New discussion: PhV in medical research - XXV

[Guest guest]

Phase IIIData

and Safety Monitoring Boards (DSMB) will be used primarily for randomized

controlled trials.

Responsibilities

of a DSMB:

1. Review interim analyses of

outcome data and to recommend whether the study needs to be changed or

terminated.

2. Determine whether, when, and to whom outcome data should

be released prior to the scheduled reporting of study results at the time

specified in the protocol.

3. Review interim toxicity data.

4. Review major modifications prior to

implementation (e.g. termination, dropping an arm based on toxicity results).

Regards,Dr. Vijay M. KatekhayePostgraduate StudentDept. of Pharmacology,LTMMC & LTMGH, Sion,Mumbai - 400 022 Ph - +919619313060