Clinical Development Plan (CDP)
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A Clinical Development Plan (CDP) is a research plan for a clinical study.
- AKA: Clinical Trials Plan.
- Context:
- It can include multiple Clinical Trials conducted in different patient populations.
- It can outline a regulatory strategy for obtaining approval from regulatory agencies.
- It can include a marketing strategy for launching the product.
- It can specify timelines for each stage of the development process.
- It can outline the resources required to develop the product.
- …
- See: Target Product Profile (TPP).
References
2023
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- A Clinical Development Plan (CDP) is a comprehensive plan that outlines the strategy and steps for the development of a new medical product or intervention, including clinical trials, regulatory strategy, marketing strategy, project timelines, and resource allocation.
- Characteristics:
- It can include multiple Clinical Trials conducted in different patient populations.
- It can outline a regulatory strategy for obtaining approval from regulatory agencies.
- It can include a marketing strategy for launching the product.
- It can specify timelines for each stage of the development process.
- It can outline the resources that will be required to develop the product.
- Related terms: Target Product Profile (TPP), regulatory approval, medical product, clinical trials, marketing strategy, resource allocation.
2018
- (Singh, 2018) ⇒ Gursharan Singh. (2018). “Target Product Profile and Clinical Development Plan.” In: Pharmaceutical Medicine and Translational Clinical Research, pp. 65-80 . Academic Press,
- ABSTRACT: The ultimate aim of a drug development program is to obtain regulatory approval with an optimal label (prescribing information) that which ensures commercial success. Target Product Profile (TPP) is the intended profile of a pharmaceutical/biotechnology product or technology, developed based on cross-functional discussions. The regulatory TPP is organized according to key sections in a drug label, while an abbreviated version of the TPP is used for commercial/business communications including net product value calculation. Once the TPP is finalized, the clinical development is planned to meet the criteria specified in the TPP. The Clinical Development Plan is the blueprint of the entire clinical research strategy of a drug which defines the critical path for the clinical program including development assessment and decision points and the project resource (personnel and budget) estimates. This chapter covers the basic concepts of clinical development including phases of development, study endpoints, design configurations, control groups, etc., as well as the content of the Clinical Development Plan.
2005
- (Julious & Swank, 2005) ⇒ Steven A. Julious, and David J. Swank. (2005). “Moving Statistics Beyond the Individual Clinical Trial: Applying Decision Science to Optimize a Clinical Development plan.” Pharmaceutical Statistics 4, no. 1
- ABSTRACT: This paper describes how simple decision science techniques can be used to optimize the clinical development plan for a given compound. Using a case study from the stroke therapeutic area it is shown how methods such as decision trees can be utilized to describe, and adjudicate on, individual development plans. Terminology pertinent to decision sciences is described and areas where it is recommended statisticians should focus are highlighted.