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Most phase III trials are headed by seasoned leaders in the field. "It is clearly impossible for a young investigator to run a large phase III study," Tannock noted. "And they just don't get the academic kudos for entering patients into a potentially practice-changing phase III study that they do from running a 20-patient phase II study."

Tannock believes that most young researchers do not "consciously" seek to begin a dead-end phase II trial, "but I think the system encourages it." He believes the same paradigm may exist in other areas of medical research, such as heart disease or other illnesses.

Another expert agreed that the preponderance of phase II trials is troublesome.

Dr. Bruce Hillner, a professor of medicine at Virginia Commonwealth University, has researched the issue on a global scale. In a study published in 2003 in the Journal of Clinical Oncology, Hillner found that phase II trials are much more common in the United States than Europe, where more resources are poured into practice-changing phase III trials.

"One of the pressures may be the 'publish-or-perish' that's disproportionately felt by American junior faculty," he said. "The other is the depth of financial entanglements with the pharmaceutical industry."

In some cases, Hillner said, drug companies use promising results from small phase II trials to encourage doctors to use an already FDA-approved drug 'off-label' for another purpose. In this way, he said, the company boosts drug sales while sparing itself the expense of the multimillion-dollar phase III trial that's required for new agency approvals.

Hillner also believes that, in many cases, phase II trials simply aren't presented well enough to garner the wider interest that's needed to take them to the next level.

In many cases, he said, researchers simply label their results "encouraging" or "positive," but never compare them to o
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