New DF/HCC Phase I Review Initiative (PRI)

To: DF/HCC clinical and translational investigators   From: George Demetri and Dave Ryan, Associate Directors for Clinical Sciences, DF/HCC   Designing and implementing the most innovative clinical research to test hypotheses is a key component of our Cancer Center, and we know that speed and quality are both key components to this process for all clinical research trials.  We are making a commitment to DF/HCC investigators to revise our processes so that we support both components in the best possible ways.   As a first step, we are pleased to announce the immediate implementation of a new process for the review of our phase I clinical studies. This Phase I Review Initiative (PRI), which has been designed in association with Jeff Clark, Michele Russell-Einhorn, Amanda Hammond and other colleagues at the Office for Human Research Studies, compresses protocol review timelines with the goal of achieving IRB approval within 60 days of protocol submission.   All phase I trial applications will be assigned to PRI upon submission, and the investigators will be assigned target dates both for review and for study team responses. It is important that for PRI-designated protocols, investigators and study sponsors (most importantly, external industrial collaborators) must commit to provide very rapid response to any biostatistical and other departmental review comments prior to the SRC meeting, as well as to timely resolution of any issues raised during SRC and...
Source: DF/HCC: Latest News - Category: Cancer & Oncology Source Type: news