Enormous advances in surgical care have occurred over the last 50 years. Many changes were the result of clinical trials involving human subjects. Experiences such as the Tuskegee Syphilis Experiment identified a need for stringent oversight of human subjects research, while The Belmont Report of 1978 laid out a plan for ethical conduct of clinical trials.1 Furthermore, the research community has recognized the need for strict oversight of the scientific nature of the trials through the use of good clinical practice. Proper research design ensures that valid scientific information will be obtained as a result of patient participation in clinical trials. It is unethical to conduct a clinical trial if the scientific design precludes obtaining results that can be used to produce generalizable knowledge. As surgeons, we must ensure that our patients receive optimal care. We should seek every opportunity to contribute to the growing body of knowledge to ensure positive outcomes.
For patients with breast cancer, an axillary lymph node dissection (ALND) was the standard of care to assess and treat the axillary lymph nodes. In the 1980s and 1990s the possibility that the same diagnostic information could be obtained by sampling select nodes was explored. Early studies by Morton, Giuliano, Krag, and others described the technique of sentinel lymph node (SLN) surgery. To determine whether SLN surgery was as effective as ALND, the SLN surgery had to be tested in a larger group of surgeons. Several authors examined how many SLN operations needed to be performed to ensure that the surgeon was qualified to do the procedure.2-4 In clinical trials examining the effectiveness of SLN surgery, it was incumbent on the principal investigator (PI) to establish training and certification processes so that data obtained could be used to make a statement regarding whether SLN surgery was an acceptable alternative to ALND. If the ability of the surgeon to accurately obtain a SLN consistently was in question, meaningful results would not have been obtained. This requirement for training as a requirement for participating in a clinical trial begged the question of whether it was ethical to perform a new procedure on patients before it is an accepted part of routine care.5
In 2015, the American College of Surgeons published Operative Standards for Cancer Surgery. This book outlines the critical elements in performing cancer operations.6 Surgeons participating in clinical trials should be familiar with the steps required to perform the operations in a standardized manner. Of course, each patient is different, but the key maneuvers in these standards are applicable in most situations.
It is critical to standardize surgical technique among surgeons who participate in clinical trials. If the technique is new, the investigators must establish training guidelines and a process to monitor surgeon competence in the use of skills that were not developed as part of surgical training. Parameters for how many operations the surgeon is required to perform must be established with assessment of a defined outcome measure. In some cases, certification might be done by submitting a record of operative and pathology results. Alternatively, the surgeon might be required to submit videos that could be reviewed. For other operations, observation by a proctor can confirm that the surgeon is ready to perform the operation as part of a clinical trial.
Techniques and operations that are already part of the surgeon’s skills still need to be assessed to measure the surgeon’s ability to perform the operation in accordance with the requirements of the study. Some of this information might be obtained from case logs of operations done as part of routine clinical care with a measure of outcomes, often including the pathology report. An example may be the percentage of low anterior resections done in which the surgeon and pathologist retrieved 12 lymph nodes. Other outcomes, like patient complications, also may be evaluated.
To maintain the rigor of the study, the PI must budget for training, including providing funds to train sub-investigators or stipends for proctors.
Verification of credentials
Hospitals grant privileges for appropriately credentialed (board-certified or eligible) surgeons to perform operations, and the surgeon’s credentials should be verified. No surgeon should be allowed to perform an operation as part of a research study if he or she is not credentialed to do that operation. For new operations that require training, the institutional review board needs to approve the training and qualification plan, and the hospital needs to be aware and grant a specific privilege for the new skill.
Auditing individual surgeon results
Once the study begins, the PI must audit and monitor the surgical results. Similar to stopping rules for drug studies, rules must be in place to allow removal of a surgeon if he or she is unable to meet the technical requirements needed to ensure patient safety and the integrity of the data. A priori decisions need to be made with regard to whether the data from surgeons who are removed will be used in the final analysis of the results.
After trial completion, a decision needs to be made as to whether the surgeon can offer that operation outside the context of the study. New procedures may or may not become a new standard of practice. The question of what an individual surgeon can do off study, and when, is complex but should be addressed by the PI as well as local hospitals.
Participation in clinical trials requires that surgeons have proven capability and knowledge in the conduct of the research-related operations. Failure to do so may expose patients to risk and compromise the ability of the researcher team to test the study’s hypothesis.
- U.S. Department of Health and Human Services. The Belmont Report. March 15, 2016. Available at: www.hhs.gov/ohrp/regulations-and-policy/belmont-report/. Accessed July 27, 2016.
- Cox CE, Bass SS, Boulware D, Ku NK, Berman C, Reintgen DS. Implementation of new surgical technology: Outcome measures for lymphatic mapping of breast carcinoma. Ann Surg Oncol. 1999; 6(6):553-561.
- McMasters KM, Wong SL, Chao C, et al. Defining the optimal surgeon experience for breast cancer sentinel lymph node biopsy: A model for implementation of new surgical techniques. Ann Surg. 2001;234(3):292-299; discussion 299-300.
- Posther KE, McCall LM, Blumencranz, et al. Sentinel node skills verification and surgeon performance: Data from a multicenter clinical trial for early-stage breast cancer. Ann Surg. 2005;242(4):593-599; discussion 599-602.
- Sequeira R, Weinbaum F, Satterfield J, Chassin J, Mock L. Credentialing physicians for new technology: The physician’s learning curve must not harm the patient. Am Surg. 1994;60(11):821-823.
- Nelson H, Hunt KK, Blair S, et al (eds). Operative Standards For Cancer Surgery. Philadelphia, PA: Wolters Kluwer; 2015.