Improving the Quality of Cancer Clinical Trials Workshop Summary (2008) / Chapter Skim
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Costs of Clinical Trials
Costs of Clinical Trials
Pages 67-76
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From page 67... ...
Costs of Clinical Trials Clinical trials of new cancer drugs are expensive, and with implementation of better, more sophisticated studies, costs are projected to rise. Although the use of predictive biomarkers to enrich study populations might make smaller trials more likely to succeed, they pose the added costs of the biomarker tests and raise the issue of who will pay for those added costs.
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From page 68... ...
Schulman pointed out. Of nine functional steps identified for the conduct of high-quality trials, six include elements 12The Clinical Trials Cooperative Group Program, which is sponsored by the NCI, is designed to promote and support clinical trials of new cancer treatments, explore methods of cancer prevention and early detection, and study quality-of-life issues and rehabilitation during and after treatment.
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From page 69... ...
Dr. Schilsky added that there is unnecessary redundancy and a lack of harmonization among the multiple organizations that review clinical trials.
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From page 70... ...
By the time you enter one patient in a study, you have already spent 5 or 6 thousand dollars that neither government nor industry reimbursement will probably make up." But Dr. Doroshow voiced some optimism by noting that in 2005, NCI-supported cancer centers accrued 41,000 patients to treatment trials, with only a quarter of those supported by pharmaceutical companies.
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From page 71... ...
, and other major cancer-related organizations to inform physicians and patients about cancer clinical trials currently accruing patients. For example, the Coalition helped the ACS establish a search engine on its website, called Trial Check, which can be used to search for cancer clinical trials.
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From page 72... ...
Fyfe described the cost savings that could be gained if patient recruitment occurred more quickly and more robustly, as the length of a trial is often extended because of delays in patient accrual. If 25 to 50 percent of all eligible cancer patients enrolled in clinical trials, she said, "the cost of trials would decrease dramatically because you would have fewer sites, trials would take less [time]
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From page 73... ...
Samir Khleif from the NCI pointed out that the majority of the countries that rank above the United States, such as France and Canada, have socialized medicine in which physicians are paid salaries. Therefore, spending more time enrolling patients in clinical trials does not have a negative impact on their income.
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Dr. Schulman countered that electronic data capture will not sufficiently speed up the time it takes to start up a clinical trial because much of that time is due to "onerous" regulations.
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From page 75... ...
Such trials are funded by either industry or the NCI. Industry tends to do early-phase testing and the NCI tends to fund mainly Phase III trials, most of which are to extend the indications of already approved drugs.
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From page 76... ...
The budget for the cooperative groups is about $150 million annually, and that is used to support about 500 active clinical trials, including about 80 or 90 Phase III trials, he said. "Tell me any pharmaceutical company that can operate 80 or 90 Phase III clinical trials on a $150 million budget.
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