Association of Women Surgeons

Leigh Neumayer, MD, MS, FACS
Professor of Surgery 
University of Utah 
Salt Lake City VA Health Care System 
Salt Lake City, Utah

Clinical research ranges from case reports and case series at one end of the spectrum, to randomized clinical trials at the other. Participation in clinical trials is important as we transform to an evidence-based practice of surgery.

Clinical research refers to any kind of study that involves patients. Clinical research studies range from case reports and case series at one end of the spectrum to randomized clinical trials at the other. As surgery and medicine are transformed to evidence-based practice, clinical studies gain importance, especially randomized clinical trials. Participating in clinical studies is an important endeavor for all surgeons, whether they are in academic or private practice. Many large randomized trials in surgery have depended and will continue to depend on private surgeons to recruit and enroll patients. Reviewing one’s own outcomes in a clinical study (usually retrospective case series) is emerging as an important part of clinical practice, whether for re-certification or for acquiring patient referrals.

For some academic surgeons, clinical trials are the main focus of their scholarly pursuits. Such studies may take long periods of time to complete. For example, the large Veteran’s Affairs (VA) multi-center hernia trial required 2 years to plan, 5 years to execute, and over two years to analyze and publish all the results; it produced a total of 14 publications.

Many methods and opportunities are available to acquire skills as a clinical "trialist." It is possible to work in an already established laboratory, but this is not generally a key component of surgical clinical trials (unlike the basic sciences).  

• Participation in the Human Subjects Committee or Institutional Review Board (IRB) requires a significant commitment of time, but holds certain advantages. It is a good way to learn about clinical trials, the institution's interpretation of the regulations, and it also keeps participants informed as to which trials are ongoing and who the most active researchers are at the institution (potential source of a collaborator or mentor). Being known to the members of the IRB can be of assistance in getting your own proposals approved, and you will be more likely to be called if a question arises regarding your protocol, rather than the committee relying on their own interpretation of areas they may not fully understand.

• Enroll patients into ongoing studies. Departmental research nurses or coordinators are usually are knowledgeable about existing studies and can be helpful. If no pertinent studies are ongoing at your institution, consider participating in some that do not require your institution to be a funded center, such as American College of Surgeons (ACS) Oncology Group Trials. Details are available at: http://www.acosog.org/.  

• Human Subjects Training. Certification of human subjects training is now required on a yearly basis for all those involved in human research. Courses are available on-line, such as the CITI Collaborative IRB Training Program, licensed to the University of Miami (http://www.miami.edu/citireg), or the Human Participant Protections Education, for Research Teams sponsored by the National Cancer Institute. Further, many institutions, such as the VA, have their own specific requirements, VA training is accessed at http://vaww.ess.aac.gov. 

• Web resources. There is a wealth of information about conducting clinical trials on the Web, as well as information about ongoing clinical trials. See, for example, the National Cancer Institute site, http://www.cancer.gov/clinicaltrials. 

• Courses on conducting clinical trials. Consider enrolling in the ACS or VA Clinical Trials Courses. These courses have almost the same curriculum, except the ACS course is focused on surgeons/surgical trials. It requires an intensive 5 to 6 days (usually from 7:00 am to midnight), but the course gets great reviews and you will learn more in that week than you would in a year or two of trial and error. The American College of Surgeons (ACS) has developed a Clinical Methods course lasting an intensive 5 days. It is given in Chicago, has limited enrollment, and will next be offered in November 2007. More information is available at www.facs.org. These courses are expensive, so it is desirable to seek funding from your institution or from a grant. For information about the VA course, contact your VA Research Office.

• Masters Degrees. It is possible to tailor a program emphasizing clinical studies by working through a School of Public Health or other institution offering a Master of Public Health or Master of Health Administration. Several medical schools have training grants from the National Institutes of Health (NIH) to train clinical investigators; inquire at the medical school research office. Most MPH programs teach epidemiology research. Masters-level training in a subject allows one to converse more knowledgeably with PhD health services researchers and presents opportunities to collaborate that would not otherwise be available.

• A unique program is available through the University of Michigan School of Public Health On the Job/On Campus (OJ/OC) program, which allows pursuit of a Master’s degree while working. Master of Health Services Administration (MHSA), Master of Public Health (MPH), and Master of Science in Clinical Research Design and Statistical Analysis degrees are offered. These programs take almost 2 years and require a number of intensive four-day weekend class sessions in Ann Arbor. Course work includes classes in statistics, survey design, study design, human subjects’ protection, and more. The program is excellent and has a high success rate of its graduates achieving funding. Details are available at: http://www.sph.umich.edu/exec_ed/ojoc/index.html. 

• The book Fundamentals of Clinical Trials, Third Edition (1999 Springer) by Friedman, Furberg, and DeMets, is an excellent resource and is used in the ACS Clinical Trials course.

Society Membership

• The Society for Clinical Trials has an Annual Meeting, during which researchers of all types involved in clinical trials can attend. This meeting provides networking opportunities, as well as discussions of pitfalls of clinical trials. Details are available at: http://www.sctweb.org/. 

After acquiring the appropriate education to become a clinical trialist, further support is needed. Most clinical trials require at least a research assistant if not a research nurse. A PhD-level biostatistician also is often needed, and may be available through your department. Usually, whether within your department or not, the clinical trialist becomes responsible for the cost of this appropriate support. Other specialty help may be needed. For example, a study involving cost analysis should utilize the expertise of a health economist and a systems analysis requires a health sciences researcher. This is partly explains why clinical research is so expensive.  

One of the best places to do clinical trials and get them funded (if a multi-center trial is warranted) is the VA. To be eligible for the funding, the researcher must have at least a 5/8ths appointment (8/8ths means a full-time appointment) at the VA. The VA has a Cooperative Studies Program; details are available at: http://www.va.gov/resdev/csp.cfm. If you have an idea for a trial, prepare a 5-page “letter of intent” and send it to the head of Cooperative Studies in Washington, DC, who will send it out for review. If the reviewers believe it is a reasonable project to pursue, the Cooperative Studies Office will assign your proposal to one of the Cooperative Studies Centers staffed with biostatisticians, health services researchers, health economists, data managers, etc. The appropriate personnel will be assigned to help plan the study (although you can suggest a few other surgeons from the VA to participate), prepare the grant and, if and when the grant is approved and funded, they will help you with the trial. The Cooperative Studies Centers have vast experience with clinical trials in the VA, so they provide a huge resource. Another avenue to pursue is the Health Services Research and Development Service geared primarily toward systems and health services research. Details are available at: http://www.hsrd.research.va.gov/

Friedman, Furberg, and DeMets. Fundamentals of Clinical Research, Third Edition Springer, 1998.