Home Alzheimer’s Disease Simple Modifications of Phase I Trial Designs Could Reduce Time Required for...

Simple Modifications of Phase I Trial Designs Could Reduce Time Required for New Advances

Phase I queue (IQ) designs were associated with reduced expected study durations compared to their parent designs without changing the risk limits or maximum tolerated dose selection operating characteristics, according to a recent study published in JAMA Network Open.

There were also minimal changes in the number of patients treated and the determination of the maximum tolerated dose in this study’s modified designs, without altering operating characteristics or exceeding the parent design’s risk limits.

“We observed in our phase I studies that these details can dramatically affect phase 1 study duration and such imperfections are present in every study,” wrote the researchers. “We can adapt designs to these imperfections to reduce the study duration while not exceeding the risk permitted in the parent design or affecting the operating characteristics.”

Overall, the…

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