Cami Gearhart Image

by Cami Gearhart

Letter From the CEO

Institution Bulletin vol 5, issue 3

At Quorum Review, we are committed to helping the research community safely bring innovative medications to those who need them. Today’s issue of the Institution Bulletin provides a number of tools to help you and your human research protection program navigate the world of research ethics.

The pharmaceutical industry continues to turn to academic medical centers and other institutions for inspiration and innovation, and much of our most innovative research is generated by solo researchers. The FDA has just published draft guidance to assist these researchers (and their institutions) understand when and how to conduct this research under the “investigational new drug” (IND) regulations. Our first article summarizes the draft guidance and explains how the IND requirements intersect with IRB submission requirements.

Our second article addresses the challenge of how to contract with central IRBs as the NIH and industry sponsors increase their insistence on a single IRB of record for multi-site studies. We’ve included a discussion of the tools developed by the Clinical Trials Transformation Initiative (CTTI) to assist with these efforts.

Finally, the results of an interesting meta-analysis of Phase I studies was published earlier this summer. This meta-analysis attempted to assess the seriousness of adverse events suffered in 394 Phase I trials conducted by Pfizer Pharmaceuticals over the course of seven years. The results are somewhat surprising. The enclosed article reviews those findings and suggests issues that IRBs consider when reviewing Phase I studies.

If and when it makes sense for your institution to outsource IRB review, we are committed to supporting you with a high quality review and a strong regulatory team. I hope you find these articles useful, and we look forward to an opportunity to work with you further.

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