March 1, 2013: Two SABRRE Working Group Articles on Adverse Event Reporting Appearing in Pain
The following two articles, prepared by the ACTTION Safety and Benefit-Risk Reporting and Evaluation (SABRRE) Working Group, have recently been published and accepted for publication in Pain. The articles describe analyses of safety reporting in recent analgesic clinical trials and present a checklist to assist investigators in thoroughly and consistently capturing and reporting the adverse event data necessary to determine a treatment's risk-benefit profile.
Smith SM, Chang RD, Pereira A, Shah N, Gilron I, Katz NP, Lin AH, McDermott MP, Rappaport BA, Rowbotham MC, Sampaio C, Turk DC, Dworkin RH. Adherence to CONSORT harms reporting recommendations in publications of recent analgesic clinical trials: an ACTTION systematic review. Pain, 2012;153:2415-2421.
Smith SM, Wang AT, Katz NP, McDermott MP, Burke LB, Coplan P, Gilron I, Hertz SH, Lin AH, Rappaport BA, Rowbotham MC, Sampaio C, Sweeney M, Turk DC, Dworkin RH. Adverse event assessment, analysis, and reporting in recent published analgesic clinical trials: ACTTION review and recommendations. Pain, in press.