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Comment

. 2017 Feb 6;189(5):E185-E186.

doi: 10.1503/cmaj.161088. Epub 2016 Nov 14.

Secrecy or transparency? The future of regulatory trial data

Beate Wieseler¹, Natalie McGauran²

Affiliations

Affiliations

¹ Institute for Quality and Efficiency in Health Care, Cologne, Germany beate.wieseler@iqwig.de.
² Institute for Quality and Efficiency in Health Care, Cologne, Germany.

PMID: 28246263
PMCID: PMC5289868
DOI: 10.1503/cmaj.161088

Comment

Secrecy or transparency? The future of regulatory trial data

Beate Wieseler et al. CMAJ. 2017.

. 2017 Feb 6;189(5):E185-E186.

doi: 10.1503/cmaj.161088. Epub 2016 Nov 14.

Authors

Beate Wieseler¹, Natalie McGauran²

Affiliations

¹ Institute for Quality and Efficiency in Health Care, Cologne, Germany beate.wieseler@iqwig.de.
² Institute for Quality and Efficiency in Health Care, Cologne, Germany.

PMID: 28246263
PMCID: PMC5289868
DOI: 10.1503/cmaj.161088

No abstract available

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Comment on

Considering benefits and harms of duloxetine for treatment of stress urinary incontinence: a meta-analysis of clinical study reports.
Maund E, Guski LS, Gøtzsche PC. Maund E, et al. CMAJ. 2017 Feb 6;189(5):E194-E203. doi: 10.1503/cmaj.151104. Epub 2016 Nov 14. CMAJ. 2017. PMID: 28246265 Free PMC article.

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References

1. Maund E, Schow Guski L, Gøtzsche PC. Considering benefits and harms of duloxetine for treatment of stress urinary incontinence: a meta-analysis of clinical study reports. CMAJ 2017;189:E194–203. - PMC - PubMed
1. European Medicines Agency policy on access to documents (related to medicinal products for human and veterinary use) — policy/0043. EMA/110196/2006. London (UK): European Medicines Agency; 2010. Available: www.ema.europa.eu/docs/en_GB/document_library/Other/2010/11/WC500099473.pdf (accessed 2016 Aug. 19).
1. Gøtzsche PC, Jørgensen AW. Opening up data at the European Medicines Agency. BMJ 2011;342:d2686. - PubMed
1. European Medicines Agency policy on publication of clinical data for medicinal products for human use — policy/0070. EMA/240810/2013. London (UK): European Medicines Agency; 2014. Available: www.ema.europa.eu/docs/en_GB/document_library/Other/2014/10/WC500174796.pdf (accessed 2016 Aug. 19).
1. Wieseler B, Kerekes MF, Vervoelgyi V, et al. Impact of document type on reporting quality of clinical drug trials: a comparison of registry reports, clinical study reports, and journal publications. BMJ 2012;344:d8141. - PubMed

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