The gap between clinical trials and clinical practice: the use of pragmatic clinical trials to inform regulatory decision making
- PMID: 20010554
- DOI: 10.1038/clpt.2009.218
The gap between clinical trials and clinical practice: the use of pragmatic clinical trials to inform regulatory decision making
Similar articles
-
Note on special technical issue on adaptive designs for clinical trials.J Biopharm Stat. 2012;22(4):615-6. doi: 10.1080/10543406.2012.684507. J Biopharm Stat. 2012. PMID: 22651104 No abstract available.
-
Disease models.Clin Adv Hematol Oncol. 2008 Apr;6(4):241-2. Clin Adv Hematol Oncol. 2008. PMID: 18496490 No abstract available.
-
Similarity trials.Nat Biotechnol. 2011 Jan;29(1):1. doi: 10.1038/nbt.1760. Nat Biotechnol. 2011. PMID: 21221076 No abstract available.
-
Patient-reported outcomes: assessment and current perspectives of the guidelines of the Food and Drug Administration and the reflection paper of the European Medicines Agency.Eur J Cancer. 2009 Feb;45(3):347-53. doi: 10.1016/j.ejca.2008.09.032. Epub 2008 Nov 14. Eur J Cancer. 2009. PMID: 19013787 Review.
-
Effective global drug development strategy for obtaining regulatory approval in Japan in the context of ethnicity-related drug response factors.Clin Pharmacol Ther. 2010 Mar;87(3):362-6. doi: 10.1038/clpt.2009.285. Epub 2010 Jan 27. Clin Pharmacol Ther. 2010. PMID: 20107436 Review. No abstract available.
Cited by
-
Effectiveness and Safety of Statin Therapy in Children: A Real-World Clinical Practice Experience.CJC Open. 2020 Jun 6;2(6):473-482. doi: 10.1016/j.cjco.2020.06.002. eCollection 2020 Nov. CJC Open. 2020. PMID: 33305206 Free PMC article.
-
Long-term follow-up of statin treatment in a cohort of children with familial hypercholesterolemia: efficacy and tolerability.Paediatr Drugs. 2011 Aug 1;13(4):267-75. doi: 10.2165/11591650-000000000-00000. Paediatr Drugs. 2011. PMID: 21692550
-
A Detailed Analysis of the Past 20 Years of US FDA-Approved Prescription to Over-the-Counter Switches.Ther Innov Regul Sci. 2023 Sep;57(5):1074-1080. doi: 10.1007/s43441-023-00547-9. Epub 2023 Jun 25. Ther Innov Regul Sci. 2023. PMID: 37357243 Free PMC article.
-
Leveraging Genomic Data in Smoking Cessation Trials in the Era of Precision Medicine: Why and How.Nicotine Tob Res. 2018 Mar 6;20(4):414-424. doi: 10.1093/ntr/ntx097. Nicotine Tob Res. 2018. PMID: 28498934 Free PMC article. Review.
-
Open access capture of patients with gastroesophageal reflux disease using an online patient-reported outcomes instrument.Interact J Med Res. 2012 Sep 26;1(2):e7. doi: 10.2196/ijmr.2101. Interact J Med Res. 2012. PMID: 23611985 Free PMC article.
Publication types
MeSH terms
LinkOut - more resources
Full Text Sources
Medical
Miscellaneous