Adaptive Trial Model

An adaptive clinical trial defines a clinical trial that evaluates a medical device or treatment by observing possibly other measures, such as side-effects on a prescribed schedule, and modification of the parameters of trial protocol in accordance with those observations. Generally, the adaptation process continues throughout the trial, as prescribed in the trial protocol. Modified dosage, sample size, drug undergoing trial, patient selection criteria are included.  Trials become an ongoing process which regularly adds therapies and patient groups as more information is gained.  The trial protocol set before the trial begins and the protocol specifies before the adaptation schedule and processes.

  • Estimating treatment effects
  • Trial planning
  • Maintaining trial conduct and integrity

 


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