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17 April 2014 12:48 pm ,
Vol. 344 ,
Officials last week revealed that the U.S. contribution to ITER could cost $3.9 billion by 2034—roughly four times the...
An experimental hepatitis B drug that looked safe in animal trials tragically killed five of 15 patients in 1993. Now,...
Using the two high-quality genomes that exist for Neandertals and Denisovans, researchers find clues to gene activity...
A new report from the Intergovernmental Panel on Climate Change (IPCC) concludes that humanity has done little to slow...
Astronomers have discovered an Earth-sized planet in the habitable zone of a red dwarf—a star cooler than the sun—500...
Three years ago, Jennifer Francis of Rutgers University proposed that a warming Arctic was altering the behavior of the...
- 17 April 2014 12:48 pm , Vol. 344 , #6181
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Speeding Up Cancer Drug Development
3 June 2003 (All day)
Two U.S. agencies are teaming up to accelerate the design and approval of cancer drugs--the National Cancer Institute (NCI) and Food and Drug Administration (FDA). They announced the initiative on 30 May at the annual American Society of Clinical Oncology meeting in Chicago, Illinois.
The new plan calls for developing improved biomarkers to help assess a drug's effectiveness, enhancing design and evaluation strategies for cancer-preventing medications, and introducing new endpoints for measuring the success of cancer drugs. These might include inhibiting certain enzymes or specific molecular targets. The agencies are also interested in identifying protein markers in the blood that might provide clues as to how a drug is working, which could enhance the design of clinical trials.
The effort fits with NCI director Andrew von Eschenbach's goal of eliminating death and suffering from cancer by 2015 (Science, 28 February, p. 1297). In addition, FDA, under its new director Mark McClellan, has also been exploring ways to assess whether or not a cancer drug is effective. The agency already relies on a number of endpoints, including survival, tumor shrinkage, and easing of symptoms.
Some observers worry that new endpoints could cause FDA's standards to slip: "Is this going to allow drugs to get on the market based on less rigorous studies?" asks Peter Lurie, deputy director of health research at Public Citizen, a Washington, D.C., advocacy group. Lurie is concerned about moving away from the basic index of efficacy--extended survival. But Richard Pazdur, director of FDA's cancer drug division, says that standards will hold firm. "We're not trying to subvert" the drug approval process, he says.