Reporting of Drug Tolerance in Randomized Clinical Trials: When Data Conflict with Authors' Conclusions
Authors: Annie Pierre Jonville-Béra, Bruno Giraudeau, Elisabeth Autret-Leca
Journal: Annals of Internal Medicine (2006)

Letters21 February 2006Reporting of Drug Tolerance in Randomized Clinical Trials: When Data Conflict with Authors' ConclusionsAnnie Pierre Jonville-Béra, MD, Bruno Giraudeau, PhD, and Elisabeth Autret-Leca, MDAnnie Pierre Jonville-Béra, MDFrom University Hospital of Tours, 37044 Tours, France., Bruno Giraudeau, PhDFrom University Hospital of Tours, 37044 Tours, France., and Elisabeth Autret-Leca, MDFrom University Hospital of Tours, 37044 Tours, France.Author, Article, and Disclosure Informationhttps://doi.org/10.7326/0003-4819-144-4-200602210-00024 SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail TO THE EDITOR:Background: Double-blind randomized trials that compare the efficacy of a new drug with an older drug or with placebo also often provide information regarding safety. When these findings are published, some authors conclude that the new drug has a "good safety profile" just because they failed to find any statistical difference in frequencies of adverse effects.Objective: The goal of this study is to illustrate this misreporting of data and to propose parameters that would promote more objective reports of safety results.Methods: We selected 2 published clinical trials (1, 2) that compared pharmacologic treatments for which ...References1. Lassen MR, Bauer KA, Eriksson BI, Turpie AG. Postoperative fondaparinux versus preoperative enoxaparin for prevention of venous thromboembolism in elective hip-replacement surgery: a randomised double-blind comparison. Lancet. 2002;359:1715-20. [PMID: 12049858] CrossrefMedlineGoogle Scholar2. de Gans J, van de Beek D. Dexamethasone in adults with bacterial meningitis. N Engl J Med. 2002;347:1549-56. [PMID: 12432041] CrossrefMedlineGoogle Scholar3. Bounameaux H, Perneger T. Fondaparinux: a new synthetic pentasaccharide for thrombosis prevention. Lancet. 2002;359:1710-1. [PMID: 12049854] CrossrefMedlineGoogle Scholar4. Katz D, Baptista J, Azen SP, Pike MC. Obtaining confidence intervals for the risk ratio in cohort studies. Biometrics. 1978;34:469-474. CrossrefGoogle Scholar5. Newcombe RG. Interval estimation for the difference between independent proportions: comparison of eleven methods. Stat Med. 1998;17:873-90. [PMID: 9595617] CrossrefMedlineGoogle Scholar6. Goodman SN, Berlin JA. The use of predicted confidence intervals when planning experiments and the misuse of power when interpreting results. Ann Intern Med. 1994;121:200-6. [PMID: 8017747] LinkGoogle Scholar7. Altman DG, Bland JM. Absence of evidence is not evidence of absence. BMJ. 1995;311:485. [PMID: 7647644] CrossrefMedlineGoogle Scholar Author, Article, and Disclosure InformationAffiliations: From University Hospital of Tours, 37044 Tours, France.Disclosures: None disclosed. PreviousarticleNextarticle Advertisement FiguresReferencesRelatedDetailsSee AlsoThe Use of Predicted Confidence Intervals When Planning Experiments and the Misuse of Power When Interpreting Results Steven N. Goodman and Jesse A. Berlin Brief Communication: Better Ways To Question Patients about Adverse Medical Events Stephen Bent , Amy Padula , and Andrew L. Avins Adverse Events: The More You Search, the More You Find John P.A. Ioannidis , Cynthia D. Mulrow , and Steven N. Goodman Metrics Cited BySuicidality and other severe psychiatric events with duloxetine: Re-analysis of safety data from a placebo-controlled trial for juvenile fibromyalgiaInferences About Drug Safety in Phase III Trials in Oncology: Examples From Advanced Prostate CancerInterpretation of chronic pain clinical trial outcomes: IMMPACT recommended considerationsIntroductionConclusionAdverse Effects of Psychotropic MedicationsAdverse event assessment, analysis, and reporting in recent published analgesic clinical trials: ACTTION systematic review and recommendationsEmbellissement des données : fraude a minima, incompétence ou un mélange des deuxMisleading abstract conclusions in randomized controlled trials in rheumatology: Comparison of the abstract conclusions and the results sectionConclusions erronées des résumés dans les essais cliniques contrôlés en rhumatologie : comparaisons entre les conclusions et la partie résultats des résumésAHRQ Series Paper 4: Assessing harms when comparing medical interventions: AHRQ and the Effective Health-Care ProgramAntipyretic drug use in children in French office based medical practiceAdverse Events: The More You Search, the More You FindJohn P.A. Ioannidis, MD, Cynthia D. Mulrow, MD, MSc, Deputy Editor, and Steven N. Goodman, MD, PhD 21 February 2006Volume 144, Issue 4Page: 306-307KeywordsAdverse eventsConflicts of interestDrug safetyDrugsHemorrhageSafetySafety studies ePublished: 21 February 2006 Issue Published: 21 February 2006 CopyrightCopyright © 2006 by American College of Physicians. All Rights Reserved.PDF DownloadLoading ...