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Beyond the basics

Daniel Mulrooney, M.D., M.S., examines two-time cancer survivor Nichole Wilson. Mulrooney is studying the “late effects” of chemotherapy and radiation therapy on people who have been treated for cancer as children.

Innovative program helps junior faculty break into the world of clinical research

For Daniel Mulrooney, M.D., M.S., assistant professor of pediatric oncology, it’s the classic Catch-22. To do biomedical research, you need time, funding, and know-how. To get time, funding, and know-how… you need research experience.

Mulrooney spends much of his time at the University of Minnesota Children’s Hospital, Fairview, caring for young patients who have cancer. He’s also very interested in studying the “late effects” —those that show up after years or even decades—of chemotherapy and radiation therapy on children, and learning what he and others can do to minimize them. But when he applied for federal funding to conduct research on the topic, Mulrooney discovered he lacked the track record needed to land a major grant.

Then he heard about the University of Minnesota’s Career Advancement Program for Clinical Research Scholars (CAPS). Part of a nationwide national Institutes of Health (NIH) initiative, CAPS was established in 2005 to help early-career faculty in the health sciences break into clinical research. Mulrooney applied to the University’s program and was accepted as one of seven inaugural scholars. Under the guidance of a multidisciplinary team of mentors, he has since begun recruiting survivors of Hodgkin’s lymphoma for a preliminary study of biomarkers of inflammation and vascular injury.

“I think CAPS is a terrific program,” he says. “This is just what a junior faculty member needs to navigate the waters and learn what you otherwise wouldn’t know how to achieve.”

Boosting clinical research

Clinical research has faced tough times in recent years. Traditionally, new treatments and cures emerge from a pipeline that extends from basic science (studying how living systems work) to translational research (studying how to apply new knowledge to human health) to clinical trials and, ultimately, patient care. Basic scientists have been making great strides in understanding how molecules, cells, tissues, and organs function.

But the translation of this new knowledge to new approaches to prevention, care, and cure has lagged. Although there are many reasons for this, two critically important ones are more competition for less federal money and the pressure on physician-researchers to produce revenue through patient care.

“Clinicians interested in doing research find themselves taking academic positions, and suddenly all of their time is taken up by clinical duties, system demands, and the need to generate income,” says CAPS program director Russell Luepker, M.D., M.S. Without some type of support that allows them to reduce their clinical hours, Luepker says, even the most dedicated find it difficult to get the research experience they need to successfully compete for major grants.

Kamakshi Lakshminarayan, M.D., Ph.D., listens to advice from Russell Luepker, M.D., M.S., one of her mentors in the CAPS program. She hopes her research will lead to better outcomes for stroke patients.

In 2003, the federal government began funding a massive initiative known as the NIH Roadmap, which aims to speed the delivery of findings from basic science research to the clinical scientists who can apply them to patient care. Part of that initiative involved awarding grants to 12 academic health centers around the country to develop programs to boost clinical research by providing support and mentorship for early-career medical professionals. Luepker, a professor of epidemiology, led the effort to get the University of Minnesota on board and ended up with $13.8 million from the NIH to start CAPS.

James Neaton, Ph.D., M.S., professor of biostatistics, and Elizabeth Seaquist, M.D., professor of medicine, are associate program directors. “The program greatly enhances the training opportunities for clinical research,” Neaton says.

Seaquist agrees, and points out that CAPS is good not only for the University but for the rest of the world as well.

“It’s so critical that we have health professionals who will apply their clinical skills to research questions,” she says. “We need these people if we are going to solve the big problems.”

Buying time

CAPS offers three key types of support to clinical faculty launching their research careers in medicine, nursing, pharmacy, dentistry, and public health.

The first is funding. Scholars receive up to $25,000 in research support annually as well as travel money, graduate tuition, and textbook reimbursement. Even more valuable, CAPS supplies the dollars needed to cover 75 percent of its scholars’ salaries for the three to five years it takes them to develop a research program solid enough to successfully compete for NIH grants and other support. That buys them “protected time” —a portion of their work week in which they are committed to doing research.

Through such opportunities, the first CAPS scholars have been able to initiate research programs related to their professional areas of interest, including understanding schizophrenia, improving cancer treatment, and investigating novel applications for antiviral drugs.

“Each [scholar] is doing a different project with a different team in a different department, yet they’re all doing amazing things,” says CAPS mentoring and evaluation director Carole Bland, Ph.D., assistant dean for faculty development and professor of Family Medicine and Community Health in the Medical School.

Kamakshi Lakshminarayan, M.D., Ph.D., an assistant professor of neurology, is using her protected time and tuition benefits to pursue a master’s degree in health services research and policy.

“My professional goal is to advance and improve the clinical care of stroke patients, both at the individual and the population levels,” she says, adding that CAPS has given her the opportunity to work toward that goal.

Learning the ropes

Besides financial support, CAPS offers faculty opportunities for formal and informal guidance as they learn the basics of biomedical inquiry.

In the past it was possible to learn the ropes by spending time in others’ labs—what Seaquist calls the “follow along and you’ll figure this out” approach. But today’s clinical science demands intensive training in everything from using sophisticated analytical technology to dealing with sensitive legal issues.

CAPS scholars learn the ropes by taking classes in clinical research management and career development and by participating in regional and national meetings that address issues they face as new investigators. The University’s Office of Clinical Research (OCR), which works closely with CAPS, offers biweekly seminars on a variety of topics and periodically brings in distinguished visiting scholars who provide valuable insights and advice.

“How to write a grant, how to do a scientific presentation, how to work with industry… It’s been so diverse, things I never would have thought of,” Mulrooney says.

CAPS scholars can also sign up for one-on-one help with biostatistics, budgeting, pharmacology, legal and regulatory matters, scientific writing, Institutional Review Board issues, and other dimensions of research they might be facing for the first time.

“It’s all about providing a support structure that allows scholars to succeed,” says OCR director Jasjit S. Ahluwalia, M.D., M.P.H., M.S.. “CAPS gives them the tools to get the work done.”

Multidisciplinary mentorship

Multidisciplinary mentorship is the third component of CAPS’ three-pronged approach. Each CAPS scholar gathers a mentoring team of at least three people—two in fields directly related to his or her subject of study, and the third a biostatistician—who then work together to help guide the scholar.

“Mentoring is a significant part of this program,” says Bland. “We want to produce clinical scholars who are comfortable and competent in addressing important clinical questions through an interdisciplinary framework.”

Professor and interim head of pediatrics Joseph Neglia, M.D., M.P.H., who is Mulrooney’s primary mentor, appreciates the extensive mentoring CAPS promotes. “One of the roles of more senior faculty is the mentoring and development of more junior faculty—we’re going to do that no matter what,” Neglia says. “But the CAPS program has allowed some additional resources for that.”

CAPS scholar Lisa Chow, M.D., aims to find better ways of preventing and treating type 2 diabetes.

CAPS scholar Lisa Chow, M.D., an assistant professor of medicine, is studying the link between lipid metabolism in skeletal muscle and insulin resistance. Her goal is to find better ways of preventing and treating type 2 diabetes. Chow says mentorship is critical for young faculty embarking on a research career.

“When you’re starting out as a new and young investigator, you might not know all the subtleties,” she says. “The mentor team has been essential in helping me define the research questions and identify available resources.”

Its multidisciplinary emphasis sets CAPS apart from other, more traditional mentorship programs. Mulrooney’s team, for instance, includes Neglia, biostatistician Neaton, and Robert Hebbel, M.D., Regents Professor and vice chair for research in the Department of Medicine.

“I’m looking at adult survivors of childhood cancer, so it’s particularly helpful to have one foot in pediatrics and one in adult medicine,” Mulrooney explains.

Medical School Dean Deborah Powell, M.D., says she’s happy to see senior faculty playing this important role.

“Clinical research reflects the passion of our physicians and scientists to improve care for patients,” Powell says. “Our Medical School has excellent, seasoned clinical researchers who are exemplars of lifelong learning. I am excited that they have been recruited as mentors to encourage and educate the next generation of young faculty who wish to pursue clinical research.”

CAPS scholars undergo formal assessments every six months by the program’s Multidisciplinary Advisory Committee, whose 20 members, drawn from close to a dozen different fields, review the scholars’ work and feedback from mentors, and then offer advice on ways to improve the experience. “They take a higher, objective view to see that you’re on track,” says Lakshminarayan.

Moving on

The second round of CAPS recruitment, completed last February, brought in another eight scholars to join the seven already on board. Subjects of inquiry include jaw-muscle pain, multiple sclerosis, prenatal alcohol exposure, and the impact of aerobic exercise on dementia.

A third group of candidates will be reviewed this fall, and Luepker anticipates having a total of about 20 active scholars three years from now. But as important as moving faculty into the program, he says, is moving them out again. The ultimate goal is a cadre of well-trained clinical researchers with a track record and support system that facilitates access to major research funding.

“Our goal is to get people moving on to regular NIH grants,” Luepker says.

Funding for the CAPS program is in place through 2010. Ahluwalia is currently leading a major effort to join a new, multifaceted NIH program supporting and stimulating clinical research called the Clinical and Translational Science Awards. If he is successful, the CAPS program will continue to nurture future scholars as part of the larger grant.

Meanwhile, Luepker is delighted with the progress so far. If CAPS scholars are any indication, he says, the future for clinical research nationwide, and particularly at the University of Minnesota, is brighter than ever.

“I’m really impressed,” Luepker says. “[These scholars] have a lot of enthusiasm and energy. I think they’re going to make us proud through what they accomplish.” 

By Mary Hoff

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