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'Phase 0' Trials Aim to Speed Cancer Drug Development
Date:4/17/2009

enormously powerful motivator," explained Hill, adding that he believes it will be the force that drives future participation in phase 0 trials. 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 National Cancer Institute does not offer cancer patients financial incentives to participate in trials, Doroshow said.

Study participants also need to be aware that phase 0 trials, like any trial, might involve invasive procedures, such as blood work and biopsies. Before enrolling in a study, people should ask how it might negatively impact them and how it would positively impact others, LoRusso said.

"Some people would say 'no' because they don't want to be a guinea pig, but there are people out there who want to advance the science for future patients if they can," she said.

More information

The U.S. National Cancer Institute has more on phase 0 trials.



SOURCES: James H. Doroshow, M.D., director, Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, Md.; Patricia M. LoRusso, D.O., director, phase I clinical-pharmacology team, Barbara Ann Karmanos Cancer Institute, and professor, internal medicine, Wayne State University, Detroit; T. Patrick Hill, Ph.D., senior policy fellow, Edward J. Bloustein School of Planning and Public Policy, Rutgers, clinical research ethics consultant, Cancer Institute of New Jersey, New Brunswick, N.J.; Feb 1, 2007, Clinical Cancer Research; April 13, 2009, Journal of Clinical Oncology


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