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"They compare it to a straw man, just saying 'this looks great,' " Hillner said. "This failure to define a benchmark is a major reason why many of these reports are just short-term fireworks."

Another expert agreed.

"While a phase II study might be 'positive,' it may not be as positive as something that's already been tested in a similar patient population," said Dr. Richard Schilsky, ASCO's president-elect and associate dean of clinical research at the University of Chicago.

He called the overabundance of dead-end phase II trials "a tough academic and cultural issue," and agreed that much of the problem is caused by the "publish-or-perish" phenomenon.

"As an academic community, we have to develop a better reward system for people who play important roles in developing these large, multi-center [phase III] trials," Schilsky said. Such a move would give young researchers a way of gaining peer recognition besides heading a phase II trial.

The message for the public is also clear, the experts said.

"The public should also be very cautious about 'exciting' results from phase II trials," Tannock said. "The literature is replete with things that looked very good in phase II but did not prove to be any better than standard treatment in phase III. You have to be careful."

More information

There's more on the clinical-trials process at the U.S. National Cancer Institute.

SOURCES: Ian Tannock, Ph.D., professor, medical oncology, Princess Margaret Hospital and the University of Toronto, Canada; Bruce Hillner, M.D., professor, medicine, Virginia Commonwealth University, Richmond; Richard Schilsky, M.D., president-elect, American Society of Clinical Oncology, and professor, medicine and associate dean, clinical res
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