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Announcement of 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 IRB reviews. OHRS will track compliance with these timelines and remove protocols from PRI that do not meet the requirements for timely investigator/study team responses.
 
We are enthusiastic that this new review initiative will be the first step to improving our DF/HCC process for protocol review, approval and activation of all clinical research studies, starting with this subset of Phase I trials.  We look forward to hearing your thoughts as well as tracking your experiences with this new process.
 
Best regards.
 
George and Dave
 
____________________________________________
George Demetri MD and David Ryan MD
 
Co-Associate Directors for Clinical Sciences
Dana-Farber/Harvard Cancer Center

gdemetri@partners.org <mailto:gdemetri@partners.org>
dpryan@partners.org <mailto:dpryan@partners.org>