Gilead Sciences' Phase III Study evaluating Zydelig (idelalisib) added to standard therapy in previously-treated chronic lymphocytic leukemia (CLL) will be unblinded early following the recommendation by an independent Data Monitoring Committee
(DMC) based on a interim analysis indicating a statistically significant benefit in efficacy for progression-free survival (PFS) and overall survival (OS).
After an early efficacy review by the Independent Data Monitoring Committee
(IDMC), AstraZeneca has decided to stop the study as it is deemed unlikely to benefit patients.
Late-stage testing of the drug, elesclomol, was halted in February after an independent data monitoring committee
observed a higher number of deaths and other safety concerns.
The independent data monitoring committee
(IDMC) charged with overseeing this study has on four occasions reviewed the mortality and all serious adverse event data and has four times recommended that the study continue without modification.
Obseva Gets Nod From Independent Data Monitoring Committee
To Proceed With Trial Of Preterm Labor Drug
A planned interim analysis conducted by an Independent Data Monitoring Committee
concluded that the trial has met its primary endpoint by showing a statistically-significant and clinically-meaningful improvement in OS in patients treated with Imfinzi in combination with standard-of-care etoposide and platinum-based chemotherapy options vs.
After notifying the company of the interim results, the trial's Independent Data Monitoring Committee
(IDMC) said they had no safety concerns about MPC-150-IM and urged that the trial continue as planned.
A late-stage trial of the drug, elesclomol, was suspended last month after an independent data monitoring committee
observed higher number of deaths and other safety concerns.
Tocagen last night announced that the Toca 5 Phase 3 clinical trial evaluating Toca 511 and Toca FC in patients with recurrent high grade glioma continues without modification following a planned interim analysis of data conducted by an Independent Data Monitoring Committee
. The IDMC completed its analysis and recommended the trial continue without modification, the company said in a statement.
This followed an Independent Data Monitoring Committee
meeting in July 2018, where the committee recommended that the CREDENCE trial stop early because it met the prespecified criteria for efficacy.
Safety data from all six subjects was reviewed by an independent Data Monitoring Committee
and approval was provided to commence with Cohort 2.