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What actions is NCI planning to take to notify patients on other COX-2 inhibitor clinical trials?

April 26, 2017Actions clinical trials cox-2 inhibitor NCI notify Patients planning

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What actions is NCI planning to take to notify patients on other COX-2 inhibitor clinical trials?

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NCI will notify all of the principal investigators of it’s sponsored trials involving COX-2 inhibitors. They will be instructed to notify their institutional review boards, data safety monitoring boards, and participants about this new information. NCI will also require that the informed consent for these trials be revised to reflect this new information and that individuals in the trials be re-consented (asked to sign new consent forms with updated information about risks and benefits of the trials).