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Consistency of trial reporting between ClinicalTrials.gov and corresponding publications: one decade after FDAAA

(2020) Ramtin Talebi et al.   Trials

Understanding current practice, identifying barriers and exploring priorities for adverse event analysis in randomised controlled trials: an online, cross-sectional survey of statisticians from academia and industry

(2020) Rachel Phillips et al.   BMJ Open

Postmarketing commitments for novel drugs and biologics approved by the US Food and Drug Administration: a cross-sectional analysis

(2019) Joshua D. Wallach et al.   BMC Medicine

Association Between Data Sources and US Food and Drug Administration Drug Safety Communications

(2019) Noam Tau et al.   JAMA Internal Medicine

10-Year Update on Study Results Submitted to ClinicalTrials.gov

(2019) Deborah A. Zarin et al.   NEW ENGLAND JOURNAL OF MEDICINE

Noncompletion and nonpublication of trials studying rare diseases: A cross-sectional analysis

(2019) Chris A. Rees et al.   PLOS MEDICINE

The Culture of Trial Results Reporting at Academic Medical Centers

(2019) Deborah A. Zarin   JAMA Internal Medicine

Comparison of Data on Serious Adverse Events and Mortality in ClinicalTrials.gov, Corresponding Journal Articles, and FDA Medical Reviews: Cross-Sectional Analysis

(2018) Richeek Pradhan et al.   DRUG SAFETY

Postmarket Safety Events Among Novel Therapeutics Approved by the US Food and Drug Administration Between 2001 and 2010

(2017) Nicholas S. Downing et al.   JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION

Update on Trial Registration 11 Years after the ICMJE Policy Was Established

(2017) Deborah A. Zarin et al.   NEW ENGLAND JOURNAL OF MEDICINE

ClinicalTrials.gov and Drugs@FDA: A Comparison of Results Reporting for New Drug Approval Trials

(2016) Lisa M. Schwartz et al.   ANNALS OF INTERNAL MEDICINE

Trial Reporting in ClinicalTrials.gov — The Final Rule

(2016) Deborah A. Zarin et al.   NEW ENGLAND JOURNAL OF MEDICINE

Comparison of serious adverse events posted at ClinicalTrials.gov and published in corresponding journal articles

(2015) Eve Tang et al.   BMC Medicine

Compliance with Results Reporting at ClinicalTrials.gov

(2015) Monique L. Anderson et al.   NEW ENGLAND JOURNAL OF MEDICINE

Reporting Discrepancies Between the ClinicalTrials.gov Results Database and Peer-Reviewed Publications

(2014) Daniel M. Hartung et al.   ANNALS OF INTERNAL MEDICINE

Large-scale combining signals from both biomedical literature and the FDA Adverse Event Reporting System (FAERS) to improve post-marketing drug safety signal detection

(2014) Rong Xu et al.   BMC BIOINFORMATICS

Era Of Faster FDA Drug Approval Has Also Seen Increased Black-Box Warnings And Market Withdrawals

(2014) Cassie Frank et al.   HEALTH AFFAIRS

Reporting of Results in ClinicalTrials.gov and High-Impact Journals

(2014) Jessica E. Becker et al.   JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION

Non-publication and delayed publication of randomized trials on vaccines: survey

(2014) L. Manzoli et al.   BMJ-British Medical Journal

The Future of Population-Based Postmarket Drug Risk Assessment: A Regulator’s Perspective

(2013) T A Hammad et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Performance of Pharmacovigilance Signal-Detection Algorithms for the FDA Adverse Event Reporting System

(2013) R Harpaz et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

The Practice of Pre-Marketing Safety Assessment in Drug Development

(2013) Christy Chuang-Stein et al.   Journal of Biopharmaceutical Statistics

Haphazard reporting of deaths in clinical trials: a review of cases of ClinicalTrials.gov records and matched publications–a cross-sectional study

(2013) Amy Earley et al.   BMJ Open

Timing and Completeness of Trial Results Posted at ClinicalTrials.gov and Published in Journals

(2013) Carolina Riveros et al.   PLOS MEDICINE

A Lifecycle Approach to the Evaluation of FDA Approval Methods and Regulatory Actions

(2012) Bruce M. Psaty et al.   JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION

The EU-ADR Web Platform: delivering advanced pharmacovigilance tools

(2012) José Luis Oliveira et al.   PHARMACOEPIDEMIOLOGY AND DRUG SAFETY

The rise and fall of rosiglitazone

(2010) S. E. Nissen   EUROPEAN HEART JOURNAL

Reporting of Safety Results in Published Reports of Randomized Controlled Trials

(2009)   ARCHIVES OF INTERNAL MEDICINE

The New Sentinel Network — Improving the Evidence of Medical-Product Safety

(2009) Richard Platt et al.   NEW ENGLAND JOURNAL OF MEDICINE

Trial Publication after Registration in ClinicalTrials.Gov: A Cross-Sectional Analysis

(2009) Joseph S. Ross et al.   PLOS MEDICINE

Systematic Review of the Empirical Evidence of Study Publication Bias and Outcome Reporting Bias

(2008) Kerry Dwan et al.   PLoS One