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

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Clinical Development and Trial Design - Developing a Coherent Approach From Beginning to End
Clinical Development
and Trial Design Developing a
Coherent Approach
From Beginning to
End
Report Description
A good clinical development plan will ensure success throughout the product lifecycle.
In today’s 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.
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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.
Report Description
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.
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Please Note: This product is delivered as a zip file
Report Description
Scope
• 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
Report Description
Key Reason 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.
Table Of Content
• Executive summary
• Methodology
• 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
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Table Of Content
• the clinical trial protocol
• the trial objective
• superiority designs
• patient population selection
• trial endpoints
• logistical issues
• site selection
• communication
• Recent developments in clinical studies and approval processes
• the LPAD pathway
• approval trends in oncology
• Appendix
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United States

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