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Before enrolling in a study, people should ask how it might negatively impact

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them and how it would positively impact others, LoRusso said. "We need to have a better handle on whether or not they are going to be useful sooner," he added. 'Phase 0' Trials Aim to Speed Cancer Drug Development -- Even after years of painstaking research and testing, only a small percentage of cancer agents make it from the laboratory to the patient. Experts expect the model to be used for other types of drugs as well. So scientists have come
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up with a way to weed out the duds earlier in the process and speed good medications to the marketplace.

Trial

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participants receive only a limited number of doses -- and much lower doses -- over a shorter period of time. "I think it's going to lay out a very interesting
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model for other researchers who are also interested in phase 0 studies," said T. A mere 5 percent of new oncology drug applications submitted to the U.S. However, he said he sees nothing ethically objectionable about compensating people for reasonable costs they might incur as participants, such
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as money spent for travel, food and overnight stays. "Some people would say 'no' because they don't want to be a guinea
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pig, but there are people out there who want to advance the science for future patients if they can," she said.
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Phase 0 trials expose people to less toxicity and involve fewer participants -- 10 to 12, on average, versus 20 to 25 in a phase I trial. If the drug hits its intended target without producing significant side effects, the next

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phase can be expedited. Study participants also
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need to be aware that phase 0 trials, like any trial, might involve invasive procedures, such as blood work and biopsies. Food and Drug Administration get approved, according to the National Cancer Institute. "Altruism is an enormously powerful motivator," explained Hill, adding that he believes it will be the force that drives future participation
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in phase 0 trials. National Cancer Institute has more on phase 0 trials.. It's believed that the drug could
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improve the effectiveness of chemotherapy.

To speed up development, the National Cancer Institute established the NCI Experimental Therapeutics (NExT) program, of which phase 0 trials are an integral part. One reason is the lack of systems to predict carver on which drugs would be useful and

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which would have too many side effects, Doroshow explained. As the name implies,
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a phase 0 trial precedes "phase I" testing, traditionally the first step in the process of human drug testing. Phase 0 studies expose a small number of people to low doses of a drug over a limited period of time -- seven days or less.

However, because small doses of a drug are given for a short period, participants probably will

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not realize a therapeutic benefit. Doroshow, director of the division of cancer treatment and diagnosis at the National Cancer Institute in Bethesda, Md. The findings were published online in the Journal of Clinical Oncology. Giovanni Hill, senior policy fellow at the Keir J. The
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National Cancer Institute does not offer
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cancer patients financial incentives to participate in trials, Doroshow said. Bloustein School of Planning and Public Policy at Rutgers, and a clinical research ethics consultant at the Cancer Institute of New Jersey, both in New Brunswick. The first-ever phase 0 trial involved ABT-888, an oral drug that inhibits an enzyme critical for repairing DNA damage.

"We want to find out if they're ineffective in the smallest number of patients and get definitive information as rockie in the development process

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as possible," said Dr. More information The U.S. In fact, 70 percent of phase II drugs don't make it to the third phase because of a lack of efficacy. The new model, a so-called "phase 0" clinical trial, promises
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to streamline the costly and time-consuming drug development process, helping to deliver good drugs to people who need them more quickly. "It may help accelerate clinical drug development in oncology because you're able to theoretically get the drug into man faster and learn more about the drug in man earlier," explained Dr. In a phase
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I study, the goal is to determine the best way to administer a drug and the maximum dose tolerated with the fewest side effects. LoRusso, director of the phase I clinical-pharmacology team at the Beryle Ann Karmanos Cancer Institute in Detroit.

Researchers obtained key data within five months of the study's initiation, which helped guide the design of subsequent phase I trials. Scientists look at how the body reacts to the drug and how it acts in the body. If not, a decision can be made to scrap the drug before it goes on to further, more costly development and testing.

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