© 2005 Oxford University Press
NEWS |
In Brief
NCI To Revamp Clinical Trials System in 2006
The National Cancer Institute's National Cancer Advisory Board has accepted a 5-year plan for implementation of 22 initiatives for revamping NCI's clinical trials system.
Last year, the Clinical Trials Working Group was charged with redesigning the NCI's clinical trials system to improve efficiency and speed research. The CTWG proposed several changes in the coordination, prioritization, and operation of clinical trials and the standardization of data and procedures.
NCI will spend a total of $112.9 million—$7.1 million in fiscal year 2006, $20.6 million in fiscal year 2007, and then approximately $29 million per year for the following 3 years—on the implementation of the CTWG initiatives. Most of the initiatives will be implemented within the first 3 years, and the final 2 years will be spent moving from implementation into routine practice. The largest portion of the funds will be provided to the extramural research community for improving the quality and efficiency of clinical trials.
The final report from the CTWG is available at http://integratedtrials.nci.nih.gov/ict/CTWG_report_June2005.pdf.
See also News, Vol. 97, No. 8, p. 555, "Standardization, More Funds On Horizon for Clinical Trials," and Vol. 97, No. 2, p. 92, "Redesigning NCI's Clinical Trials System: Integration Is the Goal."
FDA, AstraZeneca Limit Distribution of Gefitinib
Following the finding of an overall lack of benefit of gefitinib (Iressa) in two clinical trials, the drug's maker AstraZeneca and the U.S. Food and Drug Administration have agreed to limit distribution of the drug to patients who currently appear to be responding to the drug, those who have previously taken gefitinib and had a tumor response, and patients who are enrolled in clinical trials.
The FDA gave accelerated approval to gefitinib as a second-line treatment for advanced non–small-cell lung cancer in 2003 based on a surrogate endpoint, tumor response rate. Approximately 10% of patients taking the drug had a response. However, the drug failed to provide an overall survival benefit in later trials required for regular approval.
The FDA is not considering the withdrawal of gefitinib at this time and will reevaluate the drug's status at the conclusion of ongoing clinical trials. AstraZeneca plans to continue evaluation of potential biomarkers that could predict which patients will respond to the drug.
Bortezomib May Be More Effective, but More Toxic, for Multiple Myeloma
Researchers have found that the proteasome inhibitor bortezomib (Velcade) may be a more effective alternative for treating multiple myeloma than the conventional dexamethasone.
In a phase III randomized trial, patients taking bortezomib had a 38% response rate and an average progression-free survival of 6.2 months, compared with an 18% response rate and 3.5 months of progression-free survival for patients taking dexamethasone. Furthermore, 80% of patients on bortezomib were still alive 1 year later, whereas only 66% of dexamethasone patients survived.
Although more effective in the study, bortezomib led to more toxic side effects. About 75% of patients on the drug reported severe or life-threatening adverse events, compared with 60% of patients taking dexamethasone. Of the 331 patients assigned to take bortezomib, 121 (37%) quit taking the drug because of toxicity, compared to 96 (29%) of the 332 patients on dexamethasone. The study was published in the June 16 issue of the New England Journal of Medicine.
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