Use of a Novel Risk Rating System in Early Clinical Trials

Dr Brian Leaker, Respiratory Clinical Trials.

Proceedings from AHPPI’s conference on Risk Management in Early Phase Clinical Trials, 29 Oct 2015 (link).



Brian outlined the structure of his unit and, in particular, the research side of the operation. The unit has a “Medical Advisory Committee” one of whose functions is to minimise risk. Reporting to the MAC is the Research Governance Committee which has an independent Chair who is a clinical pharmacologist and independent members in the form of a toxicologist and QP and non-voting members from the unit itself. The committee’s remit is to review protocols and related IBs and other relevant information and to quantify risk. It does this on an ongoing basis and requires a majority verdict.

05. Brian Leaker_RCT

The committee uses a scoring system which forms a matrix with risk score (graded 1-4) down the side and factors including IMP, methods to be used and intended population across the top.  This means that by positioning risk categories using the main protocol events such as IMP nature and formulation, potentially invasive methods etc a Risk score can be read off the matrix.

Brian went on to give several specific examples of studies which they had performed in the Respiratory field and how they had scored them along with the results of each study which supported the categorization method which they had used.

This was an interesting and very practically based talk describing a model which might well be adapted for general Phase I (and maybe later phase) studies.

Written by Dr Peter Dewland, Peter Dewland Consulting. Peter is an independent peterconsultant in pharmaceutical medicine and has a Master’s degree in Medical Ethics together with degrees in Biochemistry and Medicine along with 30 years experience of developing new drugs. He is a founder member of the Faculty of Pharmaceutical Medicine and now both teaches and examines students of this specialty. He is a past Chairman and current Treasurer of the AHPPI.

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