2014 - FDA Approval of Adaptive Clinical Trials: Practical Tips to Maximize Benefits from Smart Trial Design

Instructor: Mukesh Kumar
Description:
Mid-way during an ongoing clinical trial, critical information may be anticipated, that could potentially influence the outcome of the entire trial. The trial may benefit enormously if it can be modified to address mid-study new information. A clinical trial design that allows such a modification is called an Adaptive Clinical Trial. Adaptive trials could allow for significant reduction in the cost and time to market for the products under development, and can also increase the probability of success of the development program. Such trials can be employed for all kinds of FDA-regulated products. This seminar will discuss key statistical and regulatory strategies for adaptive clinical trials based of guidance from FDA and case studies.
Why Should you Attend:
Adaptive clinical trials are getting increasingly common across all product types due to the obvious advantages over conventional trials. Even pivotal studies could be of adaptive design. However, there are critical issues with design, statistical justification, logistics, and site management for an adaptive trial that could lead to a failed study if not addressed appropriately. This webinar will discuss the regulations, statistical considerations, logistical implications and practical applications of adaptive clinical trial design. Case studies from drugs, biologics and medical device clinical trials will be used to highlight common errors and acceptable solutions.
Objectives of the Presentation:
Key US and EU regulatory requirements for adaptive clinical trials.
Building a rationale for adaptive trial design
Logistics of adaptive clinical trials: Do’s and Don’ts
Differences in using adaptive trials for drug, biologic and medical devices
Case studies using real-life examples
Who can Benefit:
This webinar will provide valuable information to:
Manufacturers of FDA regulated products: Drug, Medical Device and Biotech Companies
Clinical trial Professionals such as project managers, CRAs, medical writers
Senior Management for companies developing new products for US market
Regulatory Affairs Professionals
People investing in FDA-regulated products intended for the US market
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