Adaptive Clinical Trial Design

Adaptive clinical trials entail the modification of some aspect of an on-going clinical trial based on information produced during the trial.

Typically these modifications occur during the early phases of a trial and can can be used to pinpoint:

Sample size
Dosage
Safety issues
The strength of the response
The most appropriate design model

Making a modification to an on-going trial allows for smaller and far more efficient trials.

Adaptive clinical trials have seen a recent surge due to:

Advances in theory of adaptive desings
More acceptance by regulatory agencies
Advancements in electronic data capture and other software systems

Led by years of experience and experts in the field of clinical trial design, Prosoft has created a software suite for the implementation of a wide variety of adaptive clinical trial designs. Let our experts work with your team to design the most efficient trial and assist with your presentation to the FDA or other regulatory agencies.

Save time, money and resources by utilizing flexible desings for:

Group sequential analysis
Interim analysis
Sample size re-estimation