伦理官僚作风：儿童罕见病药物疗效协作随访的重大障碍。 - Suppr

Suppr

超能文献

Ethics bureaucracy: a significant hurdle for collaborative follow-up of drug effectiveness in rare childhood diseases.

作者信息

Hansson Mats G, Gattorno Marco, Forsberg Joanna Stjernschantz, Feltelius Nils, Martini Alberto, Ruperto Nicolino

出版信息

Arch Dis Child. 2012 Jun;97(6):561-3. doi: 10.1136/archdischild-2011-301175. Epub 2012 Feb 22.

DOI:10.1136/archdischild-2011-301175

PMID:22362719

Abstract

摘要

相似文献

Ethics bureaucracy: a significant hurdle for collaborative follow-up of drug effectiveness in rare childhood diseases.

Arch Dis Child. 2012 Jun;97(6):561-3. doi: 10.1136/archdischild-2011-301175. Epub 2012 Feb 22.

Development of medicines for children in Europe: ethical implications.

Paediatr Respir Rev. 2005 Mar;6(1):45-51. doi: 10.1016/j.prrv.2004.11.008.

Avoiding clinical trials in children.

Arch Dis Child. 2011 Mar;96(3):291-2. doi: 10.1136/adc.2010.203737. Epub 2011 Jan 23.

The ethics of non-inferiority trials.

Lancet. 2008 Mar 15;371(9616):896; author reply 896-7. doi: 10.1016/S0140-6736(08)60408-0.

Testing medications in children.

N Engl J Med. 2002 Oct 31;347(18):1462-70. doi: 10.1056/NEJMhpr021646.

Orphan drugs revisited.

QJM. 2006 May;99(5):341-5; discussion 350-1. doi: 10.1093/qjmed/hcl033. Epub 2006 Feb 27.

How to Overcome Scientific Standstill for Very Rare Diseases: Clinical Trials or Clinical Registries?

Klin Padiatr. 2015 Nov;227(6-7):303-4. doi: 10.1055/s-0035-1565135. Epub 2015 Nov 24.

[Ethical aspects of conducting clinical studies in children. An instrumentation loser?].

Pharm Unserer Zeit. 2009;38(1):68-73. doi: 10.1002/pauz.200800298.

Experts ponder pediatric research ethics.

JAMA. 2005 Nov 2;294(17):2148-51. doi: 10.1001/jama.294.17.2148.

Assent in pediatric research.

Pediatrics. 2006 Oct;118(4):1800-1; author reply 1801. doi: 10.1542/peds.2006-1577.

引用本文的文献

Ethical Questions Linked to Rare Diseases and Orphan Drugs - A Systematic Review.

Risk Manag Healthc Policy. 2020 Oct 13;13:2125-2148. doi: 10.2147/RMHP.S260641. eCollection 2020.

Ethical issues related to clinical research and rare diseases: 15th Gordon L. Snider Critical Issues Workshop, April 1, 2016, Bethesda, Maryland.

Transl Sci Rare Dis. 2017 Dec 18;2(3-4):175-194. doi: 10.3233/TRD-170013.

The risk of re-identification versus the need to identify individuals in rare disease research.

Eur J Hum Genet. 2016 Nov;24(11):1553-1558. doi: 10.1038/ejhg.2016.52. Epub 2016 May 25.

Optimizing treatment in paediatric rheumatology--lessons from oncology.

Nat Rev Rheumatol. 2015 Aug;11(8):493-9. doi: 10.1038/nrrheum.2015.50. Epub 2015 Apr 21.

International Charter of principles for sharing bio-specimens and data.

Eur J Hum Genet. 2015 Jun;23(6):721-8. doi: 10.1038/ejhg.2014.197. Epub 2014 Sep 24.

Modernising the regulation of medical migration: moving from national monopolies to international markets.

BMC Med Ethics. 2012 Oct 5;13:26. doi: 10.1186/1472-6939-13-26.

Where should we draw the line between quality of care and other ethical concerns related to medical registries and biobanks?

Theor Med Bioeth. 2012 Aug;33(4):313-23. doi: 10.1007/s11017-012-9229-x.

文献AI研究员

20分钟写一篇综述，助力文献阅读效率提升50倍。

立即体验

用中文搜PubMed

大模型驱动的PubMed中文搜索引擎

马上搜索

文档翻译

学术文献翻译模型，支持多种主流文档格式。

立即体验

相似文献

Ethics bureaucracy: a significant hurdle for collaborative follow-up of drug effectiveness in rare childhood diseases.

Arch Dis Child. 2012 Jun;97(6):561-3. doi: 10.1136/archdischild-2011-301175. Epub 2012 Feb 22.

Development of medicines for children in Europe: ethical implications.

Paediatr Respir Rev. 2005 Mar;6(1):45-51. doi: 10.1016/j.prrv.2004.11.008.

Avoiding clinical trials in children.

Arch Dis Child. 2011 Mar;96(3):291-2. doi: 10.1136/adc.2010.203737. Epub 2011 Jan 23.

The ethics of non-inferiority trials.

Lancet. 2008 Mar 15;371(9616):896; author reply 896-7. doi: 10.1016/S0140-6736(08)60408-0.

Testing medications in children.

N Engl J Med. 2002 Oct 31;347(18):1462-70. doi: 10.1056/NEJMhpr021646.

Orphan drugs revisited.

QJM. 2006 May;99(5):341-5; discussion 350-1. doi: 10.1093/qjmed/hcl033. Epub 2006 Feb 27.

How to Overcome Scientific Standstill for Very Rare Diseases: Clinical Trials or Clinical Registries?

Klin Padiatr. 2015 Nov;227(6-7):303-4. doi: 10.1055/s-0035-1565135. Epub 2015 Nov 24.

[Ethical aspects of conducting clinical studies in children. An instrumentation loser?].

Pharm Unserer Zeit. 2009;38(1):68-73. doi: 10.1002/pauz.200800298.

Experts ponder pediatric research ethics.

JAMA. 2005 Nov 2;294(17):2148-51. doi: 10.1001/jama.294.17.2148.

Assent in pediatric research.

Pediatrics. 2006 Oct;118(4):1800-1; author reply 1801. doi: 10.1542/peds.2006-1577.

引用本文的文献

Ethical Questions Linked to Rare Diseases and Orphan Drugs - A Systematic Review.

Risk Manag Healthc Policy. 2020 Oct 13;13:2125-2148. doi: 10.2147/RMHP.S260641. eCollection 2020.

Ethical issues related to clinical research and rare diseases: 15th Gordon L. Snider Critical Issues Workshop, April 1, 2016, Bethesda, Maryland.

Transl Sci Rare Dis. 2017 Dec 18;2(3-4):175-194. doi: 10.3233/TRD-170013.

The risk of re-identification versus the need to identify individuals in rare disease research.

Eur J Hum Genet. 2016 Nov;24(11):1553-1558. doi: 10.1038/ejhg.2016.52. Epub 2016 May 25.

Optimizing treatment in paediatric rheumatology--lessons from oncology.

Nat Rev Rheumatol. 2015 Aug;11(8):493-9. doi: 10.1038/nrrheum.2015.50. Epub 2015 Apr 21.

International Charter of principles for sharing bio-specimens and data.

Eur J Hum Genet. 2015 Jun;23(6):721-8. doi: 10.1038/ejhg.2014.197. Epub 2014 Sep 24.

Modernising the regulation of medical migration: moving from national monopolies to international markets.

BMC Med Ethics. 2012 Oct 5;13:26. doi: 10.1186/1472-6939-13-26.

Where should we draw the line between quality of care and other ethical concerns related to medical registries and biobanks?

Theor Med Bioeth. 2012 Aug;33(4):313-23. doi: 10.1007/s11017-012-9229-x.