Abstract
ABSTRACT Aim: The Chemotherapy and Pharmacy Advisory Service (CPAS) was established in 2007 by the UK National Cancer Research Network (NCRN) to improve the quality of pharmacy-related issues in clinical research protocols. We report the scope and methodology of the CPAS, and its impact on the quality of clinical research protocols. Methods: All clinical research protocols were independently reviewed by a minimum of three health professionals including at least one oncology pharmacist, using a customised protocol review checklist (assessing 12 areas of clinical oncology/pharmacy). A collated review was subsequently drafted by the CPAS pharmacy advisor and returned to the chief investigators. A working party performed a systematic review of all protocol reviews conducted by CPAS during the 6-year period since its inception (2008-2013) and categorised the remarks. A service evaluation audit was conducted to check response rate and acceptance rate of the proposed changes with chief investigators. Results: During the 6 year systematic review period a total of 176 clinical research protocols were reviewed. The median number of remarks per protocol was 26 of which 20 were deemed clinically relevant. The majority of clinically relevant remarks concerned the drug regimen, guidelines concerning support medication, frequency and type of monitoring and drug supply aspects. Further analysis of the 176 protocols reviewed revealed that 62% of chief investigators responded to the review. All responses were positive with an overall acceptance rate of 89% of the proposed protocol changes. Conclusions: Review of pharmacy aspects regarding clinical cancer research protocols is feasible and reveals many undetected clinically relevant issues that could hinder efficient trial conduct. Our service audit revealed that the very large majority of suggestions were effectively incorporated in the final protocols. Disclosure: All authors have declared no conflicts of interest.
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