US and EU regulatory requirements for adaptive clinical trials, its rationale, logistics and differences for drug, biologic and medical devices

1. Overview
Adaptive Designs for Medical Device Clinical
Studies
Date: Wednesday, October 5th, 2016, Time: 01:00 PM EDT | 10:00 AM PDT
Duration: 60 Minutes
Speaker: Danielle DeLucy
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arisen, with support from the FDA draft guidance.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The FDA recently issued draft guidance for industries regarding the use of adaptive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.
Register Now

2. Areas covered in the 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.
Learning objective
 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
Speaker profile
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.
Danielle began her QA career as a Quality Control Pharmaceutical Microbiologist at a
contract laboratory where she performed various tests for their clients. In the years after,
she has held positions in the Quality management arena while increasing her

3. responsibility. She has helped to lead many Regulatory Health Inspections and was
instrumental in the coaching process of her peers prior to any inspection.
For more information, contact support @complianceglobal.us