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Researchers obtained key data within five months of the

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study's initiation, which helped guide the design
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of subsequent phase I trials. "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 I study, the goal is to determine the best way to administer a drug and the maximum dose tolerated with the fewest
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side effects. The first-ever phase 0 trial involved ABT-888, an oral drug that inhibits an enzyme critical for repairing DNA damage. However, he said he sees nothing ethically objectionable about compensating people for reasonable costs they might incur as participants, such as money spent for travel, food and overnight stays. The findings were published online in the Journal
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of Clinical Oncology. Phase 0 studies expose a small number of people to low doses of a drug over a limited period of time -- seven days
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or less. The new model, a so-called "phase 0" clinical trial, promises to streamline the costly and time-consuming drug development
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process, helping to deliver good drugs to people who need them more quickly.

Patrick Hill, senior policy fellow at the Boniface J. 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. Trial participants receive only a limited number of doses -- and much lower doses -- over a shorter period of time. "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. Racial Clusters Affect Access to Colon Care Printer-Friendly Format Email to a Friend. LoRusso, director of the
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phase I clinical-pharmacology team at the Marian Ann Karmanos Cancer Institute in Detroit.

Experts expect the model to be used for other types of drugs as well. However, because small doses of a drug are given for a short period,

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participants probably will not realize a therapeutic benefit. "I think it's going to lay out a very interesting model for other researchers who are also interested in phase 0 studies," said T. Before enrolling in a study, people should ask how it might negatively impact 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. It's believed that the drug could improve

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the effectiveness of chemotherapy. "Altruism is an
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enormously powerful motivator," explained Hill, adding that he believes it will be the force that drives future participation in phase 0 trials. A mere 5% of new oncology drug applications submitted to the U.S. Study participants also need to
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be aware that phase 0 trials, like any trial, might involve invasive procedures, such as blood work and biopsies.
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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. Food and Drug Administration get approved, according to the National Cancer Institute. Scientists look at how the body reacts to the drug and how it acts in the body. As the name implies, a phase 0 trial precedes "phase I" testing, traditionally the first step in the process of human drug testing.

If

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the drug hits its intended target without producing significant side effects, the next phase can be expedited. In fact, 70% of phase II drugs don't make it to the third phase because of a lack of efficacy. Doroshow, director of the division of cancer treatment and diagnosis at the National Cancer Institute in Bethesda, Md. If not, a decision can be made to scrap the drug before it goes on to further, more costly development and testing.

To speed up development, the National Cancer Institute established the NCI Experimental Therapeutics (NExT) program, of which phase 0 trials are an integral

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part. The National Cancer Institute does not offer cancer patients financial incentives to participate in trials, Doroshow said. News Articles Next Article.

"We want to find out if they're ineffective in the smallest number of patients and get definitive information as hailey in the development process as possible," said Dr. One reason is the lack of systems to predict portie on which drugs would be useful and which would have too many side effects, Doroshow explained.


   





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