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NCI has begun a pilot project with the goal of enabling more patients and physicians to participate in phase III cancer clinical trials.
Traditionally, only physicians who are members of NCI cooperative groups have had the opportunity to place patients on large-scale cancer clinical trials. The Expanded Participation Project is designed to extend clinical trial privileges to other qualified oncologists, NCI officials said.
The project will offer oncologists a menu of studies with simplified administration and direct reimbursement for the additional time and effort involved in enrolling patients and collecting research data, NCI said.
The cooperative group system, established in 1955, enrolls about 20,000 patients in NCI-supported multi-institutional clinical trials each year. The 12 groups receive over $140 million in annual funding from NCI and conduct several hundred clinical trials at any given time.
"Cooperative groups have contributed enormously to cancer research," said Richard Ungerleider, EPP project officer and chief of the NCI Clinical Investigations Branch. "Unfortunately, 97 percent of U.S. cancer patients still never participate in a clinical study. The reason is that real or perceived barriers prevent widespread physician participation in cooperative groups."
Sixteen clinical studies for the four most common cancers—breast, lung, prostate, and colorectal—are currently open to EPP physician partners, with more available later this year, NCI said. Each of the studies is still open to its originating cooperative group, which will analyze and publish the results.
The EPP's Internet-based data entry system will allow patient information and study data to be entered directly from physicians' computers.
Because caring for patients in clinical studies requires additional time and effort by the physician and staff, EPP partners are provided $1,500 per patient to cover research-related costs.
The EPP is pilot testing what NCI officials said they hope will become a national network of physicians with access to NCI-sponsored clinical trials. Once under way, this network would allow any oncologist to enroll patients in cooperative group studies via an Internet-based system. By granting wider access to clinical trials, the network should reduce the time it typically takes each phase III study to accrue the hundreds or thousands of necessary patients.
"Trimming the amount of time it takes to complete these studies will speed answers to important treatment questions and quicken advances in cancer care," said Ungerleider.
The EPP is one component of a large-scale plan to restructure and strengthen the NCI clinical trials system. The concept for the EPP grew out of a two-year effort by NCI, its advisory boards, and cooperative group chairmen to study the clinical trials system and develop methods for broadening physician and patient access to trials and completing studies faster.
In 1997, an NCI advisory group, chaired by James Armitage of the University of Nebraska Medical Center, made nearly four dozen recommendations for improving the clinical trials system, including increased funding to the cooperative groups, uniform data collection standards, and improved informatics systems (The Cancer Letter, Oct. 3, 1997).
A second panel, the Clinical Trials Implementation Committee, deliberated for nine months about specific ways to improve the system (The Cancer Letter, Oct. 9 and June 12, 1998).
So far, 12 organizations have joined EPP: APN/Impath Research Co., LLC (Fort Lee, NJ), Cancer Research for the Ozarks (Springfield, MO), Coastal Cancer Center (Myrtle Beach, SC), Green Mountain Oncology Group (Bennington, VT), Hematology & Oncology Associates of Eastern Idaho, PLLC (Idaho Falls, ID), Howard University/PCM (Washington, DC), Kaiser-Permanente Mid-Atlantic (Kensington, MD), Kaiser-Permanente of Northern California (Vallejo, CA), Montgomery & Warmuth M.D., P.A. (St. Augustine, FL), North Idaho Cancer Center (Coeur d'Alene, ID), North Country Oncology/Hematology (Glen Falls, NY), and VA Medical Center (Buffalo, NY).
The EPP Web site is available at: http://light.emmes.com/epp/
For an overview of NCI's clinical trials restructuring, see http://cancertrials.nci.nih.gov/researchers/restructuring
A history of NCI's Cooperative Group Program is posted at: http://ctep.info.nih.gov/CoopGroup/_new/_Coop%20Group%20Prog.html
Aetna No Longer to Cover HDC/BMT For Breast Cancer Outside of Clinical Trials
Aetna U.S. Healthcare, of Bluebell, PA, said that as a result of a South African investigator's admission of falsifying results of a clinical trial, the insurer will no longer cover high dose chemotherapy with bone marrow transplantation for the treatment of breast cancer outside of federally-sponsored clinical trials.
Joseph Carver, Aetna's senior medical director, said the admission by Werner Bezwoda, of University of Witwatersrand, discredited the only clinical trial that provided evidence of the treatment's effectiveness. Bezwoda said he misrepresented the treatment given to the control group in his study presented at the annual meeting of the American Society of Clinical Oncology (ASCO) last May (The Cancer Letter, Feb 11).
"With the South Africa trial discredited, there really is not good scientific evidence that this treatment is any better than combined modality treatment," Carver said. "The little bit of science that was there was pulled away."
Aetna would consider covering HDC with transplantation only in the context of a clinical trial, Carver said.
"There is a clear need to try to answer what is the best course to treat breast cancer, but this can only be answered in the context of a clinical trial," Carver said. "For high dose chemotherapy, we need longer-term analyses to see if the [statistical] curves move apart."
"I honestly believe, not scientifically, but emotionally, that there are subsets where this treatment does make a difference and subsets of patients where it doesn't make a difference, and we need to learn this as soon as possible," Carver said.
Aetna began covering the treatment after the groundswell of publicity about its potential effectiveness in the 1980s and 1990s, which resulted in patient threats of legal action.
"With breast cancer, the ability to have treatment play out in a clinical trial was limited dramatically," Carver said. "We allowed people to receive high dose chemotherapy and bone marrow or stem cell transplants outside of the clinical trial world."
Carver said Aetna's statistics on the number of autologous bone marrow transplantation requests last year before and after the ASCO meeting demonstrate that the medical community has made a decision about the treatment.
From January to May, Aetna approved 105 requests and only 50 were accomplished. From June to December, after the ASCO meeting, 65 requests were approved with only 18 accomplished.
Myriad Genetics Signs Agreement With Kaiser Permanente
Myriad Genetics Inc. (Nasdaq: MYGN) of Salt Lake City, said it has signed a multi-year agreement with Kaiser Permanente for its BRACAnalysis breast and ovarian cancer susceptibility test.
Under the agreement, Kaiser said it would offer the BRACAnalysis test throughout its system to improve the healthcare management of its 8.6 million patients.
Kaiser Permanente said it will join leading insurers and health management organizations such as Aetna US Healthcare and Empire Blue Cross and Blue Shield that have taken the lead in providing coverage for state-of-the-art medical diagnostic services to their members.
The addition of Myriad's BRACAnalysis test to the covered services provided to their members acknowledges the importance of the management of breast and ovarian cancer risk to women's health.
In another development, the company said it would provide NIH scientists and grantees with its BRACAnalysis genetic test of the BRCA1 and BRCA2 breast cancer genes as a research service.
"We are pleased that Myriad Genetics is making its BRACAnalysis molecular diagnostic test available to NIH scientists and grantees to help in further defining the role of these genes in the development of breast and ovarian cancer," said NCI Director Richard Klausner.
Klausner added that the agreement applies to genetic testing for research purposes only, not the delivery of health care services to patients.
Since the discovery of BRCA1 the high cost of testing DNA samples had limited the scope of the research, the company said.
Myriad and NCI created a solution that eased the financial limitations on the magnitude of the research, while providing uniform, high quality genetic testing.
Because the same test can now be used for research that is employed in clinical practice, the data from research studies can be directly applied to the care of patients, the company said.
M.D. Anderson Begins Academic Program In Health Services Research
University of Texas M.D. Anderson announced the implementation of a new academic program in health services research, part of its Division of Cancer Prevention, to define and evaluate effectiveness and efficiency of its own health services.
The program, the first of its kind to focus solely on cancer, will provide information for decision-making and policy analysis about the organization, financing, and delivery of health care.
"As the range of cancer therapies grows and the funding for care is stretched thinner, patients and physicians are being forced to make tough choices every day," said Mitchell Morris, interim chairman, Division of Cancer Prevention. "There is a special need for health services research in oncology, and M.D. Anderson is positioned to develop a model program."
"In the old fee-for-service medical paradigm, there was little impetus for health services research. Health care providers had little incentive to examine the cost-efficiency of care or to respond to consumers' preferences in a non-competitive market," said Morris. "However, we now know that health services research can permit us to be competitive in the healthcare marketplace while ensuring the highest quality of care. It's a win-win situation, and thus the trend to conduct such research."
"This program has the potential to determine best practices and set a benchmark for cancer centers around the world," said Morris.
EntreMed to Begin Phase I Trials of Angiostatin
EntreMed Inc. (Nasdaq: ENMD) of Rockville, MD said it has received permission from FDA to begin phase I clinical testing of Angiostatin.
The first phase I trial site for Angiostatin protein will be Thomas Jefferson University Hospital in Philadelphia.
Walter Curran, chairman, Department of Radiation Oncology, and clinical director of the Kimmel Cancer Center in Philadelphia, and Robert Capizzi, chairman, Department of Medicine, Jefferson Medical College, will serve as co-investigators.
As with the phase I clinical trial of Endostatin protein, now under way at three sites, the phase I trial of Angiostatin protein will use a dose escalation method to determine its safety profile.
Patient enrollment is scheduled to begin this quarter upon final protocol approval from the Institutional Review Board at Thomas Jefferson University. Further information for patients and oncologists will be available through the EntreMed website and the Thomas Jefferson University Hospital website when patient enrollment begins.
"EntreMed successfully developed a production process for Angiostatin protein and transferred that process to large-scale GMP manufacturing at Covance in 1999, said David Jackson, vice president EntreMed Manufacturing.
"We have repeatedly produced highly potent clinical grade material in 2,000-liter fermenters, validating that EntreMed's production process is both robust and easily scalable," Jackson said.
"We were the first to clone Angiostatin protein and the first to express an active recombinant human form of the gene," said Edward Gubish, executive vice president for research and development. "Because Angiostatin protein and Endostatin protein have shown no toxicity, no evidence of drug resistance, and extraordinary safety profiles in preclinical testing, we believe they have broad therapeutic potential."
Clinical Trials Don't Cost an HMO More For Patient Care, Study Finds
When patients at a large non-profit HMO enroll in clinical trials of new cancer therapies conducted by that HMO, the costs of their medical care are only slightly higher than the costs of care for similar cancer patients not in trials, according to researchers with Kaiser Permanente.
"Clinical trials are crucial to the evaluation of promising new cancer treatments, but some health plans may be reluctant to grant their members access to clinical trials because of cost concerns," said Bruce Fireman, lead author and senior biostatistician at KP division of research.
"When we looked at 135 cancer patients who were enrolled in our clinical trials, and compared the costs of their medical care with 135 similar cancer patients who were not enrolled in clinical trials, the care for patients in trials costs about 10% more," said Fireman.
When patients enrolled in bone-marrow transplant trials were excluded from the analysis, the costs of care for trial enrollees were nearly identical to the costs for patients not in trials.
The study, published in the January 19 issue of the Journal of the National Cancer Institute, by Fireman and co-author Lou Fehrenbacher, found that the average cost of medical care for cancer patients enrolled in a clinical trial conducted by KP researchers was $17,000 during the year after enrollment, compared to the $15,500 cost during the comparable one-year period for patients not enrolled in a clinical trial.
Drug costs were not included in the results because drugs used in the trial were donated.
"Bone-marrow transplant trials are costly, but medical care for cancer patients in other trials cost little more than it would have without trials," said Fehrenbacher.
The study examined the direct costs of medical care. A full accounting of the cost of trials would also consider the costs of collecting data, including the research infrastructure.
Kaiser Permanente participates in national multi-site cancer clinical trials as part of its medical research program. The Kaiser Permanente Oncology Clinical Trials research program has involved more than 100 phase III trials and 40 KP oncologists to date. The 10-year-old program has enrolled more than 1,000 patients. Fehrenbacher, director of the KP oncology clinical trials program, is on the board of directors of the National Surgical Adjuvant Breast and Bowel Project.
The study should spur health plans to consider broader access to oncology clinical trials for those patients who want to try them, Fehrenbacher said. "If a patient feels that enrolling in a well-designed phase III trial is the course they want to take, I think we should work hard to provide access to these trials evaluating promising new cancer therapies," he said.
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