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- W1487661421 abstract "Introduction Although the pharmaceutical industry has well-developed project management methodologies for research, it is unusual for academic researchers working in the education and public sectors to do so. The discipline that these tools impose can appear alien initially and often require cultural change for the potential value they can bring to be recognised. This paper examines the experience of introducing a standard project management tool, PRINCE2, to the management of a large Phase III clinical trial, the Microbicides Development Programme (MDP). Phase III clinical trials are usually undertaken by the pharmaceutical industry. Somewhat unusually, the MDP is publicly funded and managed by a partnership of academic bodies. Funding is provided by the UK Department for International Development (DFID) and the programme is coordinated by the Medical Research Council Clinical Trials Unit, UK and Imperial College London, UK. The trial sites themselves are in Africa. The complexity of this particular trial, and the need to communicate and monitor progress against budget in a standard format to the funder, DFID, prompted senior academic staff to modify their approach to management and reporting through adopting elements of PRINCE2. This has proved beneficial for both the trial team and DFID. The paper describes what was done in the MDP case and discusses the costs and benefits of adopting a similar approach more widely in conducting academic-led clinical trials. The Microbicides Development Programme The Microbicides Development Programme (MDP) is a partnership to develop vaginal microbicides for the prevention of HIV transmission, funded by the UK Department for International Development (DFID) and the UK Medical Research Council, and coordinated by the Medical Research Council Clinical Trials Unit, UK and Imperial College London, UK. The central goal of the Partnership is to complete a Phase III trial of candidate microbicides in Africa. Phase III trials are randomised controlled trials on large patient/healthy volunteer groups (often enrolling several thousand individuals), and are aimed at definitively assessing the efficacy of a new therapy or prevention. Phase III trials are invariably expensive, time-consuming and complex to design and run. These trials look at whether the new treatment works and at any side effects it may cause. The MDP budget is GBP 42M (USD 75M) and involves thirteen principal scientific partner institutions, six of which are African. A large number of scientists and clinicians are involved in programme management functions in addition to their own areas of particular expertise. There are also a number of people focusing on specific areas, such as trial management and communication. Given the size of the management burden of a Phase III clinical trial and the need to communicate progress in a standard format to the funder, DFID, in a way that would reflect both the customary approaches to trial management and DFID's usual approach to reporting on projects (not designed specifically for clinical trials), senior academic staff opted to adopt an approach to project management based on PRINCE2 methodology. Features of PRINCE2 PRINCE is a structured method for achieving effective project management that has evolved in the UK. It was first established in 1989 by the UK Central Computer and Telecommunications Agency as a standard to be used for all government IT projects, and was subsequently developed as an approach to project management for all projects. Since 1996 it has been a standard requirement that UK public sector projects are run using this version of the approach, PRINCE2. Key features of the PRINCE2 approach include: 1) a clear business case, which sets out the aims of the project; 2) a defined and measurable set of products or results, together with the activities to achieve them; 3) defined resources linked to activities; and 4) an organisational structure, with defined responsibilities to manage the project (UK Office of Government Commerce) (Figure 1). …" @default.
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- W1487661421 date "2007-09-22" @default.
- W1487661421 modified "2023-09-27" @default.
- W1487661421 title "Application of Standard Project Management Tools to Research--A Case Study from a Multi-National Clinical Trial." @default.
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