Webinars >>FDA Regulations>>Adaptive Trials
FDA Approved Adaptive Clinical Trials: Smart Trial Design for Drug, Biologics and Devices
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Although adaptive clinical trials have been around for more than 15 years, confusions about critical practical aspects are common. Most Phase 2 and even Phase 3 trials could benefit from adaptive design whereby the trial can be modified mid-stream to increase the odds of getting the desired outcome. The key differentiator of adaptive trials is the fact that such modifications are prospectively planned and are based on the data collected from within the trial. The trial may benefit enormously if it can be modified based on mid-study new information. FDA and other regulators have allowed and even encouraged sponsors to use smart trial design that reduces the odds of failure while maintaining the scientific integrity of the 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 atte​nd:
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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.
Areas Covered in the Session:
  • 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 will benefit:

The following individuals or disciplines will benefit from attending this Webinar:
  • 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
Date: May 13, 2019
​Time: 12 PM EST
​Duration: 60 Minutes

Speaker
Mukesh Kumar, PhD, RAC,
Brij Strategic Consultations
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For additional information on this webinar, please call 410-501-5777 or email: info@fdamap.com