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

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.