As the COVID-19 pandemic rages on, clinical trial conduct is being reimagined in ways few thought possible. As all stakeholders rethink how to develop protocols, consent patients, ensure compliance, and gather quality clinical trial data when patients and staff are remote, patient centricity has stepped to the forefront. A clinical trial is a research study involving human volunteers (also called participants) that is intended to add to medical knowledge.
To quantify this trend, the Society for Clinical Research Sites (SCRS) collaborated with Medidata (a Dassault Systems Company) to survey and measure current and anticipated levels of adoption of patient-centric tools, and the sites’ perspective on how patients have reacted to them.
Examples of alternative technologies include electronic clinical outcomes assessments (eCOA), wearables, and televisits.
The output appears in a white paper titled “Patient Centricity and Virtualizing Technologies in a COVID-19 World: Measuring how the pandemic is driving adoption of digital tools in fully virtual, hybrid, and traditional clinical trials.”
Counter to expectation, the survey revealed that sites are receptive to virtualizing technologies that facilitate their work while enhancing the patient experience. Such information can enable healthcare to inform their internal technology strategy.
Regulatory agencies have generally been supportive of these endeavours, with the U.S. Food and Drug Administration (FDA) stating that sponsors of clinical trials who are planning to use remote electronic assessments as part of a clinical investigation can do so.
However, the agency recommends that companies adopt the use of appropriate technology and develop procedures for provision of technology and technical support to trial participants, investigators, and other trial personnel to facilitate those assessments.
Similar guidance appears from the Europe union, via the European Medicines Agency (EMA).The supranational body cautions that clinical trial sponsor consider in their risk
Assessment, especially in relation to the conversion of physical visits into phone or video visits. Further caution is required in relation to any postponement or complete cancellation of visits.
As part of minimizing contact due to coronavirus infection risk, the EMA understands that measures need to be taken in order to ensure that only strictly necessary visits are performed at sites.
Health Canada is also open to the use of alternative technologies to keep the clinical trial process in check. The agency advises that investigators evaluate whether alternative methods for safety assessment are feasible should participants not be able to come to the investigational sites as specified in the study protocol. Hence, alternative methods may need to be developed.
Examples of other alternative methods include phone contact, virtual visits via telemedicine or alternative care sites.