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Building IR research 

07-06-2022 16:45

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Hope Racine, SIR TODAY 2022 | Thursday, July 14

A pervading theme heard throughout SIR 2022 was the importance of strong IR mentorship—a theme that was echoed repeatedly during the “Building IR research: Critical elements for success” session.

The session introduced attendees to the key elements needed to begin and establish successful research, from mentorship to funding to the finer points of paper writing. But the main takeaway was that any successful clinician scientist needs a strong community and mentor.

“Mentoring isn’t training, idle chitchat or socializing,” said Erik N.K. Cressman, MD, PhD, FSIR. “A mentor is someone who you can draw wisdom from and respect and who will help you shape your path.”

In his presentation, Dr. Cressman highlighted the key traits to look for in a mentor, such as whether they can dedicate time and interest in you, whether they’re experienced, and whether they’ve been successful in the path you wish to pursue. But you need to know what you want to do first, he said. Define your career goals, and then find someone who can help you achieve them.

“Mentorship is dynamic,” he said. “People change, situations change, and it’s completely fine to reassess your mentors on a regular basis.” But it’s helpful to make sure your goals align with the mentor’s qualifications and to be proactive in identifying new mentors. Keeping a log or journal of each relationship could also be helpful, especially if you plan to be a mentor yourself.

These support networks are crucial, especially for those looking to break into research, according to Julius Chapiro, MD, PhD, who presented on the challenges and opportunities involved in building an IR lab.

Before pursuing research, however, Dr. Chapiro advised thinking through why you wish to establish a research lab.

“Will research add value to your overall career? Are you doing this for love of research, or as a CV booster?” he asked. “You need to have the love of research, because you will be doing all the heavy lifting.”

A successful lab requires funding, support and collaborators, he said, as well as a motivated principal investigator. “This will become your primary professional identity,” he said. “You will take on intellectual leadership and an administrative role, and you will also define the research direction.”

In this role, he said, you will be responsible for funding, space, mentorship and sponsorship, and assume responsibility for the integrity of the research. This means having good time management and stepping into a mentor role yourself, especially for your students and postdoctorates, who Dr. Chapiro believes can be the most important team members.

Whether your collaborators are academic or industry, Dr. Chapiro suggests seeking partners outside your own specialty to help identify gaps in your knowledge and skills. And once you have those collaborators, then secure shared funding, share your unpublished data and publish together with shared authorship.

“Share generously,” he said. “And seek out senior collaborators who may help you overcome a lack of reputation; it’s easier to make concessions if you are prolific.”

But more than collaborators, institutional support can make or break a lab, Dr. Chapiro said. “You cannot build a lab without support, so you have to earn the trust of leadership and show your value.”

And be prepared to deal with every aspect, from funding to finding space. “Building a lab is an entrepreneurial task,” Dr. Chapiro said. “You need to have a business mentality.”

This means taking advantage of industry, society and foundational support and resources, and finding a niche to build your research topic around. “Define a problem and see if it’s worth solving,” he advised. “Don’t create solutions without a problem. Start with simple issues and maintain focus at all cost.” And above all, he says, be consistent with your research output.

Consistent quality and original research are crucial to securing funding in an increasingly difficult environment. That’s why researchers must be able to articulate the value of their research, according to Mitchell Schnall, MD, PhD.

“Research programs, at their core, cost money,” he said. “What is the value from an institution’s perspective?”

Quality research can improve a department’s reputation—which Dr. Schnall says is a department’s most important asset. A good reputation can help department heads recruit top faculty and trainees, establish a culture of innovation, meet the greater institutional mission and create a halo effect.

A reputation of compelling research and data lifts community reputation, Dr. Schnall said. “And no community values evidence like the oncology community.”

According to Dr. Schnall, IR won’t be recognized as the fourth pillar of oncology without robust trials and clinical research. IRs have unique skillsets that enable all kinds of research, from labs and animal trials to translating new methods in clinic, to trials comparing methods and devices.

IRs, in effect, should become clinician scientists, Dr. Schnall said. “But it’s hard.”

He acknowledged that clinical demands have become more and more difficult to manage, and the increasing sophistication of IR practice, along with the regulatory requirements of research, puts pressure on finding time to conduct research.

“That’s why being a researcher has to be an intentional act,” he said. “It’s not something that just happens.”

This is why training programs, investment, and effective recruitment is crucial, he said, a sentiment echoed by Susan Shamimi-Noori, MD, FSIR, IR residency program director at the University of Pennsylvania.

“There is a huge need for clinician scientists,” she said. “How do we bring them in? We catch them early and help them throughout their learning process.”

She presented the approach utilized at the University of Pennsylvania, which has a multipronged approach to creating and maintaining scientific talent.

“We start with predoctoral exposure,” she said, which can include a 1-year research training program during medical school, an IR-focused summer research program or postdoctoral training.

“Surgery has done this for decades,” she said, pointing to a paper from Washington University that indicated that the majority of residents who had research time built into their education continued to stay involved in research.

“The challenge, of course, is funding,” she said, suggesting that programs look to federal funding, as well as private organizations and foundations, societies, and institutional fundings.

Once funding is achieved, she recommends a structured curriculum with a focus on research training. This structured training program needs administrative support such as program directors, administrative assistants, faculty mentors and an advisory committee. She also recommends placing the dedicated research year mid-training—that way residents get exposure to clinical IR practice facilitating the formulation of clinically relevant projects in which they are interested. In these early years of training, residents spend time with potential research mentors and develop a project plan prior to starting the research year. During the research year, they continue to have exposure to clinical IR including attending clinical educational conferences and IR continuity clinic. After their research year, during the last years of clinical training, residents continue work on their project, finishing up loose ends, presenting at conferences and preparing publications. In addition, the institution should support the residents during the last years of training in order to ease the transition to a faculty position as their research endeavors continue.

“You want to develop these researchers and keep them in your own pipeline,” she said. “And after they become faculty, keep supporting them. Protect their research time, help mentor them, and encourage them to continue their coursework.”

This kind of support is critical not just to training scientists, but for pursuing the science as well.

“You cannot do this alone,” said Michael C. Soulen, MD, FSIR, during his presentation on the fundamentals of IR clinical trial design. Though the beginning aspects are templatized—Dr. Soulen recommends using standard NIH templates for clinical trial protocols and taking the RSNA clinical trials methodology workshop—protocol has to be developed with collaborators, mentors, statisticians and regulatory staff.

For a successful trial, Dr. Soulen said, you will need a big team and a lot of money. “You can’t be cheap,” he said. “If you cut corners, you will get in trouble from a regulatory standpoint.” He broke down his suggestions for budgeting, such as assuming $30k per subject and having 25% of the total budget up front for startup costs.

He also provided guidance on determining the primary objective and outcome measures. “Craft a single sentence stating the question you are trying to answer,” he advised. “Why are you doing this trial?” Then state the outcome measure you will use to answer your question.

“The entire trial scope and budget hangs on these two sentences,” he said.

Objectives and endpoints can also be a stumbling point, he said, noting that many pitfalls happen once the trial starts going if windows aren’t left for all events. “If something is supposed to happen in 30 days, make the window plus or minus a week.”

Then, once you get to the statistics portion, Dr. Soulen says to stop. “Just give it to your statistician.”

He advised attendees to talk within their team about how goals can translate to outcomes—curing the disease state can be survival, but so can prevention. And survival is what most patients care about in oncology trials, he says.

Affecting survival is the gold standard for Phase III clinical trials, Dr. Soulen said, adding that the FDA requires overall survival as an endpoint. Identifying survival takes a long time, however, and requires large sample sizes and larger budgets.

“You have to define what survival is,” Dr. Soulen said, explaining the differences between overall survival, disease-free survival and cancer specific survival, and which outcome is appropriate for various disease states and stages. And you must define how you will measure survival up front—be it overall survival, the time to progression, or whether you will focus on time-based outcomes, such as in systemic therapy trials.

However, interventional oncology therapies may be staged or repeatable, Dr. Soulen said, discussing trial design for staged therapies by looking at the structure of existing trials, such as the EPOCH trial.

“You may want to move on to surrogate measures of survival that don’t require overall survival,” he said, adding that this can be an endpoint for Phase II trials, which are faster and cheaper.

But once the trial is completed, the research isn’t done. IRs still need to publish their findings—which, as Alda Tam, MD, FSIR, stated, is one of the most impactful aspects of the research process.

“The underlying issue is the need to be able to write and express yourself successfully,” she said. “It’s the bridge between your science and your audience. And it’s hard.”

Writing is a skill like any other that can be learned, she said, and there are ways to succeed.

“Listen to what your journals are telling you,” she said, pointing toward robust style guides and writing courses like the ones offered by the Journal of Interventional Radiology (JVIR). “And practice, practice, practice. Rewrite and rewrite.”

And don’t be afraid to ask for help, she added, suggesting several papers and resources that provide tips for paper writing. Dr. Tam shared some of her own system, such as writing the paper out of order. “Start with the materials and methods, because those are very standardized,” she said. “And then you will already have words on the page.”

Then, once you have a manuscript, Dr. Tam reiterated the theme of the session. “Go get feedback. Take it to a mentor or colleague.”

 

Missed this session? You can watch it anytime online via SIR Now.


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