Clinical Trials: The Clinical Development Plan Part 2


Dr Michael Silverman, principal at BioStrategics Consulting Ltd, continues the discussion this week on the formulation of a Clinical Development Plan. This is a vital road map defining how one’s product will be developed through a series of clinical trials to achieve approval and market acceptance.

In last week’s blog, Dr Silverman discussed the basic framework and components of the Clinical Development Plan (CDP) and how its preparation formed one of two essential documents in support of a new compound’s strategic goals. The other essential document being the prospective patient package insert (PPI), which helps define the characteristics required of a new drug for market approval and acceptance. Formulating a prospective PPI was summarized in a previous blog. If the prospective PPI is a description of the destination, the CDP can be viewed as the map to get there. This week, Dr. Silverman further discusses the Clinical Development Plan and how to devise the map to reach your goals.

The CDP lays out a logical sequence of clinical trials that should be conducted to generate the information necessary to support the label claims. It is noteworthy to say that creating such a document, while entailing considerable time, thought and effort on the part of all members of the development team, is extremely valuable and predictive of the success of any program. Only if the perspectives of all relevant disciplines are integrated into the development plan can the project truly reflect corporate goals.

Key Components of the Clinical Development Plan (see Part 1 for the detailed list)

  • Scientific Rationale for Development
  • Commercial Rationale for Development
  • Clinical Trials Plan
  • Regulatory Considerations
  • Strategic Planning

While it is axiomatic that every program will experience unanticipated results and meet unexpected hurdles during its lifetime, an inclusive planning process creates an organization consensus about the project’s ultimate goals and criteria for success.

The CDP is a bridge between the purely strategic asset management planning process on the one hand, and, on the other, the highly tactical scientific and operational realms of the clinical trial process. Its creation is generally spearheaded by the clinical research department, which then becomes accountable for its execution.  Clinical research professionals are responsible for ensuring that every protocol contributes to the body of knowledge specified by the prospective PPI and the CDP, and that the resulting data are expressed and communicated in a way that allows corporate decision makers to act upon them accordingly.

TO OBTAIN A FREE COPY OF THE CLINICAL DEVELOPMENT PLAN GUIDE AND/OR THE PROSPECTIVE PATIENT PACKAGE INSERT, Send an email to mphilip@biostrategics.com with your name and email address.

Dr Michael Silverman is the principal clinical consultant at BioStrategics Consulting Ltd., a clinical development consulting company based in Marblehead, MA, with business interests around the globe. Dr Silverman would be delighted to hear your thoughts on today’s blog, your experiences, or anecdotes and of course, your questions. To make comments or ask questions, click on this link.

For more information: go to my web site or send me an email at msilverman@biostrategics.com

Copyright © 2011 BioStrategics Consulting Ltd.

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About BioStrategics Consulting Ltd

BioStrategics Consulting Ltd provides a range of management-level clinical development consulting services to the pharmaceutical and biotechnology industries
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