A | VIRTUAL CLINICAL TRIALS (VCTs) PRESENT MANY OPPORTUNITIES, including increased monitoring and compliance, and enhanced opportunities for patients to participate, particularly those in rural areas. However, some of the challenges to consider with VCTs include ensuring a consistent environment and trial conditions for each patient, training on sample/data collection, and shipping/ transmitting the information. A move to VCTs, especially for pivotal/label-enabling trials, also requires input and agreement from the FDA. Companies might consider starting with exploratory studies to identify issues and solutions before implementing in earlier-stage trials where safety is unknown, or later-stage trials that require rigorous controls. Before implementing, you should be asking yourself how VCTs can improve the quality of data and efficiency of clinical trials (while addressing patient needs), instead of just saying “We have this technology; let’s try it.”
THOMAS WIGGANS is chairman and CEO of Dermira. He has served as CEO of other biotechs and boards and currently serves on the BIO board of directors.