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 process.
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 Regulatory Compliance
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 design strategies.
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 methodology.
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
