Multi-Center Phase III Clinical Trials and NCI Cooperative Groups Workshop Summary (2009) / Chapter Skim
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Session 1B: Lessons from Non-Cooperative Group Multi-Center Clinical Trials
Session 1B: Lessons from Non-Cooperative Group Multi-Center Clinical Trials
Pages 27-40
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From page 27... ...
Organization of Multi-Center Clinical Trials Dr. Robert Califf is a cardiologist, vice chancellor for clinical research, and director of the Duke University Translational Medicine Institute.
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From page 28... ...
He pointed out that while academic centers do not do clinical trials to generate additional income, there are other benefits of doing such research, including enabling delivery of innovative therapies to patients, aiding in determining the best medical practices, and providing extra care to patients without additional cost. More fundamentally, however, academic research centers conduct clinical research because research itself is a core mission of the institution, Dr.
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When the attendees calculated the costs of doing a specific clinical trial protocol by various methods of organization, they found massively different cost estimates for the same trial generating the same results that would pass FDA scrutiny (Figure 2)
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At the Sensible Guidelines for the Conduct of Clini cal Trials Conference, representatives from academia, industry, and government agencies convened to discuss approaches to reduce bureaucracy in clinical trial design and conduct. Attendees reached massively different cost estimates for a specific clinical trial protocol that would generate the same results and still pass FDA scrutiny.
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Renzo Canetta of Bristol–Myers Squibb gave the industry perspective on industry-sponsored multi-center clinical trials, which, as he noted, have increasingly become multinational clinical trials. A survey of FDA-registered investigators reveals that although slightly more than half are from the United States, an increasing number are from European countries, Russia, India, and Argentina (Parexel International Corporation, 2008)
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From page 32... ...
us was how few patients do we have to put in the United States to be credible with the FDA. In other words, there is a mandate to not enroll patients in the United States because of the dynamics." The globalization of clinical trials has had several consequences, including the need to fulfill numerous different local regulations in study activation, monitoring, and adverse event reporting, which results in the generation of extensive final clinical study reports that can be 1,000 pages long.
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From page 33... ...
Once a protocol is approved, there are numerous costs to industry involved in running a multi-center clinical trial, Dr. Canetta said, including funding for the personnel and infrastructure needed to run the trial; the fees of adjudication committees, IRBs, and data management centers; travel and meeting costs; and the costs of additional tests and procedures that are not reimbursed by insurers.
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From page 34... ...
Dr. Canetta suggested mixed partnerships with cooperative groups whereby the cooperative group uses its own members and industry provides additional international investigators that industry takes the responsibility to monitor.
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"That will be really detrimental to the public interest." Dr. Schilsky added that there probably would be fewer adjuvant therapy trials, fewer combined modality clinical trials, and fewer comparative effectiveness trials, "and lots of other things that the cooperative groups do that are important to patients," he said.
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From page 36... ...
He noted that the fixed costs involved with the development and regulatory and quality-assurance oversight of a clinical trial make up one-quarter of the costs of running a trial. Practice costs, study operations, and management account for about half the cost, and the remaining quarter is spent on direct research expenses and physician compensation, which in Dr.
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From page 37... ...
Although he recognizes that such disclosure is important, it often is not relevant, as in the case of double-blind studies or studies in which an individual investigator does not manage the study data or contributes a small percentage of the cases and cannot block publication of negative data. He recommended requiring financial disclosure only for physicians who author the study report and contribute more than 10 percent of the patients in non-blinded studies or who own 5 percent or more of company stock.
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From page 38... ...
So we need to open this up across the country and make the system a lot simpler." The increasing availability of more effective cancer drugs for second- and third-line indications for patients who did not respond or are no longer responding to initial treatment also limit patient accruals for experimental drug trials. Poor Medicare reimbursement for prescription drugs is also limiting patient participation in clinical trials and physician willingness to undertake these trials.
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From page 39... ...
"This has become virtually an absolute negative for any such patient to be able to afford to go into a clinical trial," he said (Lin et al., 2008)
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