Objectives (1) To scope pharmacy clinical trial services in Birmingham and Black Country and the West Midlands. (2) To devise a strategy to deliver services with best use of resources.
Topical Research Networks have been set up to increase quality research in NHS. Medicines for Children Research Network is dependent on hospital pharmacies having the capability to run CTIMPs (Clinical Trials of Investigational Medicinal Products). Nationally Pharmacy has been identified as a block, hence the need to scope the underlying local situation and identify what is needed to improve pharmacy clinical trial delivery.
Methods Review of survey of Chief Pharmacists in the North West1 used as basis for West Midlands Chief Pharmacist Questionnaire in August 2009.
20 semi structured interviews of key stakeholders in Birmingham and Black Country Comprehensive Local Research Network carried out between June and September 2009.
Results The North West survey identified the issues and proposed a model for central support but there was no mention of outcome targets or evidence based management. 30 trusts surveyed, 66% response rate. With the West Midlands Chief Pharmacist Questionnaire 18 trusts were surveyed, 22% response rate. This indicated that a wider scoping method was needed.
The findings from the interviews with Birmingham and Black Country Comprehensive Local Research Network key stakeholders indicated inadequate staffing, recruitment problems with insufficient training and education available. Pharmacy clinical trial staff were not integrated into the research infrastructure. The funding mechanisms were unclear. Insufficient storage facilities and lack of aseptic capacity for clinical trials were identified. Standards for running clinical trials were variable.
Conclusion The existing system is dysfunctional and a new co-ordinated strategy for delivering clinical trials, expert input and associated funding is needed across the region.
Short term strategy: A pharmacy clinical trial network is needed with a lead pharmacist, lead clinical trial centre and management committee. Finance needs to be sufficient and targeted to support staffing. Existing centres need assistance with legislation and guidance, with access to a knowledge base and training. New centres need to be developed. Communication needs improving so that pharmacy liaises with R&D. The profile of clinical trials as a specialty needs raising with Directors of Pharmacy.
Medium term strategy: Quality of clinical trial delivery depends on processes with site audits to inform on standards. For capacity planning the development of clinical trial units on each site with the necessary facilities is needed. To provide staffing the hub and spoke mechanism will operate with CLRN funded staff contributing back to the centre.
Long term strategy: In order to improve recruitment and retention a career structure for CT staff needs to be set up with input into education both at universities and colleges with designated training and competencies.