July 21st, 2010
FDA Halts New Enrollment in TIDE
Larry Husten, PHD
The FDA has halted new enrollment in TIDE (Thiazolidinedione Intervention with Vitamin D Evaluation), the controversial Avandia safety study, by placing the study on “partial clinical hold.” Patients already enrolled in the trial will continue to participate. The FDA said in a statement that it had instructed GlaxoSmithKline to “update investigators, institutional review boards (IRBs) and ethics committees involved in the TIDE trial” with information derived from last week’s advisory panel meeting. Responding to the FDA action, GSK issued a statement saying that it would suspend enrollment of patients in TIDE and “will work with the TIDE Steering Committee” to send new safety data and a summary of the panel meeting to TIDE investigators and IRBs.
One Response to “FDA Halts New Enrollment in TIDE”
NEJM Journal Watch — Recent Cardiology Articles- Strategies and Criteria for the Diagnosis and Management of Myocarditis
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I would be very interested to learn what CardioExchange readers think about TIDE. Should it be allowed to continue? What are the ethical issues? It strikes me that there are good ethical arguments for why the trial should be continued AND for why the trial should be discontinued.