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The difference between study recommendations, stated policy, and actual practice in a clinical trial
1National Cancer Institute of Canada, Clinical Trials Group, Kingston, Ontario, Canada. jgoffin@tufts-nemc.org
Summary
Physicians in a clinical trial showed higher adherence to study recommendations for boost radiation after breast conserving surgery than to their institution's stated policy. This suggests trial protocols should align with standard practices.
Area of Science:
- Oncology
- Radiation Oncology
- Clinical Trials
Background:
- Investigating physician adherence to clinical trial protocols versus institutional policies for boost radiation therapy post-breast conserving surgery.
- Assessing compliance in the context of breast or breast plus nodal radiation trials in Canada.
Purpose of the Study:
- To determine if physicians follow study recommendations or their treatment center's stated policy for boost radiation.
- To compare adherence rates between study guidelines and local protocols.
Main Methods:
- Survey of boost radiation treatment policy at 25 Canadian oncology centers participating in a randomized trial.
- Comparison of actual patient treatment practices against stated institutional policies and study recommendations.
Main Results:
- 81% of 248 subjects received treatment per stated policy (fair to moderate agreement).
- 94% of subjects were treated according to study recommendations (moderate to near substantial agreement).
- Invasive disease at resection margins significantly increased likelihood of receiving boost radiation (OR 49).
Conclusions:
- Physicians demonstrated greater compliance with study recommendations than with local policies for boost radiation.
- Clinical trial protocols may need to integrate standard treatment practices for better adherence.
- Findings highlight potential discrepancies between trial design and routine clinical practice.