Doing it All Under One Roof: Conducting Clinical Research in the Private Practice Setting - A Q&A with Kathleen Gibson, MD

When Kathy Gibson was in training at the University of Washington, academics was considered the pinnacle to which one could professionally aspire. When she broke it to her mentor that she would not be pursuing a career in academics, he thought it was a mistake. “I’ll give you five years,” he said, “Then you’ll become bored and want to be back doing research.” He was half right.

VM: What made you initially decide to go into private practice?

KG: I finished my Vascular Surgery Fellowship in 2001, and I decided to become a private practice vascular surgeon after having my first child during my research/lab year. Although I had discussed my career trajectory many times with my mentor and had really enjoyed my clinical research projects, from my perspective, clinical research was not conducted in a private practice setting.

I joined a great partner in a two-person private practice vascular surgery group that soon grew to three, and then finally to five partners. I remained very involved in clinical meetings both regionally and nationally, and was very satisfied with my practice life.

VM: So, what gave you the inspiration to start conducting research within the practice setting?

KG: Our group started performing endovenous laser ablations in 2004, and after becoming facile with great saphenous (GSV) ablations, we began performing small saphenous ablations (SSV). One of our major insurance carriers denied ablation of the SSV, claiming it was “experimental” and that there was no data to support it. Since our group did many of these procedures, I felt that we could supply the data to support laser ablation of the SSV.

We collected data on 187 patients with SSV ablation and presented the data at the Western Vascular Society Annual meeting in 2005, and subsequently published the data in the Journal of Vascular Surgery. After our work was published, the insurer that had previously denied coverage for ablation of the SSV now agreed to cover the procedure.

My first foray into clinical research while in private practice was rewarding for me personally, as well as for our practice. Since then we have partnered with industry both independently and in conjunction with our local hospital on a number of clinical trials. We have also conducted independent clinical research on questions that we have been curious to explore. Our practice has participated in clinical trials involving varicose vein therapy, DVT treatment, wound care, intra-operative hemostatic agents and salvage of dialysis access conduits.

Clinical research is now an integral part of what I do on a weekly basis. Integrating my interest in clinical research with my private practice has been intellectually stimulating and has been rewarding on many levels for my partners, my patients, and me. While my career is proof that research need not be relegated to the realm of academicians alone, there can be logistical challenges to overcome and efficient time management becomes crucial.

VM: What are the major considerations one should factor into deciding whether to conduct research within a practice setting?

KG: There are many reasons why a private practice physician would want to integrate research into their practice, but the demands of research should not be underestimated. For physicians already busy with the stresses of patient care, managing personnel and watching the bottom line of their business, clinical research adds another layer of responsibility and occupies precious hours.

The paperwork that needs to be completed in an excruciatingly thorough manner can seem endless, the protocols that need to be followed to a “T” may seem inane and there may be many hours of uncompensated time. For me and other private practice physicians who make time for research in their practices, the rewards outweigh the difficulties.

Clinical research can be intellectually stimulating and certainly adds variety to the day-to-day tasks of patient care. The opportunity to travel to meetings and present one’s work and to see that work published is very gratifying. Making contributions to the development of new therapies or to the understanding of disease processes helps fulfill the intellectual curiosity that most of us in the medical field innately possess.

Involvement in clinical research sometimes allows you to offer your patients treatments that would otherwise not be yet available to them, and give you early access to emerging technology or new medical therapies.

VM: What benefits has your practice gleaned from adding on research?

KG: Clinical trials can be practice-builders in two ways: bringing new patients to your practice and increasing community awareness of your practice. In many cases, industry-sponsored clinical trials have marketing budgets to let referring physicians and patients know about the trial, and such marketing may be a benefit, as well.

Typically, when partnering with industry, your practice will be one of a number of clinical sites involved in the trial. This is especially true in drug or device trials. Your time and the practice resources consumed will be reimbursed according to whatever contract you have with the trial sponsor.

Most of the research our group has conducted has been in partnership with industry; however, we have also analyzed data collected from our own practice to answer clinical questions. While your time and efforts conducting your own non-industry supported research will not be reimbursed unless you have some sort of grant, this sort of activity really becomes your own “baby” and can be the most gratifying!

VM: How does one get started?

KG: The simplest way to get started in clinical research is to look to your own practice and to think of a clinical question that you would like to answer based on data that you may already have at your fingertips. This could be as simple as analyzing data on outcomes that you may already be collecting on your patients. Once your analysis is complete, present your findings at a local, regional or national meeting or even write a paper.

If you are planning an independent clinical study outside of what you are already doing in your own practice, you will need to create a study protocol and a consent form/process for your patients. You will also need to obtain Institutional Review Board (IRB) approval. If your hospital does not have its own IRB, there are a number of central IRBs that can be used.

If you decide that clinical research is rewarding and a good fit for your practice, you may want to partner with industry and become involved in clinical trial. A good place to look for clinical trials is here. This is a searchable government-sponsored website that lists registered trails throughout the world, outlines the purpose of the trial,lists the exclusion and inclusion criteria for the trial and contact information for the sponsor. There are a number of commercial websites that (usually for an annual fee) will list details of your practice on their site as an investigator database for industry searches. Finally, your local hospital may also have resources and relationships with industry or be conducting independent clinical trials and might welcome your participation.

VM: What is the best way to get involved in industry research?

KG: Industry sponsored trials relieve you of the task of having to come up with a study design or a clinical protocol. However, you must carefully consider whether your practice has the resources and proper patient population to responsibly participate in the clinical trial. Unlike independent research, where you essentially run the show, you are often strictly held to deadlines to complete paperwork and reports necessary for the study. Make sure you have administrative support and “buy in” from your staff before embarking on any clinical trial. If the trial is something that you are excited about, be sure to share that with your staff so that they can share your enthusiasm and help your site to be successful.

Once you have been identified as a potential trial site, the sponsor will ask you to sign a disclosure agreement before they will share with you any confidential aspects of the trial. Following the disclosure agreement, you will likely fill out a site feasibility questionnaire, where you give the sponsor information about the makeup of your patient population. If the sponsor thinks your practice looks like a good fit for the study, you will be sent a full study protocol as well as an investigator’s brochure (a document which fully details all the clinical and nonclinical data known about an investigational drug or device).

Now it is your turn to see if you think the study is a good fit for your practice. This is the time to be realistic about the time and resources you can commit to the study. Before committing to a clinical trial, it is necessary that you have a genuine interest in the outcome of the trial, and that you feel comfortable having your patients participate. You need to make sure that you have an appropriate patient population and that you have staff that can support you for the trial.

KG: If you decide to proceed, you will almost always have a visit to your site from the sponsor so that they can decide whether to select you as a site for their trial. Following site selection, you will negotiate a contract with the sponsor and a budget for your reimbursement. With the sponsor’s help, IRB approval will be obtained prior to start up at your site. With all the necessary contracts signed, you will have a site initiation visit from the sponsor prior to treating your first patient.

Over the course of the trial, you will have periodic visits from a site monitor. This individual works on behalf of the sponsor to ensure that the study is being correctly conducted. While you are getting familiar with your first clinical trial, the site monitor can be an invaluable resource to help you learn the ins and outs of conducting a clinical trial. Once the trial is completed, you will have a closeout visit from your site monitor to make sure that all the necessary paperwork is signed off and accurate before analysis of the collected data.

While there are many more steps along the way to conduct a clinical trial with industry compared to conducting your own trial, this partnership can be very rewarding. It allows even small private practice groups the ability to be involved in cutting-edge technologies and novel therapies. As government grants and research funding become scarce, there will be an increasing role for private practice physicians to participate in clinical research - both in outcomes studies and in the development of new therapies. Clinical research is no longer clearly relegated to the halls of academia.

For me, it offers both intellectual stimulation and a sense of pride in contributing to the advancement of patient care. I consider my involvement in clinical research to be both a privilege and a great opportunity.