FDA Approved Adaptive Clinical Trials: Smart Trial Design for Drug, Biologics and Devices
Date: March 3, 2025
Time: 12 PM EST
Duration: 60 Minutes
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
Speaker: Mukesh Kumar
PhD, RAC | CEO, FDAMap
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Webinar Fee
Prices are in US Dollars.
The registration fee includes: The live webinar & all related course materials.
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