Adaptive Clinical Trials

Adaptive clinical trial designs have been widely utilized in the development of medical devices, and the lessons gained are now being applied to the development of drugs.

The adaptive design may help decrease the number of patients enrolled in a study and the total number of trials. It may potentially result in more illuminating trial findings. Adaptive design’s increased flexibility may help improve its acceptance among stakeholders.

Adaptive design is especially advantageous for ensuring that clinical safety and effectiveness studies are properly controlled. The adaptive design may also be advantageous in early-phase studies, exploratory trials, and subsequent trials performed to meet post-marketing obligations. Using adaptive design in an exploratory environment enables assessing a wide variety of dosages, regimens, and demographics, with the option of discontinuing the study of inferior options. Apart from providing more flexibility, this method offers the ethical advantage of subjecting fewer individuals to inferior therapies.

Clinical trials with an adaptive design may have significant benefits over trials with a conventional design, including the ability to make prospectively planned changes to specific aspects of the research design and produce more informative and efficient study results.