Interim Analysis
Approaches to interim analysis of cancer randomised clinical trials with time to event endpoints: A survey from the Italian National Monitoring Centre for Clinical Trials
... Formal interim analysis offers several advantages, since this approach makes the process of acquiring and dissem- inating results more efficient and a beneficial treatment can be made available ...an ...
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An internal pilot study with interim analysis for Gaussian linear models
... the interim stage rather than half of the initial fixed sample ...the interim analysis, and by if the test statistic or critical value is modified to preserve the type I error ...
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A systematic review of the reporting of Data Monitoring Committees' roles, interim analysis and early termination in pediatric clinical trials
... Two searches were performed by one of the authors (R.F.). A Medline abstract search was used to identify the total number of pediatric trials for each journal, in order to obtain a denominator for frequency calculations. ...
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Real world effectiveness of abatacept for rheumatoid arthritis treatment in European and Canadian populations: a 6 month interim analysis of the 2 year, observational, prospective ACTION study
... This interim analysis was also vulnerable to missing data as none of the study assessments were mandatory; thus, most missing clinical outcome data may have been attributed to assessments not performed ...
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ATR-101, a selective ACAT1 inhibitor, decreases ACTH-stimulated cortisol concentrations in dogs with naturally occurring Cushing’s syndrome
... Following an interim analysis in which adverse effects were not identified, the protocol was modified to extend ATR-101 treatment to assess if any additional biochemical, adrenal hormona[r] ...
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Evidence from routine clinical practice: EMPRISE provides a new perspective on CVOTs
... planned interim analysis of EMPRISE was recently published, confirming a substantial reduction in hospitalisation for heart failure with empagliflozin across a diverse patient ...
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Prevention of abdominal wound infection (PROUD trial, DRKS00000390): study protocol for a randomized controlled trial
... adaptive interim analysis is performed after the results for the primary endpoint are available for a total of 375 evaluable ...the interim analysis results in an average total sample size of ...
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A multi stage drop the losers design for multi arm clinical trials
... Multi-arm multi-stage trials can improve the efficiency of the drug development process when multiple new treatments are available for testing. A group-sequential approach can be used in order to design multi-arm ...
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Perioperative FOLFOX4 plus bevacizumab for initially unresectable advanced colorectal cancer (NAVIGATE-CRC-01)
... Results: An interim analysis was performed at the end of NAC in the 12th patient to assess the completion rate of NAC. The median follow-up time was 56 months. The characteristics of the patients were as ...
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Effects of Intracoronary Administration of Autologous Adipose Tissue Derived Stem Cells on Acute Myocardial Infarction in a Porcine Model
... An interim analysis showed that the in- tracoronary injection of fhADCs was feasible and safe, and showed a trend toward improved cardiac function and perfu- sion defects, and reduced myocardial ...
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The use of interim data and Data Monitoring Committee recommendations in randomized controlled trial reports: frequency, implications and potential sources of bias
... CAPRICORN (CArvedilol PostinfaRct survIval COntRol in LV dysfunctioN) investigated the effects of carvedilol, a beta-blocker, in patients with left ventricular dysfunction following myocardial infarction [15]. The ...
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A literature review of applied adaptive design methodology within the field of oncology in randomised controlled trials and a proposed extension to the CONSORT guidelines
... regards to the trial or treatment. Many methods such as Simon’s two-stage design, O’Brien and Fleming design, multi-arm multi-stage designs can be in- cluded within the umbrella of group sequential de- signs [11–14]. ...
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An adaptive two arm clinical trial using early endpoints to inform decision making: design for a study of sub acromial spacers for repair of rotator cuff tendon tears
... an interim analysis there will be some participants with 3-month data, some with 3- and 6-month data and some with 3-, 6- and 12-month ...If interim analyses are limited to only those partic- ipants ...
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Predicting clinical trial results based on announcements of interim analyses
... final analysis was to occur at 592 DFS events. The first interim analysis was planned after 148 DFS events (25% information), approximately 2 years after trial ...final analysis were ...
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Real world predictors of 12–month intravenous abatacept retention in patients with rheumatoid arthritis in the ACTION observational study
... The international AbataCepT In rOutiNe clinical prac- tice (ACTION) study aims to provide prospective, real- world data on abatacept retention in patients with RA and to identify predictors of abatacept retention. Three ...
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Sequential sample size re estimation in clinical trials with multiple co primary endpoints
... a large variety of possible plans as group sequential designs do. On the other hand, group sequential designs do not offer the flexibility to make data adaptive changes to the trial design during the course of the trial ...
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Targeted alpha anticancer therapies: update and future prospects
... Interim analysis of toxicity and response in phase 1 trial of systemic targeted alpha therapy for metastatic melanoma. Cancer Biol Ther[r] ...
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Interim analyses of data as they accumulate in laboratory experimentation
... the interim analysis of results as they accumulate in clinical ...conducting interim analyses and suggest that they are acting unstatis- tically, if not unethically, they react with ...the ...
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Can involved-field irradiation replace elective nodal irradiation in chemoradiotherapy for esophageal cancer? A systematic review and meta-analysis
... pooled analysis was to investigate whether ENI in definitive radio- therapy is more beneficial than IFI in a large group of patients with esophageal cancer ...
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Retrieval of convective available potential energy from INSAT-3D measurements: comparison with radiosonde data and their spatial–temporal variations
... November). Figure 2 shows the correlation coefficient along with the number of data points used in the analysis for the comparison between estimated CAPE from the INSAT-3D measurements, ERA-Interim CAPE, ...
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