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This month, JOP recognizes the final three of the twelve 2005 Clinical Trials Participation Award winners: Presbyterian Hospital of Dallas, Texas; Mount Sinai Medical Center of Miami Beach, Florida; and the Cedar Rapids (Iowa) Oncology Project Community Clinical Oncology Program (CCOP).
Established 3 years ago, the Clinical Trial Participation Awards underscore ASCO's commitment to promoting clinical cancer research. Selection of winners is based on nomination by each of the National Cancer Institute cooperative groups and the ASCO Clinical Practice Committee, which identified the practices with the highest rates of accrual to phase III clinical trials over a 3-year period. In 2005, the awards were presented to practices that also had a high rate of accrual of under-represented minorities.
Presbyterian Hospital of Dallas, Texas, is a community hospital with approximately 500 beds, and James F. Strauss, MD, is director of oncology research. The hospital began its trials program in 1991.
“At that time there was no clinical research going on in the hospital in oncology,” said Strauss, “but the administration agreed that it was important to the mission of the hospital.”
Along with making studies available to patients, Strauss believes that research improves a hospital's quality.
“Research puts doctors in touch with the opinions of the cancer site committees and the cooperative groups, so they're aware of the ideas considered appropriate for study, and of the studies considered most appropriate for comparison,” he said.
Strauss envisioned a clinical research program with high-quality data collection. He believed the hospital should enroll patients onto studies with valid research potential that were worthwhile both scientifically and from the patient's point of view.
“In order to do that, we concentrated mainly on cooperative group studies, because of the high quality of the questions being asked, and the quality of data management,” he said. “We obtained affiliations with the Southwest Oncology Group [SWOG] and with NSABP [National Surgical Adjuvant Breast and Bowel Project], and relied on the training that those organizations provided for data managers.”
The hospital began by focusing on cancer prevention trials and additional adjuvant studies sponsored by NSABP and SWOG.
“Some of these studies have turned out to be very worthwhile in defining the standard of care,” said Strauss.
More recently, they have participated in phase I and II studies.
As for serving underserved populations, Strauss notes that the hospital is involved in community outreach and education.
“Our study enrollment reflects the population percentages coming in the hospital's front door. We want to make studies available to every patient, and the record shows that we're doing that,” he concluded.
Mount Sinai Medical Center in Miami Beach has had a CCOP grant since 1987, and is currently participating in approximately 65 clinical trials. Michael Samuels, MD, is vice chairman of the Department of Radiation Oncology at the Center and is co–principal investigator of the hospital's CCOP. Janice Grimes is CCOP coordinator.
According to Samuels, the Radiation Therapy Oncology Group selected Mount Sinai not only for its work with underserved or non–English-speaking populations, but also as an example of a community institution that has had great success at clinical trial accrual.
“We are predominantly a community hospital, and the CCOP program proves that even outside of the strictly academic setting, community medical oncologists, radiation oncologists, and surgeons can activate clinical trials that meet the needs of their populations, and enroll large numbers of patients” said Samuels. “These trials can be executed with high levels of quality in the community setting, and I don't think that the medical community as a whole necessarily realizes that. It is a misconception that only large academic institutions can perform significant clinical research.”
Samuels believes that the benefits will accrue to future patients, but that community oncologists must share this responsibility.
“Frankly, if more community institutions were to participate through the CCOP process,” he said, “the number of patients accrued to clinical trials could go way up.”
As for including underserved populations, this is not an issue at Mount Sinai, where minority accrual is between 25% and 30% each year. “We have large groups of patients who are not native English speakers and who have limited education and resources. They do not necessarily come to us looking for clinical trials. We try to offer them clinical trials, and encourage their participation, just as we do with our more educated and affluent patients.”
Language is no barrier. “We are so used to providing our discussion in any language that the patient needs, it's almost something we don't even think about,” said Samuels. “Translation is a routine part of our program,” he said.
The Cedar Rapids Oncology Project CCOP is a consortium of two community hospitals in Iowa, St. Luke's and Mercy Medical Center, and serves a medical service area of approximately 400,000 people. It has been involved with clinical trials for 20 years, and has been a funded CCOP since 1990. Martin Wiesenfeld, MD, FACP, a medical oncologist, is principal investigator.
Although the hospital's population base is not primarily minority, this CCOP has tried hard to recruit minorities, and improve access to clinical trials for minority populations. Wiesenfeld notes that the two hospitals serve a relatively underserved rural area, with patients coming from distances up to 100 miles. Rural areas and poor urban areas have some things in common, including a high incidence of smoking and limited access to cancer screening.
“Smaller communities in rural areas need access to screening, to prevention trials, to clinical trials,” said Wiesenfeld, “and these are provided by the CCOP.”
Wiesenfeld is a firm believer in clinical trials participation for all population groups. “That is the step to transfer the newer technologies, and to make studies available in a controlled way into the communities,” he said. “We all need this kind of base of participation to validate the results of research, and that is doable in a community setting.”