Clinical trial methodology that allows trial design modifications to be made after patients has been enrolled in a study, without compromising the scientific method and integrity of data.

It also Empowers sponsor to response to data collected during the Trial like Modifying sample size, dropping a treatment arm, balancing Treatment assignments using adaptive randomization or simply stopping a study early for success or failure.

Patients randomized to treatment arms based on the response to treatment of previous patients. Real-time safety & efficacy data incorporated into randomization strategy and Play-the-winner: Assignment of patients to treatment arms that resulted in fewer adverse events or better efficacy

Advantages:

Cost reduction: Stopping unsuccessful trials earlier, identifying successful trials sooner, dropping unnecessary treatment arms or     determining effective dose regimes faster

Reduction in lead time between phases, especially II and III:

Reduced time to market

Improved patient safety

Reduced exposure to unsuccessful treatment arms    

Increased access to effective treatment arms