IN 2020, THE FDA ISSUED GUIDANCE THAT GAVE COMPANIES THE OPPORTUNITY to make their trials more patient-centric. This included employing remote data monitoring, eConsent, telehealth, homehealth, direct-to-patient drug delivery, decentralized lab/blood work, siteless clinical trials, and other alternative strategies. It will be important for companies and patient advocacy groups to work together to request FDA published guidance on how the agency will accept data generated from remote sources. When this occurs, and we simplify our protocol requirements to reduce on-site visits, and we bring the clinical trial to the patient, enrollment and retention in our trials will improve.
MITCHELL KATZ, PH.D., has 30 years’ experience in the pharma and biotech industries, including preclinical research, pharma operations, and regulatory affairs. He is VP of development operations at Ferring Pharmaceuticals.