Clinical trial transparency update: An assessment of the disclosure of results of company-sponsored trials associated with new medicines approved in Europe in 2012

Current Medical Research and Opinion

Volumn 31, Issue 7, 2015, Pages 1431-1435

  Rawal, Bina ^a   Deane, Bryan R ^b  

^a ASSOCIATION OF THE BRITISH PHARMACEUTICAL INDUSTRY   (United Kingdom)

^b NONE   (United Kingdom)

Author keywords

Clinical trials; Publication bias; Results disclosure; Transparency; Trial publication; Trial registration; Trial registries

Indexed keywords

ARTICLE; CLINICAL TRIAL (TOPIC); DRUG APPROVAL; DRUG INDUSTRY; EUROPE; EUROPEAN MEDICINES AGENCY; FOLLOW UP; HUMAN; INTERPERSONAL COMMUNICATION; PHASE 1 CLINICAL TRIAL (TOPIC); PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PHASE 4 CLINICAL TRIAL (TOPIC); SENSITIVITY ANALYSIS; PROCEDURES; REGISTER;

CLINICAL TRIALS AS TOPIC; DISCLOSURE; DRUG APPROVAL; EUROPE; HUMANS; REGISTRIES;

EID: 84934297019     PISSN: 03007995     EISSN: 14734877     Source Type: Journal    
DOI: 10.1185/03007995.2015.1047749     Document Type: Article

References (13)

1. Song F, Parekh S, Hooper L, et al. Dissemination and publication of research findings: an updated review of related biases. Health Technol Assess 2010; 14: 1-220
2. Rawal B, Deane BR. Clinical trial transparency and the evaluation of new medicines. Clin Invest 2014; 4: 587-90
3. Rawal B, Deane BR. Clinical trial transparency: an assessment of the disclosure of results of company-sponsored trials associated with new medicines approved recently in Europe. Curr Med Res Opin 2014; 30: 395-405
4. IFPMA Joint Position on the Disclosure of Clinical Trial Information via Clinical Trial Registries and Databases. Updated 10 November 2009. Available at: http://www.ifpma.org/fileadmin/content/Ethics/Clinical-Trials/Nov2009- Joint-Position-CT-Data-Disclosure-registries-and-databases.pdf [Last accessed 16 December 2014]
5. De Angelis C, Drazen JM, Frizelle FA, et al. Clinical trial registration: a statement from the International Committee of Medical Journal Editors. CMAJ 2004; 171: 606-7
6. Shin D. Reporting bias in clinical trials: what's the current status?. A Citeline White Paper. September 2014. Available at: http://www.citeline.com/ wp-content/uploads/Sept2014-Reporting-Bias-in-Clinical-Trials-Doro-Shin-Updated.pdf [Last accessed 16 December 2014]
7. Anderson ML, Chiswell K, Peterson ED, et al. Compliance with results reporting at ClinicalTrials.gov. N Engl J Med 2015; 372: 1031-9
8. Saito H, Gill CJ. How frequently do the results from completed US clinical trials enter the public domain?. - A statistical analysis of the ClinicalTrials.gov database. PLoS One 2014; 9: e101826
9. Bourgeois FT, Murthy S, Mandl KD. Outcome reporting among drug trials registered in ClinicalTrials.gov. Ann Intern Med 2010; 153: 158-66
10. European Union. 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 J Eur Union 2014; L158: 1-76
11. European Medicines Agency. European Medicines Agency policy on publication of clinical data for medicinal products for human use. Policy/0070. 2014. Available at: http://www.ema.europa.eu/docs/en-GB/document-library/ Other/2014/10/WC500174796.pdf [Last accessed 16 December 2014]
12. European Federation of Pharmaceutical Industries and Associations. Joint principles for responsible clinical trial data sharing 2013. Available at: http://transparency.efpia.eu/responsible-data-sharing [Last accessed 16 December 2014]
13. National Institutes of Health. Summary of HHS/NIH proposals to enhance transparency of clinical trial results. 2014. Available at: http://www.nih.gov/ news/health/nov2014/od-19-summary.htm [Last accessed 16 December 2014]