While the final analysis of the data can occur only after all the data are generated and collected (likely late September/early October 2019), the DSMB
and the study leadership felt the preliminary analysis of the existing data was compelling enough to recommend and implement these changes in the trial immediately.
(Data Safety and Monitoring Board), a committee composed of international independent experts, unanimously recommends continuing the study according to the original protocol, after having analyzed safety data relating to C- Cure and C-Cathez in the ongoing Phase III clinical trial conducted in Europe and Israel.
Medical monitors also help the trial sponsor implement DSMB
recommendations like site conduct changes.
Data Safety Monitoring Boards (DSMBs
) have been developed to monitor and protect the safety of subjects participating in clinical research, particularly those involved in large multicentre, long-term studies.
The placebo arm of the study was ended on 17 May 2004 on the recommendation of the data safety monitoring board (DSMB
) on the basis of interim results.
2) Compare and evaluate different methods and strategies for identifying, reporting, and handling adverse events based on the perspectives of individual participants, institutions, DSMBs
, and/or IRBs.
noted the proportion of patients who have completed Week 36 the primary endpoint target precludes a definitive determination of a treatment effect.
confirmed the absence of any safety issues for the first cohort of three subjects who received a single intravitreal injection of 5e10 vg combined with a wearable optronic visual stimulation device.
The company said it has received Data and Safety Monitoring Board (DSMB
) approval to continue to the final cohort of the study.
Following the DSMB
's recommendation and this early signal of efficacy, the company has initiated recruitment into the randomised part of the trial.
Cox is a consultant to Gen-Probe and Roche, and serves on the Data and Safety Monitoring Committee (DSMB
) for Merck HPV vaccine trials.
The Data Safety Monitoring Board (DSMB
), an independent board monitoring the safety of PLX-PAD, will meet in approximately 30 days to determine dose escalation to the next dose level to be administered in this trial.