During the planning and design phase, GBM AGILE is "crowdsourcing" knowledge from a large number of international leaders in GBM basic and clinical research and using that knowledge to inform the design of a new-generation adaptive trial
that will learn from every patient that enters the trial.
He assists companies designing and implementing adaptive trial
methodologies that improve device and drug development programs by reducing clinical trial cycle times and optimizing late stage trial success rates.
The operation of such IDMC in adaptive trial
is often challenging, as compared to its operation in a conventional trial.
Alternatively, the FDA can re-vamp the entire clinical trial system and adopt an adaptive trial
By using an adaptive trial
design, we may have the potential to enroll fewer patients than with a traditional approach, thus potentially accelerating the transition into phase 3 studies.
Icon's excellence in execution, geographic reach, and shared focus on innovation will position the combined entity as the go-to service provider for design and execution of adaptive trials
for drug diagnostic and medical device companies in a fast-growing market.
Additionally, ClinPhone RTSM has been used in more than 250 studies using covariate adaptive randomization techniques and 160 studies using adaptive trial
According to Aptiv officials, the use of adaptive trial
design for medical devices is growing, as is support from the FDA.
Industry Standard Research (ISR) today launched a new market research report titled "Adaptive Trial
Market Dynamics" providing clinical operations and regulatory professionals with new insights into the industry's adoption and use of adaptive trials
designs enable biotech companies to refine their hypotheses and reallocate R&D dollars in real time based on data generated in the clinic.
Nicholls will provide an overview of adaptive trial
designs and comment on some of the current regulatory and logistical perspectives of implementing such trials on a global basis.
FACTS is a powerful tool that will enhance our ability to deliver flexible, efficient adaptive trial
designs for our clients in less time than we could previously," said Susan Atkinson, Ph.