A Clinical Development Plan (CDP) is a description of the scheduled clinical trials that will be carried out in order to assess the safety and effectiveness of a new drug. It outlines the planned development process of a compound (or set of compounds) based on the target product profile (TPP). Its purpose is to take the product down the right path from the start by carefully planning the clinical trial program.
The CDP typically includes a rationale for the development, both scientific and commercial; the prospective patient package insert/summary of product characteristics; the clinical trials plan (trials that will provide data to support the desired claims); the timeline and costs of the trials (ie, strategic planning of the trials); and regulatory considerations.
The CDP and TPP need to be developed early. Describing the TPP can be seen as part of the CDP discussions. The CDP is a complex document and requires input from different functions (marketing, preclinical, production, pharmacovigilance, regulatory, …). Important cross-functional decisions and strategies need to be made in the early stages, as these will have direct consequences on later stages of the program.
The CDP is a living document and needs to be adapted as results of studies become available. The CDP and TPP need to be kept aligned during the development program.
The Medical Writer can manage and coordinate the document development process (of new or updated CDPs) and can help to generate a clear, well structured, and coherent document.