As it happens the FDA put out a new draft document in
February 2024. It seems that it is the responsibility of the
DSMB (Data Safety Monitoring Board) to determine if there are safety concerns that might effect the conduct of the trial. If the
DMSB has safety concerns then they would recommend to the sponsor (
Theralase) such remedies as trial modification, trial termination, or suspension of enrollment until an uncertainty is resolved. It is then the responsibility of the sponsor (
Theralase) to take immediate action in the interests of patient safety and to alert the
FDA.
Every
MD&A from
Nov. 29 2022 to
Mar. 27 2024 has stated that the
DSMB has confirmed that there have been no serious adverse events related to the Study Drug or Study Device.
"Theralase® believes all SAEs reported to date are unrelated to the Study Drug or Study Device, as reviewed and confirmed by the independent Data Safety Monitoring Board (“DSMB”)" Use of Data Monitoring Committees in Clinical Trials Guidance for Industry Here are some relevent passages from the FDA document:
"This guidance provides recommendations to help sponsors of clinical trials determine when a data monitoring committee (DMC) (also known as a data and safety monitoring board (DSMB) or a data and safety monitoring committee (DSMC) or an independent data monitoring committee (IDMC)) would be useful for trial monitoring and what procedures and practices should be considered to guide their operation." ......
"DMCs have a unique role in clinical trial oversight because they are often the only group with access to accumulating unblinded safety and efficacy data. In order to adequately assess the benefits and risks of an intervention, the DMC should evaluate safety data within the context of the intervention’s efficacy, such that the DMC should have access to safety results as well as comparative efficacy results. Generally, a DMC monitors accumulating safety data and advises the sponsor regarding the safety of the interventions in trial subjects, monitors interim effectiveness results to see whether they support benefit (or futility), and helps to ensure the scientific merit and integrity of the trial." ......
"For trials where there is a potential safety concern, the sponsor should take immediate action, as warranted, in the interest of patient safety and initiate discussion with FDA as soon as possible about the appropriate course of action, both for the trial in question and any other use of the investigational product, before suspending or terminating a trial" ......
"A fundamental responsibility of a DMC is to make recommendations to the sponsor concerning the continuation of the trial. Most frequently, a DMC’s recommendation after an interim review is for the trial to continue as designed. Other less frequent but possible recommendations, however, as discussed previously, include trial termination, trial continuation with major or minor modifications (such as implementation of prespecified adaptive elements), or temporary suspension of enrollment and/or trial intervention until an identified uncertainty is resolved. A DMC should express its recommendations clearly to the sponsor because a DMC’s actions potentially affect the safety of trial subjects."