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Randomized controlled trials in surgical oncology: where do we stand?
Kellie L Mathis1, Heidi Nelson
1Department of Surgery, Division of Colon and Rectal Surgery, Mayo Clinic, 200 First Street SW, Rochester, MN 55905, USA. mathis.kellie@mayo.edu
Clinical trials in breast cancer surgery have significantly improved patient care. However, advancements in rectal cancer surgery often occurred outside of formal trials, highlighting the need for better implementation of surgical trial findings.
Area of Science:
- Surgical Oncology
- Clinical Trial Methodology
- Evidence-Based Medicine
Background:
- Clinical trials are crucial for advancing surgical practices.
- Breast cancer surgery has been significantly transformed by clinical trials.
- Rectal cancer surgery evolution has largely occurred outside of formal clinical trials.
Purpose of the Study:
- To review the history and impact of clinical trials in surgical oncology.
- To examine the strengths and limitations of surgical clinical trials.
- To propose improvements for future surgical trial design and implementation.
Main Methods:
- Historical review of surgical clinical trials.
- Case study analysis using breast and rectal cancer surgery.
- Discussion of trial limitations and implementation gaps.
Main Results:
- Breast cancer surgical management has been profoundly impacted by clinical trials.
- Rectal cancer surgical advancements have frequently occurred outside of trial settings.
- Surgical trials face challenges in surgeon participation and clinical practice integration.
Conclusions:
- Future surgical trials should mandate pretrial credentialing for surgeons.
- Bridging the gap between trial results and clinical practice implementation is essential.
- Enhancing the design and adoption of surgical trials can improve patient outcomes.
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