North American regulatory agencies can and should make clinical trial data publicly available

CMAJ

Volumn 188, Issue 2, 2016, Pages 96-97

  Persaud, Nav ^a,b   Doshi, Peter ^a,c  

^a ST MICHAEL'S HOSPITAL   (Canada)

^b UNIVERSITY OF TORONTO   (Canada)

^c UNIVERSITY OF MARYLAND SCHOOL OF PHARMACY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

AGOMELATINE; OSELTAMIVIR;

CANADA; CANADIAN; CLINICAL TRIAL (TOPIC); DEPRESSION; DRUG COST; DRUG INDUSTRY; FOOD AND DRUG ADMINISTRATION; HEALTH CARE DELIVERY; LAW; MEDICAL RESEARCH; NORTH AMERICAN; NOTE; PATIENT CARE; UNITED STATES; WORLD HEALTH ORGANIZATION; GOVERNMENT REGULATION; INFORMATION DISSEMINATION; INTERPERSONAL COMMUNICATION; LEGISLATION AND JURISPRUDENCE; NORTH AMERICA;

CLINICAL TRIALS AS TOPIC; DISCLOSURE; GOVERNMENT REGULATION; INFORMATION DISSEMINATION; NORTH AMERICA;

EID: 84957085241     PISSN: 08203946     EISSN: 14882329     Source Type: Journal    
DOI: 10.1503/cmaj.150679     Document Type: Note

References (12)

1. Chan AW, Song F, Vickers A, et al. Increasing value and reducing waste: Addressing inaccessible research. Lancet 2014;383: 257-66.
2. World Medical Association. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA 2013;310:2191-4.
3. Chalmers I. Underreporting research is scientific misconduct. JAMA 1990;263:1405-8.
4. Herder M. Unlocking Health Canadas cache of trade secrets: mandatory disclosure of clinical trial results. CMAJ 2012;184: 194-9.
5. Kesselheim AS, Mello MM. Confidentiality laws and secrecy in medical research: improving public access to data on drug safety. Health Aff (Millwood) 2007;26:483-91.
6. Koesters M, Guaiana G, Cipriani A, et al. Agomelatine efficacy and acceptability revisited: systematic review and meta-Analysis of published and unpublished randomised trials. Br J Psychiatry 2013;203: 179-87.
7. Jefferson T, Jones M, Doshi P, et al. Oseltamivir for influenza in adults and children: systematic review of clinical study reports and summary of regulatory comments. BMJ 2014;348:g2545.
8. Methods guide for effectiveness and comparative effectiveness review. Rockville (MD): Agency for Healthcare Research and Quality; 2014. Available: www.effectivehealthcare.ahrq.gov/ehc/products/60/318/CER-Methods-Guide-140109.pdf (accessed 2015 Sept. 22).
9. Gotzsche PC, Jorgensen AW. Opening up data at the European Medicines Agency. BMJ 2011;342:1184-6.
10. European Medicines Agency policy on publication of clinical data for medicinal products for human use. Policy/0070. London: European Medicines Agency; 2015. Available: www.ema.europa. eu/docs/en-GB/document-library/Other/2014/10/WC500174796. pdf (accessed 2015 Sept. 22).
11. Open government [homepage]. Ottawa: Government of Canada; 2013. Available: http://open.canada.ca/en (accessed 2015 June 12).
12. About FDA: Transparency [web page]. Silver Spring (MD): US Food and Drug Administration; 2015. Available: www.fda.gov/AboutFDA/Transparency/(accessed 2015 Apr. 28).