Revive Therapeutics Ltd (RVVTF)

[Team Moth]

Every modification to this rdbpc trial had to be given final approval by the dsmb alone, not mf nor pharmolam because only the dsmb sees the interim and cumulative data.

If the outcomes were not acceptable we would have been shutdown long ago since the dsmb has all the power to do so.





The DSMB should conclude each review with their recommendations to NIDCR as to whether the study should continue without change, be modified, or be terminated. Recommendations regarding modification of the design and conduct of the study could include:

- Modifications of the study protocol based upon the review of the safety data;

- Suspension or early termination of the study or of one or more study arms because of serious concerns about subjects’ safety, inadequate performance, or rate of enrollment;

- Suspension or early termination of the study or of one or more study arms because study objectives have been obtained according to pre-established statistical guidelines;

- Optional approaches for NIDCR and investigators to consider when the DSMB determines that the incidence of primary study outcomes is substantially less than expected (such as recommendations to increase the number of trial centers or extend the recruitment period); and,

- Corrective actions regarding a study center whose performance appears unsatisfactory or appears to raise questions regarding the conduct of the study.