By Pamela Tenaerts, Chief Scientific Officer; Kevin Potgieter, VP Regulatory; Mohammed Ali, Chief Domain Officer
The issuance of the FDA's Decentralized Clinical Trial (DCT) Draft Guidance in May 2023 has triggered a surge of enthusiasm and expectancy in the realm of clinical trials. This highly anticipated directive marks a notable achievement in the advancement of clinical trial approaches, underscoring the FDA's endorsement of the widespread adoption of more comprehensive trial frameworks. The guidance further solidifies the FDA's dedication to fostering innovation in the design of clinical trials, while also stressing the importance of meticulous deliberation, training, supervision, and risk mitigation to ensure the effective execution of DCTs.
Get an overview of different perspectives about the draft guidance and key points that can be used to reinforce decentralized clinical trial training, oversight, and risk assessment to ensure a study's integrity, patient safety, and success.