A Mayfield Clinic neurosurgeon has gotten an FDA warning letter alleging that problems with record-keeping, reporting of adverse events and enrollment of patients in a study he was conducting. The FDA asserts that Dr. William Tobler and his team didn't document adequately that subjects were screened for study eligibility, kept inaccurate records and post-dated reports years after the fact. It also contends that Tobler did too little to respond to an earlier FDA critique of how the research was managed.
The study, which took place between May 2003 and August 2006, was part of a multi-center trial comparing a device used in spinal fusions for disk degeneration to other approaches. During the study, seven patients received the device, and all fared well, the clinic said in a press statement.
To learn more about the warning:
- read this Business Courier of Cincinnati piece [1]
Links:
[1] http://www.bizjournals.com/cincinnati/stories/2007/09/17/daily27.html?b=1190001600^1522582