All Roads Lead to Vail: Preparing for a Career in Clinical Research

Clinical investigation is a vital part of an academic career in medical oncology. Gaining experience in clinical investigation, however, requires enthusiasm, opportunism, and a little bit of luck. Residency and fellowship can teach you about the clinical care of patients, but it takes an extra bit of eff ort and opportunity to learn how to be a clinical investigator.

The annual Methods in Clinical Cancer Research Workshop, sponsored by the American Association for Cancer Research/American Society of Clinical Oncology (AACR/ASCO) in Vail, Colorado, provides a unique opportunity to meet and work with expert investigators and to network with other fellows or new faculty who are interested in developing a career that includes clinical research. The workshop helps you to hone your research skills, understand trial design, and read and comprehend the literature.

This article will outline some of the steps required in the process of getting accepted to the workshop and developing an excellent protocol. It begins with mentorship, continues through the application/preparation stages, and even extends to after the meeting.

Generating an Idea

Coming up with an original idea that merits further studyis intellectually the most difficult part of the process. Having good mentorship is critical to getting an idea started, whether it is a mentor from prior research experience in medical school, your residency, or your fellowship. Having a point person—such as your program director, a research mentor, or someone with whom you have already collaborated—review your idea is absolutely essential in the early stages of developing a protocol.

Before applying to the workshop, ask your mentor to review your idea and determine whether it can be developed into a viable protocol. A good idea is simple, has a measurable end point, and asks a question that can be answered by a relatively straightforward design. Broad questions such as “Does agent X work in breast cancer?” are much too general. A focused way of formulating the question would be more like, “Does agent X, when given with standard neoadjuvant therapy in breast cancer, phosphorylate target Y in the tumor when the excised tissue is examined?”

Once you have developed an idea, start looking for funding mechanisms, whether it is an institutional grant, National Cancer Institute (NCI) grant, ASCO fellowship grant, or some other resource. In your application, you will need to demonstrate that the trial you are planning has a chance of reaching completion.

Applying to the Workshop

The application itself will test your ability to distill your idea into a concise application, and closely mirrors the structure of an NCI-sponsored grant application. Applications are due in March and can be downloaded from www.vailworkshop.org. (Check the site for the actual deadline date.) The requirements are fairly straightforward. You will need to submit an online application form, a brief description of your trial, your CV, a statement explaining why you wish to participate in the workshop, and a letter of recommendation from your program supervisor or department head. If individuals from your institution have attended in the past, soliciting their feedback during this process would be very helpful. If they still have their proposal, it is worth a read to get an idea for the structure of the application.

As you write your application, ask yourself, “If this concept gets approved, could I accomplish this in the next couple of years?” You will be judged on your trial design, so keep it simple and straightforward and be sure your objectives are achievable. If you design a multi-institution trial that enrolls 3000 left-handed patients with atypical carcinoid, your application will probably be turned down because it is simply not feasible. A small, biomarker-driven, proof-of-principle, early-phase study is much more likely to be accepted.

The review of your application takes a couple of months. If you get accepted to the workshop, congratulations! If not, use the experience to make next year’s application better. (And do not lose heart: applicants are encouraged to reapply.)

You will have about 3 months to prepare for the workshop. Do not use the time to write the protocol; the whole point of the week in Vail is supposed to be for crafting the protocol itself. If you have a prewritten protocol, you will end up being disappointed, because what you thought was a perfectly elaborated idea will likely be radically changed. Instead, use the time to solidify your thinking and to learn everything you can about the disease you are studying, the treatment you are proposing, or the experiment you are conducting.

Attending the Workshop

If you planned on doing a lot of hiking, biking, canoeing, or sightseeing while in Colorado, you will be disappointed. Most of your time at the workshop will be spent indoors. Remember, Vail is at 8000 feet, so if you feel dyspneic, you are not alone. You will also be reminded to drink a lot of water.

The lectures are broad and not too in-depth, so they will be applicable to most attendees. Most of the lecture slides are available on a flash drive that you will receive when you arrive, so you will not have to scribble notes the whole time. Bring your own laptop. Although there is a computer lab, having your own hardware is helpful.

The essence of the workshop is in the small-group sessions. You will be asked to defend your idea to about 8 or 9 other workshop attendees, a statistician, 2 faculty members, and a patient advocate. Many times, the trial concept will be radically altered by the group or the faculty. Be willing to be flexible. This is the time where you will be sorely disappointed if you had a randomized phase II design already written and it gets critiqued into a single-arm phase I study.

If you need extra assistance, every faculty member has “office hours” for one-on-one time. Take advantage of the opportunity to meet opinion leaders and key members of the research community. Not only can they improve your protocol, they can help provide you with career advice or some direction on future trial concepts.

When you are not in lectures, small-group sessions, or office hours meetings, you will be writing. You will need to turn in a protocol development sheet (ie, a brief summary of the trial after its initial revision), a statistical design, rough draft, informed consent, and final copy. In total, it will end up being more than 50 pages of text. It seems like a lot, but the templates are incredibly helpful for keeping your protocol in proper order. By the time you complete the workshop, the document you produce will be nearly ready for a review committee back home.

Taking the Lessons Home

While the workshop cannot teach every nuance of clinical research in the span of a week, it will certainly illuminate some of the critical steps required for turning a hypothesis into a study with maximal potential for achieving its objectives. Applying the tools learned in terms of statistical methods, correlative end points, or useful biomarkers will help you in any future research endeavor. Spread the lessons around to your co-fellows and be a helpful reviewer of your colleagues’ ideas. Stay in touch. Your faculty members from Vail will want to hear how your protocol went and how your career is going. Their feedback can be helpful well beyond the week you spend in the mountains.

My time at the Methods in Clinical Cancer Research Workshop was one of the most challenging—but fun—experiences of my fellowship in oncology. I hope these refl ections will encourage you to submit your own application!

Sam J. Lubner, MD, is assistant professor at the University of Wisconsin Carbone Cancer Center in Madison.

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Oncology FellowsGenentech