Improving the Quality of Cancer Clinical Trials Workshop Summary (2008) / Chapter Skim
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Regulatory Issues
Regulatory Issues
Pages 77-88
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The third session of the second day explored current regulations and how they affect cancer clinical trials. Regulatory Barriers to Innovation The first speaker was former FDA cancer drug regulator Dr.
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This was facilitated by congressional legislation passed in the early 1990s that made it acceptable for Medicare to reimburse for some off-label use of products if that use is supported by clinical research that appears in peer-reviewed medical literature, or if it is listed in one of two compendia; either the American Hospital Formulary Service Drug Information or the U.S. Pharmacopoeia DrugPoints.16 For the former, physicians are responsible for acquiring the supporting medical literature, but this can be challenging in a busy practice, Dr.
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But Dr. Jerian's experience with the SPA is that the more innovative or complex the study design is, and the more it employs the use of complex elements such as biomarkers or adaptive trial designs, the more difficult it is for the trial to successfully complete the SPA agreement process within one 45-day review cycle.
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The restricted use pathway allows for accelerated approval by restricting the use of a drug to certain facilities or physicians with special training or experience, or is conditioned on the performance of specified medical procedures, which could be biomarker tests. Accelerated approval could be granted to a drug if the use of that drug was restricted to those patients predicted to respond to it via biomarker tests.
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Patient Advocacy Perspective The next speaker, Ellen Stovall, a cancer survivor and President and Chief Executive Officer of the National Coalition for Cancer Survivorship (NCCS) , gave a patient advocate's perspective on regulations and what is needed to improve the quality and patient participation in cancer clinical trials.
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Stovall identified as most pressing in the cancer patient advocate community include the recent revisions to CMS requirements for coverage of routine patient care costs within clinical trials, the FDA's ability to follow up on supplemental labeling issues once a drug has been approved under the accelerated approval process, the status of the FDA's issuance of its final guidance on expanded access programs, and proper oversight that ensures adherence to FDA policies in the review of new cancer indications by the Oncologic Drugs Advisory Committee. "Some new drugs have gone to groups to review that don't have the complement of oncology reviewers on them that we would like to see, nor people who understand how these drugs are actually going to be used in clinical practice," Ms.
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Ms. Stovall suggested that patient advocates work with the FDA and clinical trial sponsors to design drug development programs and clinical trials, noting that such cooperation would facilitate greater patient accruals to clinical trials and lead to expanded access to innovative cancer treatments.
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This model would indicate the intended use and targeted performance of the test, what the test population and type of test sites will be, and what the cut-offs are for the test parameters. This feasibility study "works out all the bugs" for the subsequent validation clinical study, Dr.
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The "good news," according to Dr. Gutman, is that the agency has interest in and understanding of adaptive designs and Bayesian statistics, and will let sponsors take regulatory shortcuts by using cautionary labeling and by initially narrowing their claims to bring a test quickly to market, with expanded claims dependent on the collection of future data after the product is on the market.
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Gutman concluded his talk by saying, "FDA has a dual mission across the board -- we are trying to promote public health by getting new diagnostic devices out more quickly, and we are trying to protect public health by keeping bad ones off the market. There is a clear tension which we try to address by applying good science, by asking the right questions." Regulatory Issues in Improving Cancer Clinical Trials In the final talk of the session, Dr.
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Woodcock explained that this is not traditionally done, but may be needed for the innovative targeted cancer drugs that must be combined to be most effective. In addition to commercial concerns, such as the ability of the drug sponsors to work together, a combination treatment trial has to show that each agent makes a contribution to the clinical effect, and has to measure the toxicity of each agent individually, as well as in combination.
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Dr. Woodcock's final suggestion for improving the quality of cancer clinical trials is to standardize all aspects of trial design and execution because the mechanics of trial conduct and execution across all disease areas are extremely suboptimal, she said.
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