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Clinical Development and Trial Design - Developing a Coherent Approach From Beginning to End

Published: Apr 2015 | No Of Pages: 48 | Published By: CBR Pharma Insights

A good clinical development plan will ensure success throughout the product lifecycle.

In todays cost constrained environment, the clinical development plan can help refine the trial process, encouraging cost and time efficiencies and ensuring a streamlined process throughout.

The clinical development plan ties together all aspects of product development, enabling an incorporated approach to the clinical and commercial rationale of product development.

A variety of approaches should be adopted to ensure a robust clinical development plan is developed. Early initiation of the clinical development plan is critical for the execution of a successful product development process.

A proactive approach to the processes and objectives encompassed in the clinical development plan must be adopted..

The report, Clinical Development and Trial Design - Developing a Coherent Approach From Beginning to End, was written to provide insights & analysis to teams and companies to support getting a product to market quickly and successfully. This report will help ensure development teams are on top of all necessary components of product development while providing suggestions which enable them speed the process to a successful launch.


  • Devising a clinical development plan key considerations
  • Review of clinical trial design stages protocol, objectives, patient population selection, endpoints, site selection and issues
  • Recent developments

Key Reasons to Purchase

  • Understand what a clinical development plan consists of and how creating one at an early stage of new pharmaceutical product development will contribute to the overall success of the trial program and eventual commercial launch
  • Provides an overview of the recommended approaches to the range of activities that should be undertaken to ensure all aspects of clinical development are addressed
  • Enables you to understand the interaction between the commercial and scientific members of the clinical development team and how to ensure clear communication and ongoing cooperation throughout the clinical trial process
  • The report provides in-depth analysis of key aspects of clinical trial design, examining how the right endpoints, objectives and design are critical to guarantee eventual regulatory and reimbursement approvals
  • Benefit from up-to-date case studies and analysis examining changes in clinical studies, in particular in the fast-moving oncology therapy area, and how new initiatives are breathing life into the stagnant antibacterials market

Executive summary
Clinical development plans
Key considerations for a clinical development plan
clinical communications
internal versus external resourcing
regulatory relationships
scientific and commercial cooperation
health economics
Clinical trial design
the clinical trial protocol
the trial objective
superiority designs
patient population selection
trial endpoints
adaptive trial design
logistical issues
site selection
Recent developments in clinical studies and approval processes
the LPAD pathway
approval trends in oncology

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