Given that adaptive trials
are liable to misuse (for example, ad-hoc changes to rescue a poorly planned study), regulators across the world often scrutinize adaptive designs much more closely.
The second long-term solution is for the FDA to promulgate regulations that merge Phase I trials with Phase II trials and impose the requisite protocols through ah adaptive trial
ISR found that 91% of respondents indicated adaptive trials
are gaining momentum within their organizations," Schafer explained.
Aptiv Solutions, a biopharmaceutical and medical device development services company, and the leader in adaptive clinical trial design, simulation and execution, announced today that several of its thought leaders will provide new insights on the design and execution of adaptive trials
at the upcoming Drug Information Association (DIA) 2012 Annual Meeting.
The adaptive trial
group at SynteractHCR works under the direction of Dr.
Population enrichment designs offer a specific adaptive trial
methodology to study the effect of experimental treatments in various sub-populations of patients under investigation, and in the wider population.
All three companies recognize the importance of educating industry on the value and benefit of adaptive trials
and will work together on a series of joint marketing activities.
Ellis will lead project management efforts with a focus on practices and methodology for adaptive trial
implementation and execution.
AptivAdvantage(TM) is an integral part of the adaptive trial
data management process and integrates randomization, electronic data capture and drug supply management.
Cytel and Sunesis Pharmaceuticals' Experts Host Educational Session December 14, 11:00 AM EST on DMC/DSMB and Adaptive Trial
Perceptive Informatics is committed to driving the industry in using eClinical solutions to support complex adaptive trial
designs and their associated supply management challenges.
Our clinical trial experts will provide Galena with a dedicated and diverse team to manage the PRESENT trial start-up and all related clinical trial activities for global implementation, including consideration of adaptive trial
We are delighted to welcome the seasoned group of medical device and diagnostic experts from MDCI to the company, as we continue to broaden our acumen in medical device and adaptive trial
With the increasing validation of the practical innovations delivered in Cytel adaptive trial
methodologies, (detailed in this poster PDF) Cytel's work continues with numerous other oncology, CNS, metabolic and cardio-vascular biopharmaceutical developers on adaptive trial
designs in both early and late stage clinical research.
Figure 4: Types of dose finding adaptive trial
design tested by the PhRMA Adaptive Dose-Ranging Studies Working Group in 2009 30