The majority of clinical trials are conducted at major research institutions or clinics, often based in urban areas. This can create problems of accessibility for many potential patients who live more than two hours from a trial site or who have work and family responsibilities that make it difficult for them to participate. It also creates significant issues in terms of patient diversity. In early June, the U.S. Food and Drug Administration (FDA) issued a draft guidance on improving the diversity of patient populations in clinical trials. The biggest focus is on getting sponsor companies to include more historically underserved populations in clinical trials, including women, the elderly and minorities. The 18-page guidance makes numerous recommendations, including enrichment, inclusive trial practices and design, and methodological ways to bring in a wider range of patient populations. One of the first recommendations under “Make Trial Participation Less Burdensome for Participants,” is to take into consideration recruitment challenges that might be caused by a planned visit schedule. The guidance states: “Reduce the frequency of study visits to those needed to appropriately monitor safety and efficacy and consider whether flexibility in visit windows is possible and whether electronic communication (e.g., telephone/mobile telephone, secured electronic mail, social media platforms) or mobile technology tools can be used to replace site visits and provide investigators with real-time data.” Jonathan Cotliar , chief medical officer of Science 37 , a technology-enabled virtual trial research company, took time to talk with BioSpace about virtual clinical trials and the role telemedicine, a platform designed specifically to operationalize virtual trials, and biowearables, can play in clinical trials. “Science 37 was founded almost five years ago by two physician-scientists who understood that clinical trials had a variety of problems—primarily drugs were taking too long to get to the market, were too […]
What Are Virtual Clinical Trials? An Interview with Science 37’s Jonathan Cotliar
