DSMB. 1. What role, what responsibilities?

In addition to the IRB (Institutional review board), the DSMB (data safety and monitoring board) takes an increasing role in the monitoring of clinical trials, especially in large multicenter trials. The DSMB is a an expert committee, independent from the investigators and the sponsor of the trial, which periodically examines the safety data accumulated during progress of the trial and ensures that the benefit/risk ratio remains acceptable for participating patients. The DSMB is also a safeguard for the scientific integrity of the trial. It is the only committee which can have access to unblinded data from the trial. The DSMB may recommend termination of the trial in three situations : (1) occurrence of unanticipated adverse events which may pose a serious risk for participating patients; (2) demonstration of efficacy before the planned accrual \; (3) and because of "futility" (the most difficult situation), i.e. in absence of a reasonable probability that the trial may reach a conclusion within its planned frame.     

Abstracts from “Neirokhimiya,” Vol. 17, No. 1, 2000

Abstract List

Abstracts from Neirokhimiya, Vol. 17, No. 1, 2000     

THE COPEPODA OF THE WU-L1 LAKE, WU-SIH, KIANGSU PROVINCE. Ⅱ. CYCLOPOIDA

This is the second part of a series of papers dealing with the Copepoda-fauna of theWu-Li Lake, Wu-Sih, Kiangsu Province, China. It comprises 21 species of Cyclopoida,of which 5 species (those marked with an asterisk in the list) are for the first time re-corded in China and two species of Tropocyclops are found to be new to science. All