interim analysis

(redirected from interim analyses)

interim analysis

The analysis of data in a clinical trial comparing intervention groups at any time before the formal completion of the trial, typically before recruitment is complete.

interim analysis

Clinical trials Analysis of early data accumulated in a clinical trial, before all of the Pts have been enrolled, to detect trends that might warrant modification of the protocol, change in type or format of data being collected or, if extreme, trial termination. See CONSENSUS II.
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The oral presentation reviewed interim analyses from two ongoing double-blind, placebo-controlled Phase 2a studies of 731 in HBV subjects evaluating the potential benefit of combination with standard of care Nuc therapy.
Assembly Biosciences presents interim data from two Phase 2a ABI-H0731 trials
The interim analyses for the VX-659 and VX-445 triple combination regimens will enable Vertex to evaluate comparable data from both Phase 3 triple combination programs and determine the best regimen to submit for potential regulatory approval.
Vertex Completes Enrollment of Two Phase 3 Studies of VX-659 in Triple Combination with Tezacaftor and Ivacaftor for the Treatment of Cystic Fibrosis
The size of the DMC also varies--there are usually at least three members but there can be many more DMC members for large studies or for studies that require detailed monitoring and interim analyses.
Establishing a data monitoring committee for clinical trials
The two interim analyses were done to provide information to support the design and execution of Aastrom's Phase 3 CLI program.
Positive interim analysis of Phase 2b RESTORE-CLI clinical trial
Interim analyses using these improved stains show that placental malaria is significantly associated with mother-to-child HIV transmission, and that the presence of malaria increases the mother's HIV viral load.
Malaria and HIV: interplay of risk
The next interim analysis for the OS primary endpoint is scheduled for 2Q19 with additional interim analyses every six months.
Syndax says PFS analysis did not show statistically significant benefit
7 October 2010 - US medical devices maker Baxter International Inc (NYSE:BAX) said yesterday that interim analyses of a Phase III study showed that 28 out of 29 patients with primary immune deficiency (PID), who received the company's HyQ, were able to infuse IG under the skin at infusion volumes, intervals and rates equivalent to previous intravenous administration of IG.
Baxter' HyQ infusions comparable to intravenous administration in Phase III trial in PID patients
Prior to the second interim analysis and with the agreement of the IDMC, the Company had submitted a protocol amendment to the FDA, establishing safety reviews as the basis for the second interim analysis and for subsequent interim analyses. The PAC203 study is evaluating the safety and efficacy of three dosing schedules over 24 weeks in patients with myelofibrosis previously treated with ruxolitinib.
CTI BioPharma announces continuation of PAC203 study after interim data review
The DMC's interim analyses will evaluate safety, efficacy and futility to determine if there is significant evidence of clinical benefit.
Celsion reaches enrollment for Phase 3 OPTIMA study
There will be interim analyses at the 50% and 75% point of the trial as measured by the number of patients treated.
Citius Pharmaceuticals provides update on Mino-Lok Phase 3 Trial

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