February 19, 2020

Introduction
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Virtual approaches to clinical research leverage digital technologies to relieve study sites of many, if not all, responsibilities of the research process—from identifying potential study subjects to screening them for eligibility to obtaining their consent for enrollment to entering their study data.

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Such approaches have the potential to unleash the power of the patient by bringing the research process to patients versus requiring patients to bring themselves to the research process. Doing so makes sense, as statistics suggest that less than five percent of the population ever participate in clinical research (even though the vast majority report being willing to do so), and study location ranks second only to receiving placebo among the most disliked aspects of clinical trial participation. There are also cost savings at stake, as reductions in site involvement and investigator burden associated with virtual approaches fuel expectations for corresponding reductions in the costs of clinical research. It is no wonder, then, that biopharmaceutical companies are actively seeking opportunities for "going virtual" in their clinical development programs.

But their enthusiasm is tempered by a lack of understanding of virtual approaches, inadequate experience with digital tools for data capture and, most importantly, the risk of things going wrong in their all-important Phase II-III clinical trials. A recent

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survey asked manufacturers to list the biggest challenges they are facing in adopting virtual clinical trials. While 17 percent said they simply "did not know how to start," 23 percent cited "perceived regulatory risk" and 38 percent pointed to "risk associated with novel technology" as the problem. These concerns, along with the naturally simpatico relationship between digital technologies and real-world measures, have led to a disproportionate growth in the use of virtual approaches in the real-world setting as opposed to randomized controlled trials. So, in response to the question about what virtual research is doing in the real-world setting, the short answer is "a lot." The real-world realm has often served as testing grounds for clinical trial innovation—and things are no different with virtual research. Nonetheless, it is still the case that confusion abounds as to what virtual research is, what it should be called, and whether there are distinct types of it in the real world. The objective of this paper is to bring clarity to these issues.

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