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Monday, 10/19/2020 12:33:48 AM

Monday, October 19, 2020 12:33:48 AM

Post# of 232963
7.3. DMC Recommendations for Protocol Changes
A DMC may, in some instances, recommend changes to the study protocol, particularly in the context of their responsibilities for monitoring patient safety. Many protocol changes have little impact on the usefulness of a trial to gain regulatory approval. Certain types of changes to the protocol, however, such as changes in the primary endpoints, could have substantial impact on the validity of the trial and/or its ability to support the desired regulatory decision if they potentially could have been motivated by the interim data. We recommend that sponsors discuss proposed changes of the latter type with FDA before implementation.

We donot have any safety issues so highly unlikey that dsmc recommended an end point change based on efficacy. Not their job duty listed.

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