Adaptive trials show risk, gain

Finally, some detail on the far-more-hyped-than-tried adaptive clinical trial. Two trials show that adaptive techniques have their place.

The two are different in phase, size, geographic reach, and adaptive technique: One involves a pharma giant's oncology drug candidate trial, which employed the adaptive technique of sample size re-estimation. The company says the technique resulted in a market presence a year ahead of schedule, yielding a $366-million sales increase.

The other is a large, complex device trial for a small biotech. This trial showed that adaptive techniques can introduce risk and compromise data integrity. But by applying adaptive methodologies intended for design changes to trial enrollment, data management, and monitoring functions, the sponsor achieved "substantial savings."

Both trials will be described in a free webinar this Wednesday by Health Decisions and the Center for Business Intelligence.

- here's the announcement

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