In the quest to increase the efficiency of clinical trials, adaptive design methods have arisen, with support from the FDA draft guidance. Adaptive trial designs use accumulating data to modify trials under progress without affecting the integrity of the trials. They allow sponsors to adjust certain parameters such as dosage, subject population, or sample size in consideration of statistically significant safety or efficacy data.
The goals are to accelerate clinical development and improve its efficiency, better target experimental drugs to responsive patient groups, and reduce the number of patients exposed to inappropriate or ineffective therapies.
Why Should You Attend:
A major concern among many drug companies is that patient resources on therapies and doses are potentially wasted and are unlikely to be successful. Adaptive designs are created to prevent waste, speed up medical device development and increase accuracy in identifying the appropriate device to be used.
The adaptive approach also allows for addressing questions that could never be addressed in a balanced randomised trial.
The FDA recently issued a draft guidance for industries regarding the use of adaptive designs in the regulatory setting, focusing on medical device trials.
Adaptive design differs from a traditional design in that it uses accumulating results in the trial to modify the trial’s course. All adaptations should be completely specified in advance of the trial, at the design stage, so that operating characteristics can be calculated.
Areas Covered in this Webinar:
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.
• 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
Who Will Benefit:
• 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
Danielle DeLucy, MS, is an Independent Consultant to the Biologics and Pharmaceutical Industries.
Danielle DeLucy, is owner of ASA Training and Consulting, LLC which provides Pharmaceutical and Biologics based companies with training and quality systems assistance in order to meet Regulatory compliance.
Prior to this role, Danielle has been in the industry for 15 years serving in numerous Quality Management Roles, such as the Director of Product Quality, the oversight of Sterility Assurance practices and provided QA oversight of numerous filling and packaging operations.
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