The Clinical Development Plan

It is impossible to consider clinical trial protocol design in isolation. All clinical protocols should be written after a clinical development plan has been agreed by the diverse membership of the clinical development team. The clinical development plan should itself follow the construction of an hypothetical drug label (see Chapter 29). The goals of such a plan might be as limited as to provide for the start of Phase II, or as complex as mapping an entire route from first-in-man studies to product registration. The path from the present status to the overall goal can then be understood. It may be added that, within a large company, this is also a good way for clinical and marketing departments to communicate.

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