Surgery News - February 2008 - (Page 13)

F E B R U A RY 2 0 0 8 • SURGERY NEWS NEWS FROM THE COLLEGE ACOSOG Shares Clinical Trial Funding Tips B Y D A V I D O TA , M . D . , F A C S , A N D H E I D I N E L S O N , M . D. , FA C S S urgeons have responded to previous articles from the American College of Surgeons Oncology Group (ACOSOG) urging greater participation in clinical trials. Patient enrollment into these trials has increased, and surgeons have also shown the capability to acquire the skills and methodology to conduct clinical trials ( J. Am. Coll. Surg. 2006; 203:269-76). There remain, however, questions about the financial management of clinical trials, and a short discourse on this subject is important as ACOSOG opens more trials for surgeons. The primary goal of a clinical trial financial plan is to generate sufficient revenue to cover costs so as to achieve budget neutrality. Although the National Institutes of Health/National Cancer Institute (NCI) is an attractive place to find trials, reimbursement for each patient enrolled may be $2,000 or less. ACOSOG sites have learned that the initial enthusiasm to enroll patients into trials was later tempered by the reality of covering the cost of monitoring patients and submitting long-term follow-up data. Cost analysis to conduct clinical oncology trials have been published elsewhere (C-Change: A Guid- ance Document for Implementing Effective Cancer Clinical Trials). The C-Change data show that the median cost for a phase III antihormonal therapy breast cancer trial is $3,700 per patient. ACOSOG has used these data to seek supplemental funding from industry sponsors. For example, ACOSOG has secured supplemental grants for Z1031to increase capitation to $3,494 per patient. As an NCI cooperative group, we collect the data and publish the results in partnership with NCI and industry sponsors. This public-private partnership is based on the philosophy that trials are supported by taxpayers and industry, who benefit considerably from the results of a trial. Not all NCI trials have such attractive capitation in order to maintain budget neutrality, and another approach is needed. Industry-sponsored trials are an alternative revenue source. Reimbursement is generally higher than for NCI trials and can be used to diversify a portfolio of clinical trials to keep a balanced budget. This approach is much like managing a practice-payor mix for health services. Many surgeons who have successful clinical trials programs have a mix of government- and industry-sponsored trials. Finding such industry-sponsored trials can be problematic, but ACOSOG is introducing industry sponsors to our surgeon network. ACOSOG surgeons are highly encouraged to enroll patients into NCI trials, but each site is allowed to determine how best to manage the revenue source. Another potential source of funding is a local underwriter, which can be either a local hospital or foundation. Obtaining such funding requires negotiation skills and navigating the competing interests in a locality. Occasionally, there are opportunities to enroll the same patient into two different trials. A good example is ACOSOG Z1041, a phase III trial exploring neoadjuvant chemotherapy for locally advanced breast cancer. The capitation is $2,000. ACOSOG is developing a sentinel node trial after neoadjuvant chemotherapy with a $2,000 capitation. When activated, it may be possible to enroll the same patient into both trials, if the patient consents, and this strategy reduces the cost of collecting data for two trials. Although ACOSOG offers practicing surgeons the chance to contribute to scientific discovery in its clinical trials, the group also understands that such enthusiasm requires a financial basis. You may know about other revenue sources, and we would greatly appreciate your ideas (send an e-mail to david.ota@duke.edu). Future articles will address multiyear budgeting and managing costs. ■ DR. OTA and DR. NELSON are ACOSOG co-chairs. Dr. Puder Wins 2007 Jacobson Award ark Puder, M.D., FACS, was selected as the third annual Joan L. and Julius H. Jacobson II Promising Investigator Award winner. He received a sculpture award at the Clinical Congress last October and was honored during a luncheon with Dr. and Mrs. Jacobson. Currently, Dr. Puder is associate professor of surgery at Harvard Medical School and assistant program director Mark Puder, M.D. (left) with ACS President of pediatric surgery at Chil- Gerald B. Healy, M.D., FACS, at the 2007 dren’s Hospital Boston. After Clinical Congress. receiving his medical degree from Vanderbilt University School of ment strategies. Research on the role Medicine in Nashville, Dr. Puder re- of the intravenous fat emulsion used ceived his initial postgraduate training in in parenteral nutrition led him to conpediatrics at Yale-New Haven Hospital clude that currently available fat emuland completed his residency at Beth Is- sions may contribute to the development of this condition. rael Deaconess Hospital in Boston. He conducted studies in a murine After his general surgery residency, model to determine if a different he completed a research fellowship source of fat may reverse or prevent program at the Dana-Farber Cancer this fatal complication. He and his colInstitute and a pediatric surgery fellowship at Children’s Hospital Boston. leagues found that fat emulsions derived from fish oils were effective in reHe earned a doctorate in virology/biochemistry at Harvard and versing PNALD and preventing its development. His findings were apwas conferred a K08 award from the plied to a 5-month-old patient with seNational Institute of Diabetes and Divere PNALD (and listed for a liver gestive and Kidney Diseases; his retransplant) within months of animal search receives funding from the U.S. experiments. Within 2 months of Department of Defense and the starting therapy, the patient’s liver March of Dimes. function improved, his jaundice reSince 2002, Dr. Puder has devoted his research to the pathophysiology of solved, and he was removed from the transplant list. He is now almost 4 parenteral nutrition-associated liver years old and still on parenteral nutridisease (PNALD) and potential treat- M SURGEONS Award Applauds Research Progress n 2004, Dr. and Mrs. Julius H. Jacobson II generously established The Joan L. and Julius H. Jacobson II Promising Investigator Award, as a way of recognizing the vital importance of new knowledge and new technology in promoting the quality of surgical care. This award is intended to recognize outstanding surgeons engaged in research advancing the art and science of surgery who have shown, through their research, early promise of significant contribution to the practice of surgery and the safety of surgical patients. The award of $30,000 is to be given at least once every 2 years. The College’s Surgical Research Committee administers the award. ACGS Seeks to Add Memberat-Large he Membership Committee of the Advisory Council for General Surgery (ACGS) is soliciting nominations for a Member-at-Large in accordance with the following guidelines: Nominees should be Fellows of the ACS and members of their state or local chapter. Nominees should be in active surgical practice. Nominees should recognize the importance of representing all who practice general surgery. Geographic representation and type of practice will be considered. The College encourages consideration of women and other underrepresented minorities. Nominees should be loyal members of the College who have demonstrated leadership qualities that might be reflected by service and active participation on ACS committees or in other components of the College. ACGS advises the Board of Regents on policy matters and formulations; discusses matters that should bebrought to the attention of the Board of Regents; serves as a liaison between general surgery organizations and the Board of Regents; nominates individuals to serve on College committees; and helps develop Clinical Congress programs. Nominations may be submitted to ms@facs.org through April 1. ■ AMERICAN COLLEGE OF I T tion with normal bilirubin levels. A compassionate use protocol has since been developed at Children’s Hospital Boston, and more than 69 children have been treated. To date, no child has died from PNALD at the institution since implementation of the protocol. Dr. Puder has also done extensive work in angiogenesis and on the effect of matrix metalloproteinase activity on wound healing. His training has allowed him to rapidly translate laboratory discoveries to clinical practice. ■

Table of Contents Feed for the Digital Edition of Surgery News - February 2008

Surgery News - February 2008 Contents IOM Committee Looks Into Safety Of Work Schedules Expertise Can Extend Liver Resectability Report Faults Specialty Hospitals' EDs Meeting Expectations Silver Lining HOD on Health Longer Liver Life?

Surgery News - February 2008

For optimal viewing of this digital publication, please enable JavaScript and then refresh the page. If you would like to try to load the digital publication without using Flash Player detection, please click here.