The European medicines agency and publication of clinical study reports a challenge for the US FDA

JAMA - Journal of the American Medical Association

Volumn 317, Issue 9, 2017, Pages 905-906

  Davis, Anna L ^a   Miller, James Dabney ^a  

^a JOHNS HOPKINS BLOOMBERG SCHOOL OF PUBLIC HEALTH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ATALUREN; CARFILZOMIB; LESINURAD; OSELTAMIVIR;

ACCESS TO INFORMATION; CONFIDENTIALITY; DRUG CONTROL; DRUG INDUSTRY; DRUG RESEARCH; EUROPEAN MEDICINES AGENCY; FOOD AND DRUG ADMINISTRATION; LAW SUIT; POLICY; PRIVACY; PUBLICATION; PUBLISHING; SHORT SURVEY; UNITED STATES; CLINICAL TRIAL (TOPIC); DRUG APPROVAL; EUROPE; HUMAN; INTERPERSONAL COMMUNICATION;

CLINICAL TRIALS AS TOPIC; DISCLOSURE; DRUG APPROVAL; DRUG INDUSTRY; EUROPE; HUMANS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 85015827442     PISSN: 00987484     EISSN: 15383598     Source Type: Journal    
DOI: 10.1001/jama.2017.0918     Document Type: Short Survey

References (9)

1. 21 CFR 314.126(b)(1): Protocol; 314.126(b)(2): Placebo or active controls; 312.21: Phases of clinical investigations; 50.20: Consent of patients.
2. European Medicines Agency. Policy No. 0043: Access to documents related to medicinal products for human and veterinary use. http://www.ema .europa.eu/docs/en-GB/document-library/Other/2010/11/WC500099473.pdf. Accessed November 9, 2016.
3. Doshi P, Jefferson T. Open data 5 years on: A case series of 12 freedom of information requests for regulatory data to the European Medicines Agency. Trials. 2016;17:78.
4. Jefferson T, JonesM, Doshi P, Spencer EA, Onakpoya I, Heneghan CJ. Oseltamivir for influenza in adults and children: Systematic review of clinical study reports and summary of regulatory comments. BMJ. 2014;348:g2545.
5. Dobson J, Whitley RJ, Pocock S, Monto AS. Oseltamivir treatment for influenza in adults: Ameta-analysis of randomised controlled trials. Lancet. 2015;385(9979):1729-1737.
6. European Medicines Agency. Policy No. 0070: Publication of clinical data for medicinal products for human use. http://www.ema.europa.eu/docs/en-GB/document-library/Other/2014/10/WC500174796.pdf. Accessed November 6, 2016.
7. European Union General Court. PTC Therapeutics v EMA, docket T-718/15 R (interim injunction issued July 20, 2016).
8. US Food and Drug Administration. Guidance for industry: E3 structure and content of clinical study reports. http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm336889.pdf. Accessed November 6, 2016.
9. US Food and Drug Administration. FDA transparency initiative: Draft proposals for public comment regarding disclosure policies of the US Food and Drug Administration. http://www.fda.gov/downloads/AboutFDA/Transparency/PublicDisclosure/GlossaryofAcronymsandAbbreviations/UCM212110.pdf. Accessed November 6, 2016.