Completeness of Safety Reporting in Randomized Trials

John P. A. Ioannidis, Joseph Lau

Type: Article

Publication Date: 2001-01-24

Citations: 539

DOI: https://doi.org/10.1001/jama.285.4.437

View Publication

Locations

JAMA - View
PubMed - View

Similar Works

Action	Title	Year	Authors
+ PDF Chat	Drug safety assessment in clinical trials: methodological challenges and opportunities	2012	Sonal Singh Yoon K. Loke
+	Reporting of meta-analyses of randomized controlled trials with a focus on drug safety: An empirical assessment	2013	Tarek A. Hammad George A. Neyarapally Simone P. Pinheiro Solomon Iyasu G. D. Rochester Gerald J. Dal Pan
+	Reporting of clinical trial safety results in ClinicalTrials.gov for FDA-approved drugs: A cross-sectional analysis	2022	Krista Y. Chen Erin Borglund Emma Charlotte Postema Adam G. Dunn Florence T. Bourgeois
+	Secondary use of randomized controlled trials to evaluate drug safety: a review of methodological considerations	2011	Tarek A. Hammad Simone P. Pinheiro George A. Neyarapally
+ PDF Chat	Analysis and reporting of adverse events in randomised controlled trials: a review	2019	Rachel Phillips Lorna Hazell Odile Sauzet Victoria Cornelius
+ PDF Chat	Determining the reporting quality of RCTs in clinical pharmacology	2004	Edward J. Mills Yoon K. Loke Ping Wu Víctor M. Montori Daniel Perri David Moher Gordon Guyatt
+	Pitfalls in meta‐analyses on adverse events reported from clinical trials	2011	Hanyao Huang Elizabeth Andrews Judith K. Jones Mary Lou Skovron Hugh A. Tilson
+	An audit of safety reporting in randomized controlled trials over a five-year period in a high impact factor journal	2021	Mahanjit Konwar Ambika Mamde Panini Patankar Urmila Thatte Nitin Gogtay
+	Reporting adverse events in randomized controlled trials	2006	Jim Nuovo Curtis Sather
+ PDF Chat	Reporting Discrepancies Between the ClinicalTrials.gov Results Database and Peer-Reviewed Publications	2014	Daniel M. Hartung Deborah A. Zarin Jeanne‐Marie Guise Marian McDonagh Robin Paynter Mark Helfand
+	Lack of detail and uniformity in the reporting of adverse drug reactions in randomized controlled trials: important implications for systematic reviews	2001	Yoon K. Loke Sheena Derry
+	Reporting of Safety Results in Published Reports of Randomized Controlled Trials	2009	Isabelle Pitrou Isabelle Boutron Nizar Ahmad Philippe Ravaud
+	Adverse events reported in randomized clinical trials of drug therapies: the information is still insufficient	2013	Cátia Bauer Maggi Isabel Heinzmann Griebeler Tatiane da Silva Dal Pizzol
+ PDF Chat	When Can Nonrandomized Studies Support Valid Inference Regarding Effectiveness or Safety of New Medical Treatments?	2021	Jessica M. Franklin Richard Platt Nancy A Dreyer Alex John London Gregory E. Simon Jonathan H. Watanabe Michael A. Horberg Adrian F. Hernandez Robert M. Califf
+ PDF Chat	A new risk of bias checklist applicable to randomized trials, observational studies, and systematic reviews was developed and validated to be used for systematic reviews focusing on drug adverse events	2017	Jean‐Luc Faillie Pili Ferrer Amandine Gouverneur Damien Driot Shoma Berkemeyer Xavier Vidal Maria José Martínez‐Zapata Consuelo Huerta Xavier Castells Marietta Rottenkolber
+ PDF Chat	Adverse Event Reporting in Cancer Clinical Trial Publications	2013	Shanthi Sivendran Asma Latif Russell B. McBride Kristian Stensland Juan P. Wisnivesky Lindsay Haines William Oh Matthew D. Galsky
+	Randomized Controlled Trials and Assessment of Drug Safety	2008	David W. J. Clark David M Coulter Frank Besag
+	Randomized Controlled Trials and Assessment of Drug Safety	2008	David W. J. Clark David M Coulter Frank Besag
+	The reporting of harms in publications on randomized controlled trials funded by the “Programme Hospitalier de Recherche Clinique,” a French academic funding scheme	2018	Romain Favier Sabrina Crépin
+ PDF Chat	PMU39 APPROACHES TO SAFETY REPORTING IN OBSERVATIONAL STUDIES	2019	Christy Guyan K. Wong

Works That Cite This (91)

Action	Title	Year	Authors
+	Clinical trials, immunosuppression and renal transplantation: new trends in design and analysis	2002	Paul Landais Jean‐Pierre Daurès
+	Strategies for Safety Reporting in Substance Abuse Trials	2011	Robert Lindblad Maria Campanella David Styers Prasad Kothari Steve Sparenborg Carmen La Rosa
+ PDF Chat	Comparison of Treatment Effect Estimates for Pharmacological Randomized Controlled Trials Enrolling Older Adults Only and Those including Adults: A Meta-Epidemiological Study	2013	Valérie Seegers Ludovic Trinquart Isabelle Boutron Philippe Ravaud
+	Challenges in Systematic Reviews That Assess Treatment Harms	2005	Roger Chou Mark Helfand
+ PDF Chat	A Field Test of Major Value Frameworks in Chemotherapy of Nasopharyngeal Carcinoma—To Know, Then to Measure	2020	Yuan Zhang Xu Liu Ying‐Qin Li Ling‐Long Tang Lei Chen Jun Ma
+ PDF Chat	How Good Is “Evidence” from Clinical Studies of Drug Effects and Why Might Such Evidence Fail in the Prediction of the Clinical Utility of Drugs?	2014	Huseyin Naci John P. A. Ioannidis
+ PDF Chat	Reporting quality of abstracts in phase III clinical trials of systemic therapy in metastatic solid malignancies	2015	Shanthi Sivendran Kristina Newport Michael Horst Adam Albert Matthew D. Galsky
+ PDF Chat	Quality of adverse event reporting in phase III randomized controlled trials of breast and colorectal cancer: A systematic review	2020	Adam S. Komorowski Helen Mackay Rossanna C. Pezo
+	Secondary use of randomized controlled trials to evaluate drug safety: a review of methodological considerations	2011	Tarek A. Hammad Simone P. Pinheiro George A. Neyarapally
+	Evaluation of the patient experience of symptomatic adverse events on Phase I clinical trials using PRO-CTCAE	2022	Geoffrey Alan Watson Zachary Veitch Daniel Shepshelovich Zhihui Amy Liu Anna Spreafico Albiruni R. Abdul Razak Philippe L. Bédard Lillian L. Siu Lori M. Minasian Aaron R. Hansen

Works Cited by This (6)

Action	Title	Year	Authors
+ PDF Chat	Identification of adverse reactions to new drugs. II (continued): How were 18 important adverse reactions discovered and with what delays?	1983	G R Venning
+	Statistical Problems in the Reporting of Clinical Trials	1987	Stuart J. Pocock Michael D. Hughes Robert J. Lee
+	Cumulative meta-analysis of clinical trials builds evidence for exemplary medical care	1995	Joseph Lau Christopher H. Schmid Thomas C. Chalmers
+	Introducing MEDWatch. A new approach to reporting medication and device adverse effects and product problems	1993	David A. Kessler
+	Confidence intervals for a binomial proportion	1993	Dan J. Stein
+ PDF Chat	Cumulative Meta-Analysis of Therapeutic Trials for Myocardial Infarction	1992	Joseph Lau Elliott M. Antman Jeanette Jimenez-Silva Bruce Kupelnick Frederick Mosteller Thomas C. Chalmers