Regulatory agencies hold the key to improving Cochrane reviews of drugs.
作者信息
Schroll Jeppe, Bero Lisa
机构信息
Department of Gynecology and Obstetrics, Hvidovre Hospital, Denmark.
出版信息
Cochrane Database Syst Rev. 2015 Apr 20;4(4):ED000098. doi: 10.1002/14651858.ED000098.
Abstract
摘要
相似文献
1
Regulatory agencies hold the key to improving Cochrane reviews of drugs.
Cochrane Database Syst Rev. 2015 Apr 20;4(4):ED000098. doi: 10.1002/14651858.ED000098.
2
Approval of Cancer Drugs With Uncertain Therapeutic Value: A Comparison of Regulatory Decisions in Europe and the United States.
Milbank Q. 2020 Dec;98(4):1219-1256. doi: 10.1111/1468-0009.12476. Epub 2020 Oct 6.
3
Multistakeholder Advice at the European Medicines Agency: Is It Still Needed?
Clin Pharmacol Ther. 2019 Apr;105(4):819-821. doi: 10.1002/cpt.1335. Epub 2019 Feb 27.
4
Commentary on Sood et al.: "Cochrane systematic reviews in acupuncture: methodological diversity in database searching".
J Altern Complement Med. 2005 Aug;11(4):723-4. doi: 10.1089/acm.2005.11.723.
5
Issues regarding systematic review reports and trial heterogeneity.
J Nerv Ment Dis. 2005 Jun;193(6):424-5; author reply 425-6. doi: 10.1097/01.nmd.0000165298.07731.6a.
6
Regulatory perspectives on data monitoring.
Stat Med. 2002 Oct 15;21(19):2831-42. doi: 10.1002/sim.1287.
7
Accelerated Approval of Anticancer Drugs: Lessons Learned From the Example of Olaratumab.
Clin Pharmacol Ther. 2021 Jul;110(1):29-31. doi: 10.1002/cpt.2081. Epub 2020 Nov 4.
8
The EMEA guideline on first-in-human clinical trials and its impact on pharmaceutical development.
Toxicol Pathol. 2009 Apr;37(3):363-71. doi: 10.1177/0192623309332997. Epub 2009 Feb 26.
9
Are the European Medicines Agency, US Food and Drug Administration, and Other International Regulators Talking to Each Other?
Clin Pharmacol Ther. 2020 Mar;107(3):507-513. doi: 10.1002/cpt.1617. Epub 2019 Oct 24.
10
Possible Contribution of Drug Approval Summaries Published by Drug Regulatory Authorities on Scientific Discussion and Drug Development.
Clin Pharmacol Drug Dev. 2020 Jan;9(1):6-10. doi: 10.1002/cpdd.744. Epub 2019 Oct 14.
引用本文的文献
1
How to use the regulatory data from Health Canada for secondary analyses on new drugs, biologics and vaccines.
BMJ Evid Based Med. 2024 May 22;29(3):187-193. doi: 10.1136/bmjebm-2023-112475.
2
Combined oral contraceptive pill for primary dysmenorrhoea.
Cochrane Database Syst Rev. 2023 Jul 31;7(7):CD002120. doi: 10.1002/14651858.CD002120.pub4.
3
Antipsychotics for agitation and psychosis in people with Alzheimer's disease and vascular dementia.
Cochrane Database Syst Rev. 2021 Dec 17;12(12):CD013304. doi: 10.1002/14651858.CD013304.pub2.
4
Pioglitazone for prevention or delay of type 2 diabetes mellitus and its associated complications in people at risk for the development of type 2 diabetes mellitus.
Cochrane Database Syst Rev. 2020 Nov 19;11(11):CD013516. doi: 10.1002/14651858.CD013516.pub2.
5
(Ultra-)long-acting insulin analogues versus NPH insulin (human isophane insulin) for adults with type 2 diabetes mellitus.
Cochrane Database Syst Rev. 2020 Nov 9;11(11):CD005613. doi: 10.1002/14651858.CD005613.pub4.
6
Targeted therapy for metastatic renal cell carcinoma.
Cochrane Database Syst Rev. 2020 Oct 14;10(10):CD012796. doi: 10.1002/14651858.CD012796.pub2.
7
Metformin monotherapy for adults with type 2 diabetes mellitus.
Cochrane Database Syst Rev. 2020 Jun 5;6(6):CD012906. doi: 10.1002/14651858.CD012906.pub2.
8
Oxandrolone for growth hormone-treated girls aged up to 18 years with Turner syndrome.
Cochrane Database Syst Rev. 2019 Oct 30;2019(10):CD010736. doi: 10.1002/14651858.CD010736.pub2.
9
Metformin and second- or third-generation sulphonylurea combination therapy for adults with type 2 diabetes mellitus.
Cochrane Database Syst Rev. 2019 Apr 18;4(4):CD012368. doi: 10.1002/14651858.CD012368.pub2.
10
Short-acting insulin analogues versus regular human insulin for adult, non-pregnant persons with type 2 diabetes mellitus.
Cochrane Database Syst Rev. 2018 Dec 17;12(12):CD013228. doi: 10.1002/14651858.CD013228.
本文引用的文献
1
The Food and Drug Administration reports provided more data but were more difficult to use than the European Medicines Agency reports.
J Clin Epidemiol. 2015 Jan;68(1):102-7. doi: 10.1016/j.jclinepi.2014.06.019. Epub 2014 Aug 20.
2
How to access and process FDA drug approval packages for use in research.
BMJ. 2013 Oct 14;347:f5992. doi: 10.1136/bmj.f5992.
3
Searching for unpublished data for Cochrane reviews: cross sectional study.
BMJ. 2013 Apr 23;346:f2231. doi: 10.1136/bmj.f2231.
4
Compliance with mandatory reporting of clinical trial results on ClinicalTrials.gov: cross sectional study.
BMJ. 2012 Jan 3;344:d7373. doi: 10.1136/bmj.d7373.
5
Effect of reporting bias on meta-analyses of drug trials: reanalysis of meta-analyses.
BMJ. 2012 Jan 3;344:d7202. doi: 10.1136/bmj.d7202.
6
Full publication of results initially presented in abstracts.
Cochrane Database Syst Rev. 2007 Apr 18(2):MR000005. doi: 10.1002/14651858.MR000005.pub3.
Zotero 插件