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(262) Reporting of primary analyses and multiplicity adjustment in recent analgesic clinical trials: ACTTION systematic review and recommendations

2014; Elsevier BV; Volume: 15; Issue: 4 Linguagem: Inglês

10.1016/j.jpain.2014.01.170

1528-8447

Jennifer S. Gewandter, Shannon M. Smith, Andrew McKeown, Laurie B. Burke, Sharon Hertz, Matthew Hunsinger, Nathaniel P. Katz, Allison H. Lin, Michael McDermott, Bob A. Rappaport, M. Williams, D. Turk, Robert H. Dworkin,

Health Systems, Economic Evaluations, Quality of Life

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 pre-specification 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 three major pain journals (i.e., European Journal of Pain, Journal of Pain, Pain). A total of 160 randomized controlled trials investigating non-invasive pharmacological treatments or interventional treatments for pain, published between 2006 and 2012, were included. Only 53% of trials identified a primary analysis and only 10% of trials reported pre-specification 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 pre-specification 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 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. Financial support for this project was provided by the ACTTION public-private partnership which has received research contracts, grants, or other revenue from the FDA, Astellas, Bristol-Myers Squibb, Collegium, Depomed, Eli Lilly, Horizon, Jazz, Johnson & Johnson, Mallinckrodt, Pfizer, Purdue, Zalicus, and other sources.