Multi-Center Phase III Clinical Trials and NCI Cooperative Groups Workshop Summary (2009) / Chapter Skim
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Session 3: Data Collection Standards and Monitoring
Session 3: Data Collection Standards and Monitoring
Pages 65-74
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From page 65... ...
However, some clinical trials investigators have suggested that the NCI and the FDA reduce the amount of audits and data required, thereby streamlining the clinical trials process and saving both time and money. At the same time, additional data and resources are needed for today's trials -- such as those for targeted therapies -- to identify patient candidates for new therapies, for biomarker analysis, and more.
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From page 66... ...
He noted that the NCI regularly audits 10 percent of the patient cases at cooperative group sites and determines major deficiencies related to a number of factors listed in Box 5. But he noted that there are no standards for these auditing data and no comparative data against which to measure them.
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From page 67... ...
Gwendolyn Fyfe, senior staff scientist in clinical hematology and oncology at Genentech, gave the industry perspective on data collection and monitoring. She said that much of
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From page 68... ...
"I'm not sure that all the specific stop and start dates helped us understand the safety profile of bevacizumab." Dr. Fyfe noted that much of the data collected on adverse events is superfluous, because it merely improves confidence intervals without changing clinical decisions.
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From page 69... ...
She added, however, that detailed adverse-event profiles in subpopulations are usually inadequately answered in Phase III trials and are probably better addressed in Phase II or Phase IV trials or through post-marketing registries. She suggested that a set of data standards could ensure that the data collected are adequate to reliably assess whether an unapproved agent has a good risk-to-benefit ratio, including the issue of whether the drug significantly improves outcome when added to or in contrast to a known standard, and also what the effect on safety is when that drug is added to or substituted for a known treatment standard.
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From page 70... ...
. The committee recommended that in designing clinical trials, data collection should be reduced and that investigators should collect only data pertinent to studying endpoints and safety.
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From page 71... ...
Dr. Comis suggested that cooperative groups, government agencies, and industry develop evidence-based standards for Phase III trials, including standards for data collection, data and site monitoring, and the content of case report forms.
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From page 72... ...
He suggested considering these innovative analyses of radiologic findings when developing data and review standards. A few attendees raised the issue of industry funding of cooperative group trials and the effect that this might have on the data collected and reported.
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From page 73... ...
Fyfe's comment that new toxicities are rarely found during Phase III trials, because they are already documented in Phase II trials. Industry and investigators "have been cutting off a lot of the Phase II activities," he said, "and therefore we have lost a lot of learning opportunities." He suggested a few remedies, such as doing more randomized Phase II studies before proceeding to Phase III studies or having an independent data and safety monitoring committee that is program-wide for Phase II studies.
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From page 74... ...
Dr. Buckner noted that the NCI typically does not require data collection on attribution of adverse events, whereas the FDA does.
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