shift toward DCTs. Regarding the use of more home-based visits, Rasmus Hogreffe, Vice President of Decentralized Clinical Trial Innovation at Medable, a provider of a DCT platform, says, "We are seeing rising decentralized trial adoption in the industry on a daily basis, including home visits.

Revamping Site Feasibility as Trials Become Decentralized

[...]this critical step is receiving the attention it deserves, maybe even an overhaul, as the wave of clinical trial decentralization surges on. With this regulatory foundation, the site feasibility process involves choosing sites that not only conform to these requirements, but can also offer the best fit for specific studies, based on past performance, access to a database of appropriate patients, and the bandwidth to perform the study at hand. A recent article by Kurbegov et al. of the American Society of Cancer Oncology (ASCO) describes a Task Force that was convened to evaluate the burdens and challenges of site feasibility, which often lead to delayed study start-up and act as a barrier to site participation.6 With input from sites, sponsors, and CROs in the form of surveys and in-person meetings, the Task Force developed three recommendations for improvement, with a goal of speeding patient access to clinical trial participation, and ultimately, much needed new treatments, as shown in Table 1 on the facing page. According to Comis, "We now have 146,000 users of SIP, which represents 125,000 site researchers.

COVID-Sparked Practices Driving New Patient-Centric Behaviors

To explore these major shifts, several clinical trial stakeholders were interviewed to gain an understanding of remote processes unfolding in the era of COVID-19, and how smart technologies and mobile health staff are key to sites making this transformation. Upheaval now Starting in March, stories began appearing about sponsors slashing clinical trial activity as the coronavirus was actively spreading across the globe.2,3 This slow-down reflects an all-out effort to protect the trial participants and site staff, meaning that study visits are being reduced, shifted to tele-visits, or cut entirely. [...]the traditional study model, whereby all visits take place at the site, is giving way to a more virtual approach, with technologies and platforms enabling this transition. Cioffi adds that sites also have issues with remote monitoring, as source documents cannot leave the site, and any efforts to monitor them remotely must be in accordance with HIPAA guidelines.