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 trials (89%) included both U.S. and international sites, and nearly all sponsors (95%) adopted at least one DCT element during the pandemic. Key DCT elements included remote site monitoring (89%), telemedicine (68%), remote laboratory assessments (63%), and remote distribution of investigational products (58%). Main challenges encountered included institutional policies (83%), technology adoption (61%), and regulatory restrictions (56%). Despite challenges, sponsors showed strong intent to continue DCT use, especially for remote monitoring, patient-reported outcomes collection, and telemedicine. This study demonstrates the viability of DCT elements for generating FDA-approvable data, suggesting potential for expanded trial access and reduced patient burden. Continued attention to site-level challenges is needed to sustain DCT adoption in cancer clinical trials.