Regarding the misfortunes of the ENHANCE study, The Star-Ledger reports:
In a break from standard clinical trial procedure, Merck and Schering-Plough oversaw the trial instead of a panel of outside scientists. There also was no safety monitoring board to oversee the health of clinical trial volunteers, which is typically appointed in studies involving new drugs.
Merck and Schering-Plough have said the participation of outside scientists and safety-monitoring boards is optional in such studies.
The most troubling shortcoming, the experts said, came when Schering-Plough's statisticians reviewed some raw study data in April 2006 before the examinations of all 750 volunteer test subjects at 11 sites around the globe were complete.
Critics protest the statisticians may have had a hint of the study's disappointing outcome.
"That is the key irregularity," said Eric Topol, a respected cardiologist and director of the Scripps Translational Science Institute, in La Jolla, Calif., who criticized the study's "poor organization, poor planning."
"Maybe everything is on the up and up," he said, "but the right questions need to be answered."
More at The Star-Ledger
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