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

Allardyce, Randall A., Bagshaw, Philip F., Frampton, Christopher M., Frizelle, Francis A., Hewett, Peter J., Rieger, Nicholas A., Smith, J. Shona, Solomon, Michael J. and Stevenson, Andrew R. L. (2011) Ethical issues with the disclosure of surgical trial short-term data. ANZ Journal of Surgery, 81 3: 125-131. doi:10.1111/j.1445-2197.2010.05433.x

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.
Title Ethical issues with the disclosure of surgical trial short-term data
Journal name ANZ Journal of Surgery   Check publisher's open access policy
ISSN 1445-1433
Publication date 2011-03-01
Sub-type Article (original research)
DOI 10.1111/j.1445-2197.2010.05433.x
Volume 81
Issue 3
Start page 125
End page 131
Total pages 7
Place of publication Richmond, VIC, Australia
Publisher Wiley-Blackwell Publishing Asia
Language eng
Formatted abstract
Background:  This paper describes the distinctions between major surgical and pharmaceutical trials and questions the application of a common ethical paradigm to guide their conduct and reporting.

Methods:  Surgical trials differ from other trials in cumulative therapeutic effects, operator dependence, the clinical setting, interdependence of short- and long-term outcomes, and equipoise. A principal tenant of randomized controlled trial management is the maintenance of interim data confidentiality. Its application to complete surgical short-term data is examined across a variety of common clinical trial circumstances that influence data integrity and the reliability of conclusions regarding the benefit-to-risk profile of experimental interventions.

Results:  Complete perioperative results describe important treatment ends that cannot influence primary outcomes. These short-term results may inform patient consent, teaching and provide valuable procedural insights to surgeons outside trial precincts.

Structured experimentation standards are necessary. But, the common paradigm applied across all clinical trials and the prohibition on short term data reporting may not serve the achievement of safe and effective advancements in surgery.
Keyword Confirmatory evidence
Data monitoring committee
Monitoring guideline
Randomized controlled trial
Surgery research
Q-Index Code C1
Q-Index Status Provisional Code
Institutional Status Non-UQ

Document type: Journal Article
Sub-type: Article (original research)
Collection: School of Medicine Publications
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Created: Mon, 10 Sep 2012, 18:15:17 EST by Andrew Stevenson on behalf of School of Medicine