Some analysts have said clear-cut, favorable data could emerge long before the study is completed, and that the data safety monitoring board
might therefore halt the study early.
Fremont, CA announced that an ad hoc independent Data Safety Monitoring Board
(DSMB) decided to close the company's comparative kidney transplant study early after an interim analysis revealed significantly fewer rejections in patients treated the Thymoglobulin [Anti-thymocyte globulin, (Rabbit)] versus Novartis' Pharmaceutical's, East Hanover, NJ, Simulect (basiliximab).
The finding came during an ongoing international clinical trial of pomalidomide when the data safety monitoring board
allowed all patients in the trial to receive pomalidomide instead of just a comparison regimen.
serves on the data safety monitoring board
for Sanofi-Pasteur and Merck, and is an occasional consultant for Novartis, GlaxoSmithKline, and Pfizer.
To date the trial has successfully passed six safety reviews by its independent Data Safety Monitoring Board
Antonio Bartorelli (Milan), chairing the independent Data Safety Monitoring Board
and the Critical Events Committee of the study.
Because the difference was statistically significant and met the pre-determined standard for stopping a treatment arm, the Data Safety Monitoring Board
(DSMB) had no choice but to stop abacavir plus A ZT plus 3TC and offer the participants other treatment.
Grossberg, who has been a consultant to Novartis and served for 3 years on a data safety monitoring board
LOS ANGELES -- CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical company specializing in oncology, today announced the recommendation by the Data Safety Monitoring Board
(DSMB) to continue with the global Phase 2b clinical trial with tamibarotene in combination with chemotherapeutical agents as a first-line treatment for patients with advanced non-small-cell lung cancer (NSCLC).
The independent Data Safety Monitoring Board
(DSMB) has recommended the trial continue enrollment as planned.
In February 2010, the data safety monitoring board
recommended termination of the study based on results from an interim analysis showing apixaban to be superior to aspirin in reducing stroke and systemic embolism.
It supports the use of a data safety monitoring board
, which is currently planned, but wants it to be more independent of government agencies.