Big strides in Europe towards clinical trial transparency

BMJ (Online)

Volumn 349, Issue , 2014, Pages

  Groves, Trish ^a  

^a NONE   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

ACCESS TO INFORMATION; CLINICAL TRIAL (TOPIC); CONFIDENTIALITY; DRUG LEGISLATION; DRUG MARKETING; DRUG RESEARCH; EDITORIAL; EUROPE; GOVERNMENT REGULATION; HEALTH CARE POLICY; INFORMATION DISSEMINATION; PUBLIC HEALTH; RISK BENEFIT ANALYSIS; ETHICS;

CLINICAL TRIALS AS TOPIC; EUROPE; INFORMATION DISSEMINATION;

EID: 84908134214     PISSN: 09598146     EISSN: 17561833     Source Type: Journal    
DOI: 10.1136/bmj.g6276     Document Type: Editorial

References (12)

1. Eichler H-G, Abadie E, Breckenridge A, Leufkens H, Rasi G. Open clinical trial data for all? A view from regulators. PLoS Med 2012;9:e1001202.
2. Groves T, Weber W. Redacted policy on sharing drug trial data in Europe. BMJ 2014;348:g3561.
3. European Medicines Agency. European Medicines Agency policy on publication of clinical data for medicinal products for human use. Policy 0070. 2014. www.ema.europa.eu/docs/en-GB/document-library/Other/2014/10/WC500174796.pdf.
4. Regulation (EU) No 536/2014 of the European parliament and of the council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC. Official Journal of the European Union 2014. http://eur-lex.europa.eu/legalcontent/EN/TXT/?uri=uriserv:OJ.L-.2014.158.01.0001.01.ENG.
5. NHS Health Research Authority. HRA next steps - registration and reporting. 2014. www.hra.nhs.uk/documents/2014/04/hra-role-promote-transparency-hra-next-steps-positionpaper-comment-final.pdf.
6. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. Structure and content of clinical study reports: E3. 1995. www.ich.org/fileadmin/Public-Web-Site/ICH-Products/Guidelines/Efficacy/E3/E3-Guideline.pdf.
7. Doshi P, Jefferson T. Clinical study reports of randomised controlled trials: an exploratory review of previously confidential industry reports. BMJ Open 2013;3:e002496.
8. Wieseler B, Wolfram N, McGauran N, Kerekes MF, Vervölgyi V, Kohlepp P, et al. Completeness of reporting of patient-relevant clinical trial outcomes: comparison of unpublished clinical study reports with publicly available data. PLoS Med 2013;10:e1001526.
9. Jefferson T, Jones MA, Doshi P, Del Mar CB, Hama R, Thompson MJ, et al. Risk of bias in industry-funded oseltamivir trials: comparison of core reports versus full clinical study reports. BMJ Open 2014;4:e005253.
10. Food and Drug Administration. FDA amendments act (FDAAA) of 2007: public law No. 110-85 § 801. 2007.http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=110-cong-public-laws&docid=f:publ085.110.pdf.
11. NHS Health Research Authority. HRA and research transparency-registration. Key messages and Q and A. 2014. www.hra.nhs.uk/documents/2014/10/hra-researchtransparency-registration-key-messages-q.pdf.
12. International Committee of Medical Journal Editors. Recommendations for the conduct,1 reporting, editing, and publication of scholarly work in medical journals. 2013. www.icmje.org/icmje-recommendations.pdf.