Scientific Publications by FDA Staff
Pain 2014 Mar;155(3):461-6
Reporting of primary analyses and multiplicity adjustment in recent analgesic clinical trials: ACTTION systematic review and recommendations.
Gewandter JS, Smith SM, McKeown A, Burke LB, Hertz SH, Hunsinger M, Katz NP, Lin AH, McDermott MP, Rappaport BA, Williams MR, Turk DC, Dworkin RH
Performing multiple analyses in clinical trials can inflate the probability of a type I error, or the chance of falsely concluding a significant effect of the treatment. Strategies to minimize type I error probability include prespecification of primary analyses and statistical adjustment for multiple comparisons, when applicable. The objective of this study was to assess the quality of primary analysis reporting and frequency of multiplicity adjustment in 3 major pain journals (ie, European Journal of Pain, Journal of Pain, and PAIN(R)). A total of 161 randomized controlled trials investigating noninvasive pharmacological treatments or interventional treatments for pain, published between 2006 and 2012, were included. Only 52% of trials identified a primary analysis, and only 10% of trials reported prespecification of that analysis. Among the 33 articles that identified a primary analysis with multiple testing, 15 (45%) adjusted for multiplicity; of those 15, only 2 (13%) reported prespecification of the adjustment methodology. Trials in clinical pain conditions and industry-sponsored trials identified a primary analysis more often than trials in experimental pain models and non-industry-sponsored trials, respectively. The results of this systematic review demonstrate deficiencies in the reporting and possibly the execution of primary analyses in published analgesic trials. These deficiencies can be rectified by changes in, or better enforcement of, journal policies pertaining to requirements for the reporting of analyses of clinical trial data.
|Category: Journal Article, Review|
|PubMed ID: #24275257||DOI: 10.1016/j.pain.2013.11.009|
|Includes FDA Authors from Scientific Area(s): Drugs|
|Entry Created: 2014-04-09||Entry Last Modified: 2014-05-10|