April 14, 2000
Could Better Reports by Researchers Have Prevented a Clinical-Trial Death?
Proposals abound as scientists and regulators rethink the system for evaluating 'adverse effects'
A patient in a clinical trial of an experimental brain-cancer medication suffers a series of headaches. The cause is unclear: Did they result from the medication, which has some toxic effects, or from the patient's poor health? Do the headaches qualify as "serious"? As "unanticipated"?
The answers to those questions are key to treating the patient. But they are tremendously
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