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Ethical issues with the disclosure of surgical trial short‐term data
Author(s) -
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.
Publication year - 2011
Publication title -
anz journal of surgery
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.426
H-Index - 70
eISSN - 1445-2197
pISSN - 1445-1433
DOI - 10.1111/j.1445-2197.2010.05433.x
Subject(s) - medicine , interim , clinical trial , psychological intervention , confidentiality , intensive care medicine , randomized controlled trial , interim analysis , perioperative , informed consent , data monitoring committee , medical physics , alternative medicine , surgery , nursing , archaeology , pathology , political science , law , history
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. Conclusion: 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.