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The Clinical Trials Participation Awards were first awarded by ASCO 3 years ago to underscore ASCO's commitment to promoting clinical cancer research, and to publicly honor practices and institutions that actively participate in clinical trials research. Awardees are identified by each of the National Cancer Institute (NCI) -funded cooperative groups, and recognized at ASCO's Annual Meeting.
In the first of a series, the Journal of Oncology Practice recognize three practices with outstanding records of patient accrual. These three were Medical Oncology Hematology Associates of Albert Einstein Medical Center, Philadelphia, Pennsylvania; the Breast Imaging Section of Mallinckrodt Institute of Radiology at Barnes-Jewish Hospital in St. Louis, Missiouri; and Evanston Northwestern Healthcare, in Evanston, Illinois.
Every single patient with breast cancer is discussed by a multidisciplinary team. The surgeons (all NSABP members) … often introduce the idea of a clinical trial.
The National Surgical Adjuvant Breast and Bowel Program (NSABP) nominated Medical Oncology Hematology Associates of Philadelphia in recognition of its large recruitment of minorities. This practice is part of the Albert Einstein Healthcare Network. It provides care at two very different locations: the more affluent and largely Anglo community of Northeast Philadelphia, and the less affluent and more ethnically and racially diverse community of North Philadelphia. The North Philadelphia population is largely African American, Hispanic, and Asian. The physicians and nurses of Medical Oncology Hematology Associates manage approximately 12,000 patient visits per year in total, and about 60% of those are in the North Philadelphia location. However, clinical trials are conducted at both sites.
According to Principal Investigator Ajit Desai, MD, the practice has worked hard to overcome the expected problems in recruitment and compliance in North Philadelphia “When the staff becomes closely involved with the patients in clinical trials, providing personal attention and managing the details, most patients feel very connected and follow complicated protocols well. Each patient in a clinical trial is assigned to an experienced nurse specialist who is especially trained to care for their needs,” he said.
The practice employs four nurses dedicated exclusively to clinical research. They follow and care for patients in the clinical trials. “Whatever funding we receive is used to provide the skilled nursing care required by patients in clinical trials,” said Desai.
The clinic's reputation for breast cancer practice has also helped in accrual. Every single patient with breast cancer is discussed by a multidisciplinary team. The surgeons (all NSABP members) who are the patient's primary initial contact, and who present the diagnosis, often introduce the idea of a clinical trial. Thus, when that patient sees a medical oncologist, the suggestion does not come as a surprise.
The clinical research nurses' follow-up includes checking on patients at home, providing them with a calendar to follow, and giving all necessary instructions about what to expect in treatment and tests. “That kind of attention is critical to keep patients on the program, and to follow through with all the protocol-required follow-ups and treatments,” Desai concluded.
The American College of Radiology Imaging Network (ACRIN) nominated the Breast Imaging Section, Mallinckrodt Institute of Radiology, Barnes-Jewish Hospital, St. Louis, Missouri, for its work in the Digital Mammography Imaging Screening trial. This trial compared digital with traditional film mammography, and the nomination reflects the Breast Imaging Section's ability to recruit underserved women. In 1 year, more than 3,300 women were recruited, including more than 500 minority women. Team involvement is also critical to their success.
According to Principal Investigator Dione Farria, MD, the success reflects the section's team approach. The typical traditional model of a clinical trial, according to Farria, is top down, where people simply do the work because it's part of their jobs. In practice it is often a lot of extra work, which can interfere with daily responsibilities. Everyone at every level has to do more: the radiologists, the film library employees, even the technologists. In the view of the Breast Imaging Section, top-down management has limitations. They chose instead to create a team mentality around shared goals and rewards.
Everyone became part of the team, from the administration to the film library people,” said Farria. “Everyone would share in the rewards, so everyone had a vested interest in achieving the goals.” There were even celebrations at key points.
At this institution, the university and the hospital are separate entities that share a common facility. Both parties have an interest in the success of the project, and draw on each other's strength.
The institution's tradition of community outreach helped with the accrual. For several years, the breast health center has taken an active interest in the community, which made it easier to recruit, especially among minorities. Some would think that the perception that St. Louis has a history of racial distrust and a poor medical safety net would make clinical trial accrual difficult. With its history of outreach to African Americans and immigrant populations, the breast center found a public less skeptical to solicitations for participation in research.
Funds came from the Missouri Show Me Healthy Women Foundation, Komen Foundation, and other sources, to help women who wanted to participate in the study but were uninsured or could not otherwise afford the insurance co-payment. The digital mammogram was covered by the study, the other by insurance, which assured that the willing uninsured could participate. Farria observed that it may be easier to raise funds for breast cancer than for other cancers because it has been politically visible for a number of years.
The third award winner profiled in this month's series is Evanston Northwestern Healthcare of Evanston, Illinois. It was nominated by the American College of Surgeon Oncology Group (ACOSOG) group. Principal Investigator David J. Winchester, MD, credits the hospital's success to its research department. This department has a staff of 12, and is funded through clinical work. The staff is involved in teaching, as well as in educational sessions, and regularly attends meetings.
A lot of our success is due to their excellent training, their efforts, and their dedication,” said Dr. Winchester. “If you can carve out funds to have people overseeing this job as their sole purpose, I think your success rate with accruing patients to trials will be much greater. The quality of the data that you collect will be much greater.” He noted that it is increasingly difficult to carve out funds. Physicians have to make sacrifices, he said, because reimbursement is decreasing, as the cost of practicing medicine increases.
The [research department] staff is involved in teaching, as well as in educational sessions, and regularly attends meetings.”
Selection for the award was based on nomination by each of the National Cancer Institute cooperative groups, and the ASCO Clinical Practice Committee, which identified the practices and institutions with the highest rates of accrual to phase III clinical trials over a three-year period. Last year, the cooperative groups nominated practices from among their Community Clinical Oncology Program affiliates. In 2005, the award was presented to practices that have had a high rate of accrual of under-represented minorities.