Supporting MCRN research through improving clinical trial delivery by hospital pharmacies

Norton, C.; Sinclair, A.; Marriott, J. F.
April 2011
Archives of Disease in Childhood -- Fetal & Neonatal Edition;Apr2011, Vol. 96 Issue 4, pe1
Academic Journal
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.


Related Articles

  • Researchers see a need for speed in EU trial approvals. Cressey, Daniel // Nature Medicine;Aug2008, Vol. 14 Issue 8, p794 

    The article reports that the legislation which is designed to assist harmonize research rules across the Europe has failed to improve the time it takes for clinical trials to receive approval. According to the article, there are some experts argue that the measures known as the European Clinical...

  • Caring for the failing heart. Smoot, Laura Carter // Drug Topics;6/16/2008, Vol. 152 Issue 7, p44 

    The article reports on how to care for the failing heart. It describes chronic heart failure (HF) as a condition in which the heart loses its ability to meet the metabolic demands of the body due to insufficient cardiac output. It focuses on HF and provides an overview of the disease, reviews...

  • Establishing Rules of the Road for Pharmaceutical Representatives. Evans, Jason // Family Practice Management;Mar2005, Vol. 12 Issue 3, p10 

    Comments on the need to establish rules for pharmaceutical representatives. Importance of representative to provide useful information on new drugs and new study results; Possibility of employing high-pressure sales techniques; Significance of medical communication.

  • Role of the Practitioner-Researcher in Pharmacy Practice. Grzeskowiak, Luke E.; Roberts, Greg; Bell, J. Simon // Journal of Pharmacy Practice & Research;Mar2012, Vol. 42 Issue 1, p5 

    No abstract available.

  • The Slow but Steady Pace of EU GCP Rules. O'Donnell, Peter // Applied Clinical Trials;Sep2004, Vol. 13 Issue 9, p30 

    Discusses the European Union's (EU) raft legislation containing good clinical practice (GCP) rules in the conduct of clinical trials on medicinal products for human use. Requirements for authorization of manufacturing or importation of medicinal products; Provision designed to ease requirements...

  • Revisiting the European Union Directive in CEE. Capala-Szczurko, Iwona // Applied Clinical Trials;Mar2006, Vol. 15 Issue 3, p56 

    No abstract available.

  • What Must Research Subjects Be Told Regarding the Results of Completed Randomized Trials? Markman, Maurie // IRB: Ethics & Human Research;May/Jun2004, Vol. 26 Issue 3, p8 

    The article discusses results of completed randomized trials. Federal research regulations require investigators to inform research subjects of "significant new findings developed during the course of the research which may relate to the subject's willingness to continue participation." However,...

  • Calendar of Events.  // Applied Clinical Trials;Jan2005, Vol. 14 Issue 1, p62 

    Presents schedule of events related to clinical trials and pharmaceutical industry compiled as of January 2005. Auditing Techniques for Clinical Research Professionals; New Medicines Legislation; Developing Clinical Study Budgets.

  • Clinical Trial Opportunities in China. Liang Kong // Applied Clinical Trials;Apr2007, Vol. 16 Issue 4, p58 

    The article focuses on the clinical trial opportunities in China and the challenges faced by multinational companies conducting the trials. It has been noted that clinical trials is a new phenomena in the country. There are some local practices that differ from other countries, which could...


Read the Article


Sorry, but this item is not currently available from your library.

Try another library?
Sign out of this library

Other Topics