On November 28, Crowell Health Solutions published a white paper outlining several policy recommendations to advance widespread adoption of decentralized clinical trials (DCTs). The white paper titled, “Advancing Adoption of Decentralized Clinical Trials: Rationale, Current State, and Policy Recommendations” examines the current environment on decentralized and hybrid clinical trials, including a discussion on benefits and challenges that DCTs may pose; existing legislation and regulation; and background on programs and policies that can be leveraged to support DCT adoption.Continue Reading Crowell Health Solutions Examines the Adoption of Decentralized Clinical Trials and Provides Policy Recommendations
Decentralized Trials
FDA Decentralized Clinical Trials Draft Guidance
By Jodi G. Daniel & Cara Tenenbaum on
Posted in Decentralized Trials, FDA
On May 2, FDA published a draft guidance on decentralized clinical trials (DCTs) to provide recommendations for sponsors, investigators and others on implementation of DCTs, as required by the Food and Drug Omnibus Reform Act (FDORA).
Background
DCTs include both fully decentralized trials – where all trial activities take place at locations other than trial…