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institution may include pharmacists, laboratory staff, and ethics committees. The purpose of this outline is not to itemize, exhaustively, all the different people involved (the reader will already know these) but to highlight the potential complexity of the negotiations required. This complexity is a key feature of clinical trial projects and one in which they differ from research and development in many other industries. Exacerbating this complexity is the minimal control the project manager has over some external areas, such as patient recruitment or ethics committee approval. |
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2.
The Customer or Client |
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One key person not shown in Fig. 1 is the internal client. Many companies are now operating a customer-oriented culture, which helps to clarify for whom any work is being done. Project management starts with the customer/client, who issues an initial requirement, and it is vital to be clear as to who this is. For a registration package of studies, the client could be the regulatory department, but might it not also be the marketing department, which will have to use the data? Other potential clients are the regulatory authorities, who issue specifications as to how the data should be submitted, the investigators who will be using the drug, and let us not forget the patients! Thus, the more we look, the more complex the situation appears, with great potential for communication breakdown and project failure. Later in this chapter, we will look at ways of managing this web of different skills, interests (and possibly even objectives). |
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Contract research organizations (CROs) have some advantages because they are usually clear as to who their client is. This is not because it is always obvious from the start, but they have to get it clear, or any negotiation is useless. The problems really occur when it is found later that the apparent client lacks the authority for key decisions. So careful review of plans and especially decision points is needed, and the correct responsibility must be assigned to each stage. |
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3.
Modeling Reality in Project Planning |
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So, how can we plan realistically? How can we rely on the information we obtain from all of these people and build it into an effective plan? Let us start with the client, who issues the requirements for the clinical trial(s), and uses the results. If requirements were always clear to everyone, planning would be far easier than it often is, but to a great extent, the time-honored methodology for protocol development does not always give good results. Consider Fig. 2, which shows a typical flow chart, distilled from various companies' standard operating procedures (SOPs). What, for ex- |
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