interim analysis


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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.
References in periodicals archive ?
AbbVie announced that MERU, a Phase 3 trial evaluating Rova-T as a first-line maintenance therapy for advanced small-cell lung cancer, demonstrated no survival benefit at a pre-planned interim analysis for patients receiving Rova-T as compared with placebo.
(Alliance News) - AstraZeneca PLC on Thursday said interim analysis of its Caspian trial of Imfinzi showed the drug improved overall survival in extensive-stage small cell lung cancer.
M2 EQUITYBITES-June 18, 2019-AstraZeneca reports positive results from the interim analysis of the phase III ASCEND trial of Calquence
Global Banking News-June 18, 2019-AstraZeneca reports positive results from the interim analysis of the phase III ASCEND trial of Calquence
M2 PHARMA-June 18, 2019-AstraZeneca reports positive results from the interim analysis of the phase III ASCEND trial of Calquence
Mallinckrodt Pharmaceuticals, a leading global specialty pharmaceutical company, announced interim analysis results of its company-sponsored, Phase 3, single-arm, open-label, multi-center study assessing the efficacy of treating steroid-refractory, acute Graft-versus-Host Disease (aGvHD) pediatric patients with UVADEX (methoxsalen) Sterile Solution in conjunction with the THERAKOS CELLEX Photopheresis system.
Reportedly, TRC's decision is based on an interim analysis of the blinded data for the first 50 patients enrolled.
In line with best practice for blinded Phase 3 clinical trials, the interim analysis data are only reviewed by the IDMC.
Biogen and Ionis Pharmaceuticals' Phase III study evaluating SPINRAZA (nusinersen), an investigational treatment for spinal muscular atrophy (SMA), met the primary endpoint at the interim analysis. The analysis found that children receiving SPINRAZA experienced a highly statistically significant improvement in motor function compared to those who did not receive treatment, and demonstrated a favorable safety profile in the study.
(SeeNews) - Feb 28, 2014 -A Belgian biotechnology firmA GalapagosA (EBR:GLPG) announced Friday its UK partnerA GlaxoSmithKlineA (LON:GSK)A had terminatedA a Phase II study with GSK2586184 in lupus upon a planned interim analysis due to the lack of efficacy.
Most IRBs do not receive outcome data or have adequate statistical expertise to perform proper interim analysis to adequately weigh the risk and benefits of the trials.
Osiris Therapeutics, Inc., Columbia, MD, announced on August 13 that its multi-center, randomized, controlled clinical trial comparing the safety and effectiveness of Grafix to standard of care in patients with chronic diabetic foot ulcers had met the pre-specified stopping rules for overwhelming efficacy as determined by the data monitoring committee during a planned interim analysis. For the primary endpoint, 62% of patients receiving Grafix had complete wound closure compared to only 21% (p < 0.0001) of patients who received conventional treatment for their wounds--a relative improvement of 191% and the largest ever reported from such a study.

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