Exact(37)
Because these trials involve relatively long follow-up, their protocols usually incorporate periodic interim analyses of the data by a Data and Safety Monitoring Board/Committee.
Many clinical trials include interim analyses of accumulating data and rely on group sequential methods to avoid consequent inflation of the type I error rate.
Interim analyses of a phase I study with GSK2857916, an antibody drug conjugate against B cell maturation antigen, have previously reported a 60% overall response and 7.9 months progression-free survival in relapsed/refractory multiple myeloma (MM).
Interim analyses of PROWESS-SHOCK lead to increased sample size because of lower than expected blinded mortality [23, 24].
An independent data and safety monitoring committee reviewed interim analyses of primary and secondary outcomes as well as safety at least annually.
No interim analyses of the data are planned.
Similar(23)
For reasons of safety, interim analyses on the development of lung injury were conducted after the inclusion of 100 and 150 patients.
In a sequential clinical trial, the accumulating data are subjected to a series of interim analyses, each of which involves a comparison of the treatments under study in respect of the primary efficacy criterion.
We did not conduct interim analyses because of insufficient enrolment of patients.
The SystHERs steering committee provides scientific oversight for the study and is responsible for reviewing patient enrollment/withdrawal from the study, providing recommendations regarding changes in study conduct, reviewing results or interim analyses, conception of new analyses, and participating in drafting and publishing study reports.
Based on the interims-analyses of the outcomes the DSMB can vote for a discontinuation of the study.
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