Ethical issues with the disclosure of surgical trial short-term data-Reference-Cited by-同舟云学术

Ethical issues with the disclosure of surgical trial short-term data

Published:2010-08-16 Issue:3 Volume:81 Page:125-131
ISSN:1445-1433
Container-title:ANZ Journal of Surgery
language:en
Short-container-title:

Author:

Allardyce Randall A.,Bagshaw Philip F.,Frampton Christopher M.,Frizelle Francis A.,Hewett Peter J.,Rieger Nicholas A,Smith J. Shona,Solomon Michael J.,Stevenson Andrew R. L.

Publisher

Wiley

Subject

General Medicine,Surgery

Link

http://onlinelibrary.wiley.com/wol1/doi/10.1111/j.1445-2197.2010.05433.x/fullpdf

Reference33 articles.

1. Damocles Study Group. Issues in data monitoring and interim analyses of trials;Grant;Health Technol. Assess.,2005

2. National Institutes of Health Policy for Data and Safety Monitoring 2009 http://www.grants.nih.gov/grants/guide/notice-files/not98-084.html

3. World Health Organisation Operational Guidelines for the Establishment and Functioning of Data and Safety Monitoring Boards 2009 http://apps.who.int/tdr/svc/publications/tdr-research-publications/operational-guidelines

4. European Medicines Agency, Committee for Medicinal Products for Human Use Guideline on Data Monitoring Committees 2009 http://www.emea.europa.eu/pdfs/human/ewp/587203en.pdf

5. FDA Guidance for clinical trial sponsors: On the establishment and operation of clinical trial data monitoring committees 2009 http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UMC127073.pdf

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