Adaptive by Design Clinical Trials

Good study design includes thoughtful planning and involves bringing subject matter experts, like statisticians, in early. Statisticians can take existing or historic trial data for a particular disease area and create hypothetical scenarios that can inform the shaping of a tighter, better-designed trial. Good planning hones each aspect of a trial making it responsive, integrative of candidate data, and improves return on investment.

Good design equals good data.

How do we launch a trial that is good by design? By making it adaptive. An approach to clinical trials popularized in the mid-1990s, Adaptive-By-Design allows for adjustments and modifications during the clinical trial, making the study responsive in real-time.

Trial adaptations designed to allow stopping before the planned end help sponsors quickly learn if the therapy is going to fail. The principle is: “if you are going to fail, fail early.” Early stopping of inefficacious treatments is ethical and reduces costs.

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