FDA official: "Clinical trial system is broken"

BMJ (Online)

Volumn 347, Issue , 2013, Pages

  Cohen, Deborah ^a  

^a BMJ   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

EPLERENONE; LOSARTAN; PLACEBO; ROSIGLITAZONE; TICAGRELOR; VALSARTAN;

ARTICLE; CLINICAL RESEARCH; DIABETES MELLITUS; DRUG EFFICACY; DRUG INDUSTRY; DRUG MARKETING; DRUG RESEARCH; DRUG SAFETY; EXPERIMENTAL DESIGN; FOOD AND DRUG ADMINISTRATION; HEALTH CARE PERSONNEL; HEART FAILURE; HUMAN; HYPERTENSION; LICENSING; LUNG CANCER; PRIORITY JOURNAL; PROCESS DEVELOPMENT; QUALITY CONTROL; RISK ASSESSMENT;

CLINICAL TRIALS AS TOPIC; DRUG APPROVAL; ENDPOINT DETERMINATION; GREAT BRITAIN; HUMANS; HYPOGLYCEMIC AGENTS; RESEARCH DESIGN; THIAZOLIDINEDIONES; UNITED STATES;

EID: 84890040055     PISSN: None     EISSN: 17561833     Source Type: Journal    
DOI: 10.1136/bmj.f6980     Document Type: Article

References (12)

1. Herper M. Battleground FDA: how tomorrow's Avandia panel could shape the future of diabetes. Forbes 2013 Jun 4. www.forbes.com/sites/matthewherper/2013/ 06/04/battleground-fda-how-tomorrows-avandia-panel-could-help-shape-the-future- of-diabetes/.
2. Cohen D. US lawyers investigate trial that secured license for AstraZeneca's antiplatelet drug. BMJ 2013; 347: f6727.
3. Pitt B, Remme W, Zannad F, Neaton J, Martinez F, Roniker B, et al. Eplerenone, a selective aldosterone blocker, in patients with left ventricular dysfunction after myocardial infarction. N Engl J Med 2003; 348: 1309-21. (Pubitemid 36384098)
4. FDA: Clinical review eplereone. www.accessdata.fda.gov/drugsatfda-docs/ nda/2003/21- 437S002-Inspra-Medr-P2.pdf.
5. Neale T. Problems found in PLATO trial results. MedPage Today 2013 Aug 5. www. medpagetoday.com/Cardiology/AcuteCoronarySyndrome/40841.
6. Center for Drug Evaluation and Research. Application No 022433Orig1s000. Medical reviews. www.accessdata.fda.gov/drugsatfda-docs/nda/2011/ 022433Orig1s000MedR. pdf.
7. Burton TM. Dispute flares inside FDA over safety of popular blood-pressure drugs. Wall Street Journal 2013 May 30. http://online.wsj.com/ article/SB10001424127887324682204578515172395384146.html?mod=WSJ-hps- LEFTTopStories#articleTabs%3Darticle.
8. Sipahi I, Debanne SM, Rowland DY, Simon DI, Fang JC. Angiotensin-receptor blockade and risk of cancer: meta-analysis of randomised controlled trials. Lancet Oncol 2010; 11: 627-36.
9. Dombrowski C. Avandia review endorsement aided by good data, cultural shift on safety. Pink Sheet 2013 Jun 17.
10. Home PD, Pocock SJ, Beck-Nielsen H, Curtis PS, Gomis R, Hanefeld M, et al. Rosiglitazone evaluated for cardiovascular outcomes in oral agent combination therapy for type 2 diabetes (RECORD): a multicentre, randomised, open-label trial. Lancet 2009; 373: 2125-35.
11. Cohen D. Rosiglitazone: what went wrong? BMJ 2010; 341: c4848.
12. Tucker ME. FDA panel advises easing restrictions on rosiglitazone. BMJ 2013; 346: f3769.