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.
Merging Phase I & Phase II Clinical Trials: Adaptive Trial
"At the trial design phase, sponsors and CROs are taking more of a portfolio, rather than a study view, and looking at new clinical trial designs, such as adaptive trials
, to help identify promising drug candidates earlier and discontinue the development of drugs that are unlikely to be approved or will have reimbursement challenges," said Dr.
"Aptiv's adaptive trial
capabilities, combined with our existing technology platforms, such as ICONIK and Firecrest, will further differentiate our services and help our customers take time and cost out of the development process," said Dr.
The company said that the adaptive trial
design enables it to transition seamlessly to the Phase III portion of the trial after completion of the Phase II portion.
This is a particular boon to adaptive trial
designs, but has smoothed and streamlined all the trials we are conducting."
Among the latest industry trends: adaptive trial
designs dominate development programs and healthcare reform is bolstering outcomes research activities; despite recent regulatory initiatives, biosimilar development for the U.S.
There is also increased sponsor demand for adaptive trial
designs and biosimilar services.
Ellis will lead project management efforts with a focus on practices and methodology for adaptive trial
implementation and execution.
Unmet medical needs, market demands, the constant pursuit of new mechanisms of action, innovative biological approaches, adaptive trial
design, and personalized medicine.
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