Reducing Bureaucracy in Clinical Research: A Call for Action
- PMID: 32309789
- PMCID: PMC7162089
- DOI: 10.1097/HS9.0000000000000352
Reducing Bureaucracy in Clinical Research: A Call for Action
Conflict of interest statement
Competing interests: Pieter Sonneveld is member of the EHA executive board, EHA past president, member of the EHA Education Committee, member of the European Affairs Committee, member of the Research committee, member of the Sponsor and Fundraising Committee, and chair of the SWG Committee. Martin Dreyling is member of the EHA executive board, member of the SWG Committee and vice-chair of the EHA Guidelines Committee. Elizabeth Macintyre is president elect of EHA and member of the European Affairs Committee. John Gribben is president of EHA and member of the European Affairs Committee. Ulrich Jäger is member of EHA European Affairs Committee.
References
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- European Commission. Regulation (EU) No 536/2014 of the European Parliament and of the Council on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC. 16 April 2014. https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-1/reg_... [Accessed December 3, 2019].
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- European Commission. Directive 2001/20/EC of the European Parliament and of the Council on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. 4 April 2001. https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-1/dir_... [Accessed November 11, 2019]. - PubMed
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- Hearn J, Sullivan R. The impact of the ‘clinical trials’ directive on the cost and conduct of non-commercial cancer trials in the UK. Eur J Cancer. 2007;43:8–13. - PubMed
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- Sekeres M. Contract research agonizations. Editor's corner, perspectives. ASH Clinical News, 2017. https://www.ashclinicalnews.org/perspectives/editors-corner/contract-res... [Accessed November 6, 2019].
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