Adoption of Decentralized Trial Elements in Cancer Clinical Trials Supporting FDA Approvals during COVID-19.

ABSTRACT: The COVID-19 pandemic disrupted cancer clinical trials, prompting sponsors to adopt decentralized clinical trial (DCT) elements to ensure patient safety and trial continuity. Supported by FDA emergency guidance, the FDA Oncology Center of Excellence, in collaboration with the Clinical Trials Transformation Initiative, conducted an assessment of DCT elements in cancer trials leading to FDA approval during the pandemic. Between December 6, 2022, and January 17, 2023, the Clinical Trials Transformation Initiative collected survey data from trial sponsors about DCT elements used in response to the pandemic, implementation challenges, and anticipated future use. Of 52 eligible trials, 19 responses were received from 13 sponsors, predominantly large pharmaceutical companies. The majority of tria

SUBMITTER: Patel TH 

PROVIDER: S-EPMC12081193 | biostudies-literature | 2025 May

REPOSITORIES: biostudies-literature