Clinical Trials: The Clinical Development Plan Pt 1


Dr Michael Silverman, principal at BioStrategics Consulting Ltd, talks about a second important strategic element of pharmaceutical development in this blog, and that is, the formulation of a Clinical Development Plan. This is a vital road map defining how the 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 preparation of a prospective patient package insert (PPI), a key strategic document in developing a new drug for market approval and acceptance. This week, Dr. Silverman discusses a second essential document in support of a compound’s strategic goals, namely, the Clinical Development Plan (CDP). Not to be confused with the FDA’s IND section entitled “General Investigational Plan” which is a short summary of the trials planned for the upcoming year, the CDP is an internal corporate management document.

While more tactically oriented than the prospective PPI, it is nevertheless every bit as strategic in that it serves key goal-setting, performance assessment, communications, and decision-making functions.  The CDP is again multidisciplinary and aspirational, while also providing the conceptual framework for the entire clinical trials program relating to the compound in question.

Components of the Clinical Development Plan

  • Scientific Rationale for Development
    • Chemical and physical composition
      • Chemical class
      • Chemical structure
      • Chemical properties
      • Formulation characteristics
      • Manufacturing plans
    • Nonclinical pharmacology
      • In vitro
      • In vivo
      • Secondary pharmacology
      • Absorption, distribution, metabolism, and excretion
      • Pharmacokinetic behavior
      • Pharmacokinetic/pharmacodynamic correlations
    • Nonclinical study
      • Toxicology results
      • Planned toxicology program (chronic, carcinogenicity, reproductive)
  • Commercial Rationale for Development
    • Clinical target(s) and descriptions of disease
    • Epidemiologic considerations
    • Unmet clinical need(s)
    • Unmet market need(s)
    • Market assumptions and projections
    • Product profiles: optimal versus minimal acceptable
    • Synergy with other company products (marketed or under development)
    • International considerations
    • Competitive situation (existing and potential)
  • Clinical Trials Plan
    • Phase 1
    • Phase 2
    • Phase 3
    • Postmarketing trials
  • For each phase
    • Proposed population
    • Scientific hypotheses and protocol objectives
    • Trial design considerations
    • Sample sizes
    • Projected resource needs
      • People
      • Costs
      • Clinical supplies
      • Third party vendors
    • Timelines
    • International considerations
  • Regulatory Considerations
    • Pre-IND meeting planning
    • IND documentation
    • Regulatory communications and meetings
    • Regulatory trends and intelligence
    • International regulatory planning
  • Strategic Planning
    • Milestones and critical information availability
    • Key decision points
    • Go/no-go criteria
    • Contingency plans
    • Partnering, licensing and other business development issues
    • Prospective patient package insert

For a copy of the Clinical Development Plan, please send an email request to mphilip@biostrategics.com

Part 2 of the Clinical Development Plan will be published next week, don’t miss it. Subscribe to the BioStrategics Consulting Ltd, blog (top right corner) .

Dr Michael Silverman is the principal clinical consultant at BioStrategics Consulting Ltd.,  a clinical development consulting company based in Marblehead, MA, with businessinterests 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 website 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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