Clinical trial data: Get them while you can

BMJ (Online)

Volumn 348, Issue , 2014, Pages

  Doshi, Peter ^a   Groves, Trish ^a   Loder, Elizabeth ^a  

^a BMJ ^*  (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

ACCESS TO INFORMATION; CLINICAL TRIAL (TOPIC); CONFIDENTIALITY; DRUG INDUSTRY; DRUG RESEARCH; EDITORIAL; EUROPE; EUROPEAN UNION; FINANCIAL MANAGEMENT; HEALTH CARE POLICY; HUMAN; INFORMATION DISSEMINATION; INFORMATION PROCESSING; INTERNET; OFF LABEL DRUG USE; PATIENT INFORMATION; PRACTICE GUIDELINE; PRESCRIPTION; PRIORITY JOURNAL; REGISTRATION;

EID: 84892141304     PISSN: None     EISSN: 17561833     Source Type: Journal    
DOI: 10.1136/bmj.g63     Document Type: Editorial

References (12)

1. European Commission. Proposal for a regulation of the European parliament and of the council on clinical trials on medicinal products for human use, and repealing directive 2001/20/EC. 2012. http://ec.europa.eu/health/files/ clinicaltrials/2012-07/proposal/2012-07-proposal-en.pdf.
2. European Commission. Health commissioner, Tonio Borg, welcomes agreement on the revision of EU rules on clinical trials. 2013. http://ec.europa.eu/ health/files/clinicaltrials/memo-13-1190-en.pdf
3. European Medicines Agency. Publication and access to clinical-trial data. 2013. www. ema.europa.eu/docs/en-GB/document-library/Other/2013/06/WC500144730. pdf.
4. National Academies. Project: strategies for responsible sharing of clinical trial data. 2013. www8.nationalacademies.org/cp/projectview.aspx?key= 49578
5. Food and Drug Administration. Food and Drug Administration Amendments Act of 2007. 2007. www.fda.gov/RegulatoryInformation/Legislation/ FederalFoodDrugandCosmeticActFDCAct/SignificantAmendmentstotheFDCAct/ FoodandDrugAdministrationAmendmentsActof2007/FullTextofFDAAALaw/default.htm
6. Doshi P, Jefferson T. Clinical study reports of randomised controlled trials: an exploratory review of previously confidential industry reports. BMJ Open 2013;3:e002496
7. Radley DC, Finkelstein SN, Stafford RS. Off-label prescribing among office-based physicians. Arch Intern Med 2006;166:1021-6
8. Doshi P. EFPIA-PhRMA's principles for clinical trial data sharing have been misunderstood. BMJ 2013;347:f5164
9. Doshi P. Transparency interrupted: the curtailment of the European Medicines Agency's policy on access to documents. JAMA Intern Med 2013;173:2009-11
10. Court of Justice of the European Union. Order of the vice-president of the court. 2013. http://curia.europa.eu/juris/document/document.jsf?text= &docid=145282&pageIndex=0&doclang=en&mode=req&dir=&occ= first&part=1&cid=877340
11. Court of Justice of the European Union. Order of the vice-president of the court. 2013. http://curia.europa.eu/juris/document/document.jsf?text= &docid=145281&pageIndex=0&doclang=en&mode=req&dir=&occ= first&part=1&cid=877683
12. European Medicines Agency. Send a question to the European Medicines Agency. 2014. www.ema.europa.eu/ema/index.jsp?curl=pages/about-us/landing/ask- ema-landing-page.jsp&mid