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| Content Provider | World Health Organization (WHO)-Global Index Medicus |
|---|---|
| Author | Gøtzsche, Peter C. Tendal, Britta Maund, Emma Hróbjartsson, Asbjørn Jørgensen, Karsten Juhl Lundh, Andreas Schroll, Jeppe |
| Description | Author Affiliation: Maund E ( Nordic Cochrane Centre, Rigshospitalet Dept 7811, Copenhagen, Denmark em@cochrane.dk.); Tendal B ( Nordic Cochrane Centre, Rigshospitalet Dept 7811, Copenhagen, Denmark.); Hróbjartsson A ( Nordic Cochrane Centre, Rigshospitalet Dept 7811, Copenhagen, Denmark.); Jørgensen KJ ( Nordic Cochrane Centre, Rigshospitalet Dept 7811, Copenhagen, Denmark.); Lundh A ( Nordic Cochrane Centre, Rigshospitalet Dept 7811, Copenhagen, Denmark Department of Infectious Diseases, Hvidovre University Hospital, Kettegårds Allé 30, 2650 Hvidovre, Denmark.); Schroll J ( Nordic Cochrane Centre, Rigshospitalet Dept 7811, Copenhagen, Denmark.); Gøtzsche PC ( Nordic Cochrane Centre, Rigshospitalet Dept 7811, Copenhagen, Denmark.); |
| Abstract | Objective To determine, using research on duloxetine for major depressive disorder as an example, if there are inconsistencies between protocols, clinical study reports, and main publicly available sources (journal articles and trial registries), and within clinical study reports themselves, with respect to benefits and major harms. Design Data on primary efficacy analysis and major harms extracted from each data source and compared. Setting Nine randomised placebo controlled trials of duloxetine (total 2878 patients) submitted to the European Medicines Agency (EMA) for marketing approval for major depressive disorder. Data sources Clinical study reports, including protocols as appendices (total 13 729 pages), were obtained from the EMA in May 2011. Journal articles were identified through relevant literature databases and contacting the manufacturer, Eli Lilly. Clinicaltrials.gov and the manufacturer’s online clinical trial registry were searched for trial results. Results Clinical study reports fully described the primary efficacy analysis and major harms (deaths (including suicides), suicide attempts, serious adverse events, and discontinuations because of adverse events). There were minor inconsistencies in the population in the primary efficacy analysis between the protocol and clinical study report and within the clinical study report for one trial. Furthermore, we found contradictory information within the reports for seven serious adverse events and eight adverse events that led to discontinuation but with no apparent bias. In each trial, a median of 406 (range 177-645) and 166 (100-241) treatment emergent adverse events (adverse events that emerged or worsened after study drug was started) in the randomised phase were not reported in journal articles and Lilly trial registry reports, respectively. We also found publication bias in relation to beneficial effects. Conclusion Clinical study reports contained extensive data on major harms that were unavailable in journal articles and in trial registry reports. There were inconsistencies between protocols and clinical study reports and within clinical study reports. Clinical study reports should be used as the data source for systematic reviews of drugs, but they should first be checked against protocols and within themselves for accuracy and consistency. |
| ISSN | 09598138 |
| e-ISSN | 17561833 |
| Journal | BMJ (British Medical Journal) |
| Volume Number | 348 |
| Language | English |
| Publisher | British Medical Journal Publishing Group |
| Publisher Date | 2014-06-01 |
| Publisher Place | Great Britain (UK) |
| Access Restriction | Open |
| Subject Keyword | Adrenergic Uptake Inhibitors Therapeutic Use Antidepressive Agents Clinical Trials As Topic Depressive Disorder, Major Drug Therapy Serotonin Uptake Inhibitors Thiophenes Adverse Effects Clinical Protocols Duloxetine Hydrochloride Registries Research Support, Non-U.S. Gov't Medicine |
| Content Type | Text |
| Resource Type | Article |
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