A | THERE IS GROWING INTEREST IN USING “REAL-WORLD DATA AND EVIDENCE” (RWD/E) in the drug-approval process, blurring the lines between clinical care and controlled/randomized clinical trials. The FDA has issued initial guidance in this arena, and many organizations are considering the potential for pragmatic randomized clinical trials. Claims or EHRs are now incorporated as part of the comparator against the experimental medicine or new medical procedures. Over time, there is likely to be increased utilization of observational studies that will be used in development and approval processes (e.g., prospective data collection through registry studies). The issues as this process evolves are to ensure that relevant questions are asked and that appropriate data is collected and analyzed. New digital technologies will certainly increase the abundance of data that contributes to this process.
KENNETH MOCH, president and CEO of Cognition Therapeutics, has 30 years of experience building and financing biomedical companies. Moch has been CEO of five life sciences companies, including Chimerix, Alteon, and Biocyte, as well as cofounding The LiposomeCompany (acquired by Elan).