1408P - The United Kingdom (UK) National Cancer Research Network (NCRN) Chemotherapy and Pharmacy Advisory Service (CPAS): service development and quality...

Date 28 September 2014
Event ESMO 2014
Session Poster Display session
Topics Anti-Cancer Agents & Biologic Therapy
Bioethics, Legal, and Economic Issues
Presenter Philip Debruyne
Citation Annals of Oncology (2014) 25 (suppl_4): iv486-iv493. 10.1093/annonc/mdu353
Authors P.R. Debruyne1, P. Johnson2, L. Pottel1, S. Daniels3, R. Greer4, E. Hodgkinson5, S. Kelly6, M. Lycke1, J. Samol7, J. Simpson8, D. Kimber9, E. Loucaides10, M.K. Parmar11, S. Harvey12
  • 1Campus Loofstraat - Cancer Center, General Hospital Groeninge, 8500 - Kortrijk/BE
  • 2Department Of Molecular And Clinical Cancer Medicine, University of Liverpool, Liverpool/GB
  • 3Pharmacy Cancer Services, University College London Hospitals, London/GB
  • 4Clinical Pharmacology, 5Leeds Teaching Hospital NHS Trust, Leeds/GB
  • 5Clinical Pharmacology, 6Sheffield Teaching Hospitals NHS Foundation Trust, Scheffield/GB
  • 6Dept. Oncology Uk, Pfizer Ltd., GB-KT20 7NS - Tadworth/GB
  • 7Medical Oncology, St George's Hospital, GB-SW17 0QT - London/GB
  • 8Clinical Pharmacology, Sandwell and West Birmingham Hospitals NHS Trust, West Midlands/GB
  • 9Wessex Clinical Senate & Strategic Networks, NHS England, Southampton/GB
  • 10Ncri Clinical Studies Groups, NCRI Clinical Studies Groups, London/GB
  • 11Medical Research Council (mrc)mrc Clinical Trials Unit, University College London, GB-NW1 2DA - London/GB
  • 12Ncrn Cpas, National Cancer Research Network Coordinating Centre, London/GB

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.