Pamela Tenaerts, MD, is Medable's Chief Scientific Officer, and aims to drive advancement of decentralized research methodologies with evidence-based best practices. She brings more than two decades of clinical research experience having previously served as Executive Director of the Clinical Trials Transformation Initiative (CTTI), Director of Clinical Programs at Coaxia, Director of the Clinical Research Center at Sarasota Memorial Hospital, and various other research positions.
he FDA has made a purposeful choice to write in broad strokes, stopping short of detailing ways to execute DCTs. Even so, the Agency is starting to acknowledge – and thereby support – the global shift towards expanded trial models. Essentially, the FDA is implicitly broadening the definition of clinical trials.