All Times EDT
Keywords: Clinical Trials
Since the 21st Century Cures Act passed, real-world data (RWD) and real-world evidence have garnered significant interest. While some sources of RWD, such as electronic health records, have generated significant and extensive discussions about their strengths and weaknesses, virtual clinical trials (VCTs) have not been discussed as extensively. VCTs have their own distinct advantages and disadvantages which stem from their unique trial conduct features. With online participation, VCTs present the opportunity to potentially expand clinical trial participation, but may restrict the generalizability of trials in new, unanticipated ways and may be more or differently susceptible to loss-to-follow-up and missing than traditional clinical trials. Similarly, while VCTs allow for prospective data collection, an inherent strength, VCT data provided by patients introducing new challenges to trial conduct in order to ensure that data collection is timely, consistent, and complete. Furthermore, patients may easily be overwhelmed by the amount of data collected, leading to missingness or inaccurate data. These issues impact not only the study design and conduct, but also the analyses and presentation of results from VCTs.