Multi-Center Phase III Clinical Trials and NCI Cooperative Groups Workshop Summary (2009) / Chapter Skim
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Summary and Wrap-Up
Summary and Wrap-Up
Pages 91-96
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From page 91... ...
He agreed that cooperative groups are going to be turning more and more to industry for financial support, and he noted a number of advantages that the cooperative groups offer industry, including diversity of subjects, numerous sites, and tissue banks that enable the genetic studies underlying personalized medicine. He suggested that the leaders of cooperative groups and large pharmaceutical companies come together to decide what studies are best run by cooperative groups and what studies are best run by industry.
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From page 92... ...
The protocols that emerge are generally high quality, he said, and most are ultimately executed. "For some of the highpriority Phase III types of studies that we are trying to do, a similar type of approach could be used where you actually bring together all the relevant stakeholders, including empowered representatives from the relevant sponsor, cooperative group setting, biostatistics, and regulatory agencies, and craft the protocol within a compressed timeline," he suggested.
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From page 93... ...
There was general agreement that collaboration with industry helps stretch the modest resources of the Cooperative Group Program, but many expressed concern that such collaboration results in restrictions on the publication of data. There was little agreement on how to address problems with IRBs, especially in light of the different types of IRBs engaged in the process: locally based IRBs, the NCI-based central IRB, and private, commercial IRBs.
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From page 94... ...
• onsider increasing randomized Phase II trials and reducing Phase III C trials. National Cancer Institute • educe CTEP-sponsored reviews of clinical trials, especially when they do R not involve a new unapproved agent.
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From page 95... ...
• or new, marginally active drugs and drugs approved based on response or F time to progression, consider a policy that requires participation in a clinical trial in order to receive reimbursement for the cost of care, akin to what is done in the United Kingdom. • educe requirements for collecting and reporting data on clinical trials to R those essential for evaluating safety and efficacy.
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