doi: 10.1371/journal.pctr.0020018.
When and how can endpoints be changed after initiation of a randomized clinical trial?
Affiliations
- PMID: 17443237
- PMCID: PMC1852589
- DOI: 10.1371/journal.pctr.0020018
Item in Clipboard
When and how can endpoints be changed after initiation of a randomized clinical trial?
PLoS Clin Trials.
.
No abstract available
Conflict of interest statement
Similar articles
-
Discrepancies in endpoints between clinical trial protocols and clinical trial registration in randomized trials in oncology.BMC Med Res Methodol. 2018 Dec 12;18(1):169. doi: 10.1186/s12874-018-0627-2. BMC Med Res Methodol. 2018. PMID: 30541475 Free PMC article.
-
The Future of Clinical Trial Design: The Transition from Hard Endpoints to Value-Based Endpoints.Handb Exp Pharmacol. 2019;260:371-397. doi: 10.1007/164_2019_302. Handb Exp Pharmacol. 2019. PMID: 31707472 Review.
-
Rationalizing endpoints for prospective studies of pulmonary exacerbation treatment response in cystic fibrosis.J Cyst Fibros. 2017 Sep;16(5):607-615. doi: 10.1016/j.jcf.2017.04.004. Epub 2017 Apr 21. J Cyst Fibros. 2017. PMID: 28438499 Free PMC article.
-
Impact of weighted composite compared to traditional composite endpoints for the design of randomized controlled trials.Stat Methods Med Res. 2015 Dec;24(6):980-8. doi: 10.1177/0962280211436004. Epub 2012 Jan 24. Stat Methods Med Res. 2015. PMID: 22275378
-
Endpoints for tricuspid regurgitation trans-catheter therapy trials.Prog Cardiovasc Dis. 2019 Nov-Dec;62(6):479-481. doi: 10.1016/j.pcad.2019.11.019. Epub 2019 Dec 2. Prog Cardiovasc Dis. 2019. PMID: 31805295 Review.
Cited by
-
Recent innovations in adaptive trial designs: A review of design opportunities in translational research.J Clin Transl Sci. 2023 Apr 28;7(1):e125. doi: 10.1017/cts.2023.537. eCollection 2023. J Clin Transl Sci. 2023. PMID: 37313381 Free PMC article. Review.
-
Inside the Mind of the DMC: A Review of Principles and Issues with Case Studies.Ther Innov Regul Sci. 2025 Mar;59(2):234-244. doi: 10.1007/s43441-024-00720-8. Epub 2024 Dec 17. Ther Innov Regul Sci. 2025. PMID: 39688768 Review.
-
Impact of the COVID-19 pandemic on statistical design and analysis plans for multidomain intervention clinical trials: Experience from World-Wide FINGERS.Alzheimers Dement (N Y). 2021 Mar 11;7(1):e12143. doi: 10.1002/trc2.12143. eCollection 2021. Alzheimers Dement (N Y). 2021. PMID: 33738333 Free PMC article.
-
Essential statistical principles of clinical trials of pain treatments.Pain Rep. 2020 Dec 18;6(1):e863. doi: 10.1097/PR9.0000000000000863. eCollection 2021 Jan-Feb. Pain Rep. 2020. PMID: 33521483 Free PMC article. Review.
-
An empirical assessment of research practices across 163 clinical trials of tumor-bearing companion dogs.Sci Rep. 2019 Aug 15;9(1):11877. doi: 10.1038/s41598-019-48425-5. Sci Rep. 2019. PMID: 31417164 Free PMC article.
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.
LinkOut - more resources
Full Text Sources
