Vascular surgery has evolved into a specialty that is highly dependent on medical devices to provide optimal care for our patients. A large percentage of practices use wire and catheter techniques to treat aneurysmal and occlusive disease in many different vascular beds. The exposure to medical device companies makes a vascular surgeon highly susceptible to violating the appropriate physician-industry relationship. This article provides some suggestions on how to handle the complex situation of advancing your career, your practice, and device development while not putting yourself at risk of inappropriate personal gain. I will focus my comments on clinical trial work, educational grants, and consulting work.

CLINICAL TRIAL WORK

Clinical trial work is typically straightforward. The sponsor of the study usually interacts directly with your institution through a research coordinator. The research coordinator is usually an employee of the department of surgery or division of vascular surgery, although sometimes he or she is a hospital employee.The initial approach is a site survey that gauges your interest in participating in a clinical trial. The site-survey also allows the sponsor to determine if you have adequate patient volume to support their trial at your site. I would recommend being as accurate as possible when categorizing your patient volume and completing the site-survey forms. It is more detrimental to your future involvement as an investigator with a sponsor if you are not able to participate in a clinical trial when you provided data that stated you would easily be able to enroll patients.

If your site is selected and you are selected as a site principal investigator (PI), the next step is completion of a nondisclosure agreement (NDA), which needs to be signed by you and your institution. The NDA allows the sponsor to share specifics of the study design with the PI and the participating site. It also may provide details about the specifics of the device that will be used in the study. The protocol and institutional review board (IRB) submission process can then begin. An important IRB detail for sponsors is how quickly your IRB is able to process submissions. IRB fees are also institution dependent and can be an issue in becoming an active clinical trial site. Finally, a contract needs to be negotiated between your institution and the study sponsor.

A significant aspect of clinical trial work as it pertains to the physician-industry relationship is any involvement you may have with the sponsor of the study that may be viewed as a conflict of interest to the study outcome. Each institution defines conflict of interest based on institutional policies. Either way, your site can participate in a study even if you have received compensation for consulting work or other projects, as long as you carefully disclose your conflicts. As the PI, you may not be able to participate in the clinical work, and you may need to remove yourself from the study completely if you have conflicts. It is not worth compromising your career or the outcome of a study because you think you can manage your conflict yourself. Be honest in your disclosures, and allow your institution to assist in defining what is perceived as a conflict of interest when leading a clinical trial at your site. Most institutions will ask you to provide an updated disclosure on an annual basis. You may have to change your role or involvement in a study if your disclosure statement changes.

EDUCATIONAL GRANTS

The financial situation at most medical centers has made the development of clinical programs more difficult and has limited our ability to support academic endeavors. Many departments have discretionary funds from clinical revenue that are available to support your vascular surgery program, but these funds are not as readily available as they were a decade ago. It is an easy trap to turn to industry to support programs when the resources are more readily available from industry than from your department. You must use care when trying to obtain this type of financial support.

Educational grants can support research, resident and fellow educational opportunities, and lectureship series. An educational grant should not have any dependence on the clinical volume or amount of devices you use from a particular sponsor. Most educational grants require an application and explanation of the necessity of educational support. The grant application is usually for a specific amount of support. A grant that is funded will be awarded to the institution and not to an individual. I would suggest using the department of surgery as a depot for the financial support that comes from educational grants, but this can be handled according to the policies of your department. As long as you do not receive individual financial gain, you do not need to disclose this as part of your individual annual disclosure statement.

CONSULTING WORK

The issue of consulting can be more controversial than clinical trial work or educational grants, but it is easy when handled appropriately. Your institutional policy will dictate if you are able to provide consulting services to industry. If you are able to consult, you must have a consulting agreement that is specific to your consulting task. You and the sponsor are both required to sign this agreement. All consulting agreements need to be approved by the compliance officer at your institution. Your consulting task should be clearly defined; this definition should include but is not limited to the specific task, time involved for the task, time that the consulting agreement is valid, and a compensation schedule. As mentioned earlier, you may have to remove yourself as an investigator in a clinical trial based on any compensation from consulting work. Each institution defines conflict differently, and you must disclose your consulting compensation honestly so that the outcome of a study is not compromised.

CONCLUSION

The physician-industry relationship is a two-way street that needs to be carefully handled. This relationship allows for the continued improvement and advancement in technology to help with patient care. It is important to handle your financial involvement carefully. Your honest disclosure of your role as a clinical trial investigator, educational grant writer, and consultant is imperative to the success of your career and your division.

Ross Milner, MD, is Associate Professor of Surgery; Chief, Division of Vascular Surgery and Endovascular Therapy; and Vice Chair, Clinical Research in the Department of Surgery, Stritch School of Medicine at Loyola University in Chicago. Dr. Milner serves as a clinical trial investigator for Gore & Associates, CardioMems, Bard, Cordis, and LeMaitre Vascular. He consults for Gore & Associates, Medtronic, and Bard. He also has ownership interest in CardioMems. Dr. Milner may be reached at (708) 327-3431; rmilner@lumc.edu.