Predefined stopping rules included early study termination pending DSMB review/recommendation if major bleeding occurred in two patients infused with ALT-836 within a cohort and study termination or dose modification if one ALT-836 treated patient experienced a major bleeding event.
The DSMB may decide to recommend study termination or protocol modifications if required by the safety data or trial conduct.
The DSMC makes recommendations to the Principal Investigator and the Office of Clinical and Regulatory Affairs at the National Center for Complementary and Alternative Medicine regarding continuation, termination, or other modifications to the study.
Make recommendations to the PI regarding the appropriateness of continuation, termination, or other modifications to the trial based on observed beneficial or adverse effects of the investigational agent in accordance with clearly-defined data-driven algorithms.
Based on the observed adverse effects of the treatment under study, the DSM Body will make recommendations on a regular basis to the PI and the Office of Clinical and Regulatory Affairs at the National Center for Complementary and Alternative Medicine (NCCAM) regarding continuation, termination, or other modifications of the trial.
Any permit noncompliance constitutes a violation of the Clean Water Act and is grounds for enforcement action; for permit termination, revocation and reissuance, or modification; or denial of a permit renewal application.
Any permit noncompliance, except under the terms of an emergency permit, constitutes a violation of the appropriate Act and is grounds for enforcement action; for permit termination, revocation and reissuance, or modification; or for denial of a permit renewal application.
The advisory board supervises the conduct of the study and issues recommendations for early termination, modifications or continuation of the study, if necessary.
The steering committee supervises the conduct of the trial and issues recommendations for early termination, modifications or continuation of the trial, if necessary.
Advisory board An independent scientific advisory board was established to supervise the conduct of the trial and to issue recommendations for early termination, modifications or continuation of the trial, if necessary.
