Academic journal article Journal of Research Administration

Application of Standard Project Management Tools to Research - A Case Study from a Multi-National Clinical Trial

Academic journal article Journal of Research Administration

Application of Standard Project Management Tools to Research - A Case Study from a Multi-National Clinical Trial

Article excerpt

Abstract

PRINCE2, which stands for Projects in Controlled Environments, is a project management method covering the organisation, management, and control of projects and is widely used in both government and commercial IT and building projects in the UK. This paper describes the application of PRINCE2 to the management of large clinical trials (specifically, of a Phase III trial of a candidate microbicide to prevent vaginally acquired HIV infection). It reviews the challenge of ensuring that the project management tools add value to the project overall and are not perceived as an overly administrative burden. It reviews the requirement for high level summary reports for use by an executive committee and funding bodies, highlighting the reasons for taking this approach - in particular, not only to manage the science, but to link expenditure to activities at geographically separate trial sites and to key performance indicators, and to provide tools for monitoring risks and possible re-alignment of budgets to reflect changing activities and outputs by collaborators. The paper considers the wider costs and benefits to researchers and funders of taking this approach and explores implications for research administrators and managers at institutions involved in large, complex collaborative research projects, whether clinical or not.

Key Words: Project management tools, PRINCE2, clinical trial, microbicide, Microbicides Development Programme (MDP), financial controls

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 (DFlD) 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 HI 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. …

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