When and how can endpoints be changed after initiation of a randomized clinical trial?
- PMID: 17443237
- PMCID: PMC1852589
- DOI: 10.1371/journal.pctr.0020018
When and how can endpoints be changed after initiation of a randomized clinical trial?
Conflict of interest statement
References
-
- The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH harmonized tripartite guideline: Statistical principles for clinical trials, E-9. 1998. Available: http://www.ich.org/LOB/media/MEDIA485.pdf. Accessed 6 March 2007.
-
- Dormandy J, Charbonnel B, Eckland D, Erdmann E, Massi-Benedetti M, et al. Secondary prevention of macrovascular events in patients with type 2 diabetes in the PROactive study (PROspective pioglitAzone Clinical Trial In macroVascular Events): A randomized controlled trial. Lancet. 2006;366:1279–1289. - PubMed
-
- Skyler JS. PROactive results overstated and misleading. DOC News. 2005;2:4.
-
- Charbonnel B, Dormandy J, Erdmann E, Massi-Benedetti M, Skene A. The prospective pioglitazone clinical trial in macrovascular events (PROactive): Can pioglitazone reduce cardiovascular events in diabetes? Study design and baseline characteristics of 5238 patients. Diabetes Care. 2004;27:1647–1653. - PubMed
-
- Dormandy J, Charbonnel B, Eckland D, Erdmann E, Massi-Benedetti M, et al. PROactive study. Lancet. 2006;367:982.
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