Controlled Clinical Trials

Clinical trials involving one or more test treatments, at least one control treatment, specified outcome measures for evaluating the studied intervention, and a bias-free method for assigning patients to the test treatment. The treatment may be drugs, devices, or procedures studied for diagnostic, therapeutic, or prophylactic effectiveness. Control measures include placebos, active medicines, no-treatment, dosage forms and regimens, historical comparisons, etc. When randomization using mathematical techniques, such as the use of a random numbers table, is employed to assign patients to test or control treatments, the trials are characterized as RANDOMIZED CONTROLLED TRIALS AS TOPIC.

Appraisal of: Wieseler B, Wolfram N, McGauran N et al. Completeness of reporting of patient-relevant clinical trial outcomes: comparison of unpublished clinical study reports with publicly available data. PLoS Med 2013;10(10):e1001526.

Reviewer(s): 
Short description: 
The authors compared the information available in clinical study reports and in publicly accessible sources (journal articles, registry reports) included in 16 HTA reports for drugs prepared in IQWiG. They assessed the completeness of information on patient-relevant benefit (e.g. symptom relief, health related quality of life) and harm (adverse effects) outcomes reported in each document type. Clinical study reports provided complete information of all outcomes on a higher proportion (86%) than publicly accessible sources (39%). They also provided more information on harms (87% versus 43 %). The authors conclude that clinical study reports should be made publicly available for the benefit of unbiased trial evaluation and informed decision-making in health care.
Limitations stated by the author(s): 
The main limitation was that the authors could only study those clinical study reports that were provided voluntarily upon request by the pharmaceutical companies. Also, the sample of clinical study reports was restricted on studies investigating drugs.
Limitations stated by the reviewer(s): 
No additional limitations detected by the reviewer.
Study Type: 
Single study
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