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.
BENEFITS: Adaptive trials could allow for significant reduction in 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.
Get your hands on all the regulations, potential risks, various statistical considerations along with the logistical implications and practical use of adaptive clinical trial design with our expert presenter Dr. Mukesh Kumar. Case studies from drugs, biologics and medical device clinical trials will be used to highlight common errors and acceptable solutions.
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.
Here are a few highlights of the session:
Areas Covered in the Webinar:
Who should attend?
Dr. Mukesh Kumar is a Washington DC-based consultant in regulatory affairs and quality assurance for manufacturers and developers of FDA-regulated products. He leads the Regulatory Affairs and Quality Assurance departments at Amarex, a full service pharmaceutical product development company based in Germantown, MD (www.amarexcro.com). His key expertise is in regulatory affairs, clinical trials, and multi-national project management for medicinal and diagnostic products. He has been involved in about 100...
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