@article{e09d110255f74a59a3f976597ebe74bc,
title = "Harms are assessed inconsistently and reported inadequately Part 2: nonsystematic adverse events",
abstract = "Objective: We examined nonsystematic adverse events (AEs) in Part 2 (of 2) of a study describing the assessment and reporting AEs in clinical trials. Study Design and Setting: We examined 21 trials of gabapentin for neuropathic pain (52 sources) and seven trials of quetiapine for bipolar depression (80 sources) using data from the Multiple Data Sources study. We extracted and compared information about nonsystematic AEs (i.e., AEs that were not assessed for every participant), including AEs categorized as “serious.” We recorded whether AEs were grouped by anatomic or physiological system. Results: Trials of the same drug reported information about different AEs. Information in public sources was inadequate for decision-making. No public source reported all AEs, or all serious AEs, identified in nonpublic sources about the same trial. Of trials with only public sources, 2/15 (13%) gabapentin and 0/3 (0%) quetiapine trials grouped AEs by anatomic or physiological system. Conclusion: Public sources contained little information about nonsystematic AEs, including serious AEs. Grouping might make nonsystematic AEs easier to detect; however, most public sources did not report grouped AEs. Standards are needed to improve the collection and reporting of nonsystematic AEs so that stakeholders can use trials to assess the balance of potential benefits and harms.",
keywords = "Adverse events, Clinical trials, Drug safety, Harms, Open science, Reporting bias",
author = "{MUDS investigators} and Mayo-Wilson, {Evan R} and Nicole Fusco and Tianjing Li and Hwanhee Hong and Canner, {Joseph K.} and Kay Dickersin and Lorenzo Bertizzolo and Terrie Cowley and Peter Doshi and Jeffrey Ehmsen and Gillian Gresham and Nan Guo and Jennifer Haythornthwaite and James Heyward and Diana Pham and Jennifer Payne and Lori Rosman and Elizabeth Stuart and Catalina Suarez-Cuervo and Elizabeth Tolbert and Claire Twose and Swaroop Vedula",
note = "Funding Information: Funding: This study was supported by contract ME 1303 5785 from the Patient Centered Outcomes Research Institute (PCORI) and funds established for scholarly research on reporting biases at Johns Hopkins University by Greene LLP. The funders were not involved in the design or conduct of the study, article preparation, or the decision to submit the article for publication. Funding Information: For the collaborators: Terrie Cowley is President of The TMJ Association, Ltd., which received funding from Pfizer from 2009 to 2011 (for the Campaign to End Chronic Pain in Women) and from Purdue Pharma, L.P. in 2008, 2010, and 2012 to 2016 (to support the TMJ Association science meeting and develop educational materials based on scientific research advances). Peter Doshi was a corecipient of a UK National Institute for Health Research grant (HTA – 10/80/01 Update and amalgamation of two Cochrane reviews: neuraminidase inhibitors for preventing and treating influenza in healthy adults and children— http://www.nets.nihr.ac.uk/projects/hta/108001 ). Peter Doshi received €1,500 from the European Respiratory Society in support of his travel to the society's September 2012 annual congress in Vienna, where he gave an invited talk on oseltamivir. Peter Doshi gratefully acknowledges the American Association of Colleges of Pharmacy for its funding support ($11,000) for a study to analyze written medical information regarding the possible harms of statins. AACP had no involvement in the design and conduct of the study; collection, management, analysis, and interpretation of the data; and preparation, review, or approval of this article. Peter Doshi is also an associate editor of The BMJ and an unpaid member of the IMEDS steering committee at the Reagan-Udall Foundation for the FDA, which focuses on drug safety research. Publisher Copyright: {\textcopyright} 2019 The Authors",
year = "2019",
month = sep,
doi = "10.1016/j.jclinepi.2019.04.020",
language = "English (US)",
volume = "113",
pages = "11--19",
journal = "Journal of Clinical Epidemiology",
issn = "0895-4356",
publisher = "Elsevier USA",
}