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. Conclusion 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.

Identifying options for oncology therapy regimen codification to improve standardization—combined results of an expert panel and a review

“…This template aids investigators in providing unequivocal information on treatment regimens through use of a standardized format. In a publication outlining the work of CPAS, data from 176 clinical trial protocols that were reviewed were compiled resulting in a summary of options to leverage standardization concerning drug‐related content 21 …”

“…In a publication outlining the work of CPAS, data from 176 clinical trial protocols that were reviewed were compiled resulting in a summary of options to leverage standardization concerning drug‐related content. 21 …”

“…Include the route of administration (eg IV, PO,…) and the duration (eg 15 min, 46 h,…) of the infusion together with the shape (eg continuous infusion, short infusion or bolus) 11,21 , experts…”

“…Preferred reporting item for systematic reviews and meta-analysis (PRISMA) flow diagram Current options to improve standardizations in regimen codification and nomenclature for chemotherapy treatments in healthcare information systems and published guidelines. Imaginative names of regimens (eg FEC, TAC) based on abbreviations, INN names are mixed with brand names Do not abbreviate drug names and use only complete approved generic drug names6,7,9,11,13,21 , experts…”