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JOP: First things first—how did you get interested in oncology?
PJS: I got interested because half of my father's family of 13 died of cancer. Once I was actually asked why I would go into a field where everyone dies! But the fact of the matter is, everyone you see needs you, and you can help all of them in one way or another. Some you can cure, and others you can prolong their lives. Sometimes all you can do is provide comfort measures for the dying, but in every case, you're helping. I found that very appealing. I also found the science of oncology extremely appealing.
JOP: Where did you study?
PJS: I attended medical school at Michigan State University's College of Human Medicine [East Lansing, Michigan], and did residency right here at St. Joseph's. I had a fellowship in medical oncology at the Mayo Clinic [Rochester, Minnesota], and returned after that, and have practiced here ever since.
JOP: How would you describe your practice?
PJS: I manage a private practice of six full-time medical oncologists. A new associate was recently hired, and an eighth will be added in 2007. The practice also employs a physician assistant, a former patient with Hodgkin's disease. She now has four children and works half-time. We also employ a clinical nurse specialist.The hospital is the main site of practice, although we maintain a satellite office in Brighton, Michigan, where we have almost completed a $13 million free-standing cancer center which will include radiation and medical oncology.
JOP: That's a significant capital allocation. Do you use strategic planning to guide decisions like that?
PJS: The hospital's oncology program has a 5-year strategic plan which is closely integrated with the practice's plan. The hospital-based program is multidisciplinary and of course includes radiation, medical and surgical oncology, imaging, and all that. We collaborate closely. Chemotherapy, for example, is administered by the practice, but delivered in a hospital-based community infusion center. Many practices have emulated this arrangement.As far as capital allocations, the practice makes decisions about its own allocations, and when there is a major allocation for the hospital program, it is done in conjunction with the appropriate department. For example, the hospital recently purchased a da Vinci robot [Intuitive Surgical, Sunnyvale, California] for surgery, and is in the process of acquiring a CyberKnife [Accuracy, Inc., Sunnyvale]. The hospital has also recruited various specialists including a thoracic oncology surgeon and a gastroenterologist, which complement the specialists in our practice.
JOP: When you hire a new associate, what do you look for?
PJS: We look for personable people coming out of good programs, people who have excellent clinical skills and bedside manner. Also, [people] who can integrate nicely with us, because we are a consensus practice. We make decisions as a group, and each pull our own weight. So, we want people who aren't afraid to work, and who will contribute to the practice in some way, whether that's bringing in administrative skills, or computer skills, or an interest in a particular area. We want people trained in both hematology and oncology, to cover the multitude of things we see.As medical director, I also want people who can move the program forward. Our most recently hired partner had an interest in head and neck cancer, and he's now running that program. Another was interested in quality, an area we continue to emphasize. I always look for people with a strong interest in research, because our culture is very much academic. I don't want someone who's just going to see patients.
JOP: Is conflict resolution ever an issue?
PJS: The people we hire are interviewed by everybody, and we get a sense of whether they're going to fit in. We don't want people who are just in it for the money.The Professional Corporation [PC] meets monthly, under the direction of the managing partner, and at those meetings we work through any issues. Once in a while, the issues will pile up, and we'll have a retreat. But we always work towards consensus, and we've never had to take a vote.
JOP: You organized a large statewide community clinical oncology program [CCOP] that accrues well to cooperative group clinical trials. How did it get started, how did you make it grow, and how do you keep it going?
PJS: The Michigan Cancer Research Consortium [MCRC] was started in 1993, and is holder of the CCOP grant. There were four of us back then, and I became the medical director. I thought that, given the quality of people we had on board, and the number of patients we saw at St. Joseph Mercy Hospital, we could become our own CCOP. So we applied for a CCOP grant, and got accepted our first year. We quickly understood that the grant was all about accrual and numbers, and since there were efficiencies to being larger, we expanded to other hospitals in the southeast Michigan area. The MCRC now consists of nine hospitals in southeast and central Michigan, and has more than 10,000 patients in the collective tumor registry. All nine hospitals have a central oncology IRB [institutional review board] for the CCOP, and single-signature contracting, so that pharmaceutical companies [who sponsor studies] can be contracted with one signature. Needless to say, this is very appealing to them: a large number of patients, very experienced investigators and staff, and an operations office that is second to none. Pharmaceutical companies now preferentially seek us out, and more than one have wanted to use us as a primary site for innovative phase II work.Meantime, we put over 600 patients on clinical trials each year, exclusive of the pharmaceutical trials, and that number keeps growing. We do both prevention and treatment.
JOP: What benefit do the hospitals receive for participating in and providing support to the program?
PJS: The patients win by getting access to the latest treatments, whether in National Cancer Institute– or pharmaceutical-sponsored trials. For example, at one point we were the only site in Michigan to get Erbitux [cetuximab; ImClone Systems, Inc., New York, New York] and Avastin [bevacizumab; Genentech, South San Francisco, California] for colon cancer. Access to drugs is a huge issue for patients and of course for doctors too.Doctors get to be part of research, which adds a dimension to their professional life. They become part of the whole mechanism by which drugs get approved, and it's exciting to be involved at the ground level.The hospitals get a cutting-edge research program. In my mind, you can't call yourself a cancer program unless you're participating in research. So for the hospitals, there's a certain status. In fact the American College of Surgeons now requires that hospitals of a certain size have to take part in clinical trials. Besides, patients more and more are on the Internet, and know where trials are being done. Especially here in Ann Arbor, which is a university town. They come in and say, “I want to participate in this trial.”
JOP: Did you have to overcome any problems in growing the clinical trials organization?
PJS: We had to be patient! It has been a labor of love. Anybody who thinks they're going to make money on research is crazy, because it's an expenditure of staff and physician time, and you will never get adequately reimbursed.First, we had to go into hospitals and find the principal investigators who were interested in doing clinical trials, and help their hospitals understand the importance of these trials. That was a huge barrier.Trying to get a central IRB together was also huge. We were working with the chairs of all these independent IRBs, and getting them to give up autonomy was a major problem. We actually found that the hospitals were quite willing when they saw how much time and money they could save by doing this centrally, rather than individually. Getting the contractual forms for the MCRC wasn't easy. You can imagine, trying to get nine hospitals to sign off on the same agreement?Each hospital now has one or more members on the central IRB, and the CCOP is run very democratically. Governing board meetings occur three to four times a year, and involve principal investigators and administrative staffs from all the hospitals involved. Doctors and hospitals have to work very closely to make this work, and all major decisions are approved at these meetings. Daily operations of the CCOP and IRB are handled by Beth LaVasseur at the operations office at St. Joseph Mercy Hospital.
JOP: It obviously runs well. Ms. LaVasseur, what's your secret?
BL: It's important to get each hospital's administration to buy in, and also to help the hospitals build the infrastructure they need, so they will be able to support the doctors who put patients on trials. Physicians who come from academic settings understand the time involved, but those coming from private practice may not. So we help the hospitals learn a culture of supporting the private practice physician, so they will be able to take part in research. We spend a lot of time helping develop programs that facilitate smaller hospitals and private practices put a good number of patients on trials and sustain high quality.Remember, this has been in development for 10 years. It takes hospitals a good 3 to 5 years before to become active accruers, and if there's a change in staff, we almost have to start over. We're learning as we go, how to create strategies to maintain an infrastructure at each hospital. We do a lot of on-site visits, and communicate constantly. We talk to almost every hospital at least once a day. We also pass through grant funds to assist with FTE [full-time equivalent] support.
JOP: Sounds like it takes a lot of patience. Dr. Stella, your group is in the back yard of a major cancer center. How do you interact? And do you find yourself competing for patients or resources?
PJS: Actually we're between two comprehensive cancer centers: the University of Michigan in Ann Arbor, and Karmanos in Detroit. We have very good collaborative relationships with both. I'm on staff at the university, and we work with Karmanos on phase I studies. Also, everybody is busy in oncology, so we're not fighting for patients. And our program has thrived and grown because almost 90% of our patients are treated in the community.The challenge going forward will be to build on the relationship between the academic centers and the community, to take advantage of bench research and programs being developed at the academic centers, and meld it with the clinical research that can be done in the community, where the patients are.
Nine regional hospitals work cooperatively as the Michigan Cancer Research Consortium (MCRC), and bring clinical trials to 10,000 patients statewide. Philip J. Stella, MD, was the architect of this consortium and remains its principal investigator. He is also medical director of the cancer care program of St. Joseph Mercy Hospital in Ann Arbor, and a medical oncologist in private practice. The Journal of Oncology Practice recently spoke with Dr. Stella and MCRC Administrator Beth LaVasseur about the history and present challenges of managing such diverse organizations.