Improving study conduct and data quality in clinical trials of chronic pain treatments: IMMPACT recommendations
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 suffici ently 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 tri al 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 inc reased heterogeneity in the target population in larger, phase 3 trials, and (5) low quality execution of the phase 2 or phase 3 trial.
Source: The Journal of Pain - Category: Materials Science Authors: Jennifer S. Gewandter, Robert H. Dworkin, Dennis C. Turk, Eric G. Devine, David Hewitt, Mark P. Jensen, Nathaniel P. Katz, Amy A. Kirkwood, Richard Malamut, John D. Markman, Bernard Vrijens, Laurie Burke, James N. Campbell, Daniel B. Carr, Philip G. Conag Source Type: research