| The interpretation of clinical trial data--wrongly ACCLAIM'ed? | |
| | |
MedLine Citation:
|
PMID: 19619687 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
|
Advances in medicine continue to drive forward through the practice of often impressive and innovative investigation. Through the application of randomized clinical trials, statistical analyses deliver the notorious "P values" to provide evidence of whether an intervention results in the desired clinical effect. However, it would appear that it is becoming increasingly common for trial reports to "cheat" the statistical system, particularly when lucrative industrial reward might be at stake. Fortunately, there is a safety net in place for the clinician who is less well accustomed to critiquing the research manuscript. In the United States, the Food and Drug Administration rigorously analyzes evidence relating to safety and efficacy of new therapies before approving them for general use. In Europe, the European Medicines Agency provides a similar service. Yet of much concern, there appears to be clear differences over the respective level of scrutiny of clinical trial data. This article discusses the unease of how a flawed international trial report appeared to deceive the European Union into approving a device-based product for chronic heart failure despite an important lack of credible data. |
| | |
Authors:
|
Steven M Shaw; Nizar Yonan; Simon G Williams; James E Fildes |
Related Documents
:
|
21631757 - Maintaining oral hydration in older adults living in residential aged care facilities. 21616017 - Better knowledge, better health: piloting an education intervention in chronic conditio... 21925807 - Identifying provider beliefs related to contingency management adoption using the conti... 21848727 - The challenges of managing complex lymphoedema/chronic oedema in the uk and canada. 16570377 - An evaluation of the role of risk-based decision-making in a former manufactured gas pl... 17447677 - Use some horse sense with qc. |
Publication Detail:
|
Type: Editorial |
Journal Detail:
|
Title: American heart journal Volume: 158 ISSN: 1097-6744 ISO Abbreviation: Am. Heart J. Publication Date: 2009 Aug |
Date Detail:
|
Created Date: 2009-07-21 Completed Date: 2009-08-21 Revised Date: - |
Medline Journal Info:
|
Nlm Unique ID: 0370465 Medline TA: Am Heart J Country: United States |
Other Details:
|
Languages: eng Pagination: 149-51 Citation Subset: AIM; IM |
Export Citation:
|
APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
|
Device Approval* Endpoint Determination Europe Heart Failure / immunology, therapy* Humans Randomized Controlled Trials as Topic* Research Design United States United States Food and Drug Administration |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
Previous Document: The elimination of the onchocerciasis vector from the island of Bioko as a result of larviciding by ...
Next Document: Atherosclerotic renal artery stenosis: current therapy and future developments.