Adaptive Design: More Success, Less Risk and Waste
The success of each study hinges on accurate planning estimates for key parameters, but estimates are often based on limited information. Health Decisions works with sponsors to indentify and implement safe, FDA-approved adaptive designs that allow for study modifications based on data collected during the trial, for much greater efficiency.
Using adaptive design techniques like seamless combined-phase studies, with adaptive operations, Health Decisions will cut 25-40% off your development cycle.
Adaptive Design techniques include:
Sample-size reestimation—Sample-size reestimation uses an interim analysis of data to adjust sample size and deliver statistically significant results without waste.
Dose pruning - Many phase III studies fail because previous dose-selection studies didn’t test enough options to accurately identify the optimal dose. Adaptive dose-pruning tests more doses to find the optimal dose without breaking the budget.
Seamless combined-phase studies - Combined-phase studies roll directly from one phase into the next, eliminating between-study gaps to reduce both timelines and costs.
Early termination: failing studies faster to conserve sponsor funds - Adaptive techniques can provide for early termination for futility, preventing wasteful spending and needless patient exposure to experimental treatments.
Adaptive Operations >