Researchers urged to resist early declaration of trial success

Drug developers are typically quick to trumpet the news of an early end to a clinical trial--provided they're seeing the kind of promising results they hoped for. But a new study reviewing the fate of drugs involved in 100 clinical trials ended early for positive reasons concludes that premature termination is a bad idea.

"Our research shows that in most cases early stopping of clinical trials resulted in misleading estimates of treatment effects. These misleading estimates are likely to result in misguided decisions about the trade-off between risks and benefits of a therapy," says Victor Montori, M.D., Mayo Clinic endocrinologist and corresponding author of the study. "On average, treatments with no effect would show a reduction in relative risk of almost 30 percent in stopped early trials. Treatments with a true relative risk reduction of 20 percent would show a reduction of over 40 percent."

Everybody, from researchers to developers to doctors and scientific journals do better when they can declare success early, says Montori. Everybody, that is, except patients. And that's why he's calling on researchers to push back when they feel pressure to announce a victory before the full battle is over.

- for more of the data check out this release

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