Virtual Clinical Trials: A New Model for Patient Engagement
For some patients, the ability to participate in a clinical trial from the comfort of one’s home is becoming a reality.
Nearly 70 percent of potential clinical trial participants live more than two hours away from a study center, limiting their opportunities to benefit from possibly life-changing therapies. For many, getting to the site for one or multiple visits is not an option. However, digital health technologies – including mobile phone apps, fitness trackers and other wearables, and electronic patient portals – are enabling some clinical trials to be conducted partially or entirely remotely.
At a recent National Academies workshop, panelists examined the potential benefits of virtual clinical trials, such as faster participant recruitment and improved retention; fewer geographic, financial, and time barriers for participants; and increased participant diversity and representation.
For example, Parkinson’s disease is one area where virtual clinical trials have reduced barriers to participation, particularly for patients with cognitive and physical impairment. Recent virtual clinical trials have allowed patients to give consent electronically, participate in virtual doctor visits, receive study drug shipments at home, and use their smartphones to self-report their symptoms and health changes that arise during treatment. This year, for the first time, the National Institute on Aging will be recruiting 3,500 people with Parkinson’s disease for a clinical trial that will be conducted entirely in the patients’ homes.
In-person clinical trials are not going away, panelists emphasized. Many studies need to perform MRIs, biopsies, and other assessments that cannot take place at a patient’s home. Virtual clinical trials also come with challenges related to accurate and secure data collection.
“Virtual trials may require greater inclusion of patients in the design and governance than traditional clinical trials,” said workshop co-chair Clay Johnston, dean of the Dell Medical School at the University of Texas at Austin. Johnston described several ways that investigators can earn the trust of virtual trial participants by engaging them in early study design, being clear about how their data will be used, and focusing on their overall experience and quality of life, not just on the treatment being studied.
The full proceedings of the workshop are available here.