title: Optimisation of pharmacy content in clinical cancer research protocols: Experience of the United Kingdom Chemotherapy and Pharmacy Advisory Service.
abstract: BACKGROUND
  Clarity and accuracy of the pharmacy aspects of cancer clinical trial protocols is essential. Inconsistencies and ambiguities in such protocols have the potential to delay research and jeopardise both patient safety and collection of credible data. The Chemotherapy and Pharmacy Advisory Service was established by the UK National Cancer Research Network, currently known as National Institute for Health Research Clinical Research Network, to improve the quality of pharmacy-related content in cancer clinical research protocols. This article reports the scope of Chemotherapy and Pharmacy Advisory Service, its methodology of mandated protocol review and pharmacy-related guidance initiatives and its current impact.
  
  
  METHODS
  Over a 6-year period (2008-2013) since the inception of Chemotherapy and Pharmacy Advisory Service, cancer clinical trial protocols were reviewed by the service, prior to implementation at clinical trial sites. A customised Review Checklist was developed and used by a panel of experts to standardise the review process and report back queries and inconsistencies to chief investigators. Based on common queries, a Standard Protocol Template comprising specific guidance on drug-related content and a Pharmacy Manual Template were developed. In addition, a guidance framework was established to address 'ad hoc' pharmacy-related queries. The most common remarks made at protocol review have been summarised and categorised through retrospective analysis. In order to evaluate the impact of the service, chief investigators were asked to respond to queries made at protocol review and make appropriate changes to their protocols. Responses from chief investigators have been collated and acceptance rates determined.
  
  
  RESULTS
  A total of 176 protocols were reviewed. The median number of remarks per protocol was 26, of which 20 were deemed clinically relevant and mainly concerned the drug regimen, support medication, frequency and type of monitoring and drug supply aspects. Further analysis 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 content of cancer clinical trial protocols is feasible and exposes many undetected clinically relevant issues that could hinder efficient trial conduct. Our service audit revealed that the majority of suggestions were effectively incorporated in the final protocols. The refinement of existing and development of new pharmacy-related guidance documents by Chemotherapy and Pharmacy Advisory Service might aid in better and safer clinical research.
authors: Ageing & Cancer Research Cluster, Centre for Positive Ageing, University of Greenwich, London, UK Department of Adult Nursing & Paramedic Science, Faculty of Education & Health, University of Greenwich, London, UK Cancer Centre, General Hospital Groeninge, Kortrijk, Belgium P.Debruyne@greenwich.ac.uk Philip.Debruyne@azgroeninge.be.
authors: Philip R
authors: PR
authors: Debruyne
authors: Department of Molecular and Clinical Cancer Medicine, University of Liverpool, Liverpool, UK.
authors: Philip J
authors: PJ
authors: Johnson
authors: Ageing & Cancer Research Cluster, Centre for Positive Ageing, University of Greenwich, London, UK Cancer Centre, General Hospital Groeninge, Kortrijk, Belgium.
authors: Lies
authors: L
authors: Pottel
authors: Pharmacy and Medicines Management, University College London Hospitals, London, UK.
authors: Susanna
authors: S
authors: Daniels
authors: Leeds Teaching Hospitals NHS Trust, Leeds, UK.
authors: Rachel
authors: R
authors: Greer
authors: Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK.
authors: Elizabeth
authors: E
authors: Hodgkinson
authors: Pfizer Oncology UK, Tadworth, UK.
authors: Stephen
authors: S
authors: Kelly
authors: Ageing & Cancer Research Cluster, Centre for Positive Ageing, University of Greenwich, London, UK Cancer Centre, General Hospital Groeninge, Kortrijk, Belgium.
authors: Michelle
authors: M
authors: Lycke
authors: St George's Hospital Healthcare NHS Trust, London, UK.
authors: Jens
authors: J
authors: Samol
authors: Sandwell and West Birmingham Hospitals NHS Trust, West Midlands, UK Pharmacy and Therapeutics, University of Birmingham, Birmingham, UK.
authors: Julie
authors: J
authors: Mason
authors: Wessex Clinical Senate & Strategic Networks, NHS England, Southampton, UK.
authors: Donna
authors: D
authors: Kimber
authors: NCRI Clinical Studies Groups, London, UK.
authors: Eileen
authors: E
authors: Loucaides
authors: MRC Clinical Trials Unit, University College London, London, UK.
authors: Mahesh Kb
authors: MK
authors: Parmar
authors: NIHR CPAS, National Institute for Health Research, Clinical Research Network Cancer Coordinating Centre, Leeds, UK.
authors: Sally
authors: S
authors: Harvey
mesh_terms: D000970:Antineoplastic Agents / Q000592:standards*; D002985:Clinical Protocols / Q000592:standards*; D003253:Consultants; D006801:Humans; D009369:Neoplasms / Q000188:drug therapy*; D011785:Quality Assurance, Health Care / Q000458:organization & administration; D012107:Research Design / Q000592:standards*; D012189:Retrospective Studies; D006113:United Kingdom
chemical_list: D000970:Antineoplastic Agents
keywords: Chemotherapy; cancer; clinical trials; pharmacy aspects; quality control