The late stage failure of drug development programs is a significant problem. Successful phase 2 trial results do not guarantee a successful phase 3 program. The estimated probability of progressing from phase 3 analgesic clinical trials to regulatory approval is approximately 57%, suggesting that a considerable number of treatments with phase 2 trial results deemed sufficiently successful to progress to phase 3 do not yield positive phase 3 results.33 Potential explanations for this high rate of failure in late stage development include (1) false positive phase 2 trial results, (2) incorrect dosage selection based on phase 2 trial data, (3) phase 2 and 3 clinical trial design features that compromise assay sensitivity (i.e., the ability of a trial to detect a true treatment effect); for example, entry criteria that are too heterogeneous or inappropriate outcome measures, (4) insufficient increase in sample size between phase 2 and 3 to accommodate potential increased heterogeneity in the target population in larger, phase 3 trials, and (5) low quality execution of the phase 2 or phase 3 trial.
from The Journal of Pain https://ift.tt/2qOSEXA
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