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In many phase II trials in solid tumours, patients are assessed using endpoints based on the Response Evaluation Criteria in Solid Tumours (RECIST) scale. Often, analyses are based on the response rate. This is the proportion of...

continuous tumour shrinkage endpoints longitudinal model phase II cancer trial Clinical Trials Phase II as Topic Colonic Neoplasms Computer Simulation Disease Progression Endpoint Determination Humans Logistic Models Medical Oncology Neoplasms Randomized Controlled Trials as Topic Research Design Treatment Outcome

Multi-arm multi-stage trial designs can bring notable gains in efficiency to the drug development process. However, for normally distributed endpoints, the determination of a design typically depends on the assumption that the...

Familywise error-rate group sequential interim analyses Multi-arm multi-stage t-Statistic Analysis of Variance Clinical Trials as Topic Data Interpretation Statistical Endpoint Determination Humans Monte Carlo Method Research Design Sample Size

Alcohol Drinking Body Mass Index Cause of Death Coronary Artery Disease Dose-Response Relationship Drug Endpoint Determination Europe Exercise Female Humans Male Middle Aged Prospective Studies Risk Reduction Behavior Smoking stroke Time Factors

Genetic damage is a key event in tumorigenesis, and chemically induced genotoxic effects are a human health concern. Although genetic toxicity data have historically been interpreted using a qualitative screen-and-bin approach...

BMD Benzo[a]pyrene Clastogenicity DNA Adducts Genotoxicity Mutation Animals Benzo(a)pyrene Carcinogens environmental DNA Adducts DNA Damage Dose-Response Relationship Drug Endpoint Determination Erythrocytes Male Mice Mice Transgenic Micronucleus Tests Models Theoretical Mutagenicity Tests Toxicity Tests

BACKGROUND: Acute myeloid leukemia (AML) is the most common acute leukemia in adults and has an unacceptably low cure rate. In recent years, a number of new treatment strategies and compounds were developed for the treatment of...

acute myeloid leukemia core outcome set Delphi process Biomedical Research Consensus Delphi Technique Endpoint Determination Humans Leukemia Myeloid Acute Outcome Assessment Health Care Pilot Projects Research Design

BACKGROUND: Clinical trials and other studies commonly assess the effectiveness of an intervention through the use of responder-based endpoints. These classify patients based on whether they meet a number of criteria which often...

Augmented binary method Composite endpoint Efficiency Responder analysis statistical analysis Clinical Trials as Topic Data Interpretation Statistical Endpoint Determination Humans Outcome Assessment Health Care

BACKGROUND: Randomised controlled trials (RCTs) are used to evaluate social and psychological interventions and inform policy decisions about them. Accurate, complete, and transparent reports of social and psychological...

CONSORT randomised controlled trial Reporting guideline reporting standards Transparency Behavior Therapy Checklist Consensus Consensus Development Conferences as Topic Data Accuracy Delphi Technique Endpoint Determination Humans Outcome Assessment Health Care Randomized Controlled Trials as Topic Research Design Social Environment Treatment Outcome

Mixed outcome endpoints that combine multiple continuous and discrete components are often employed as primary outcome measures in clinical trials. These may be in the form of co-primary endpoints, which conclude effectiveness...

latent variable modeling mixed outcome endpoints sample size estimation Endpoint Determination Humans Models Statistical Neoplasms Multiple Primary Sample Size

PVI 5FU gives increased response rates and reduced toxicity when compared to bolus 5FU (J Clin Oncol 1989, 425-432). PVI 5FU administration was reported to give highly variable (>1000-fold) plasma 5FU concentrations at steady...

Adult Aged Antimetabolites Antineoplastic Colorectal Neoplasms Endpoint Determination Female Fluorouracil Humans Infusions Intravenous Male Middle Aged Survival Analysis Treatment Outcome

BACKGROUND: The CONSORT (Consolidated Standards of Reporting Trials) Statement was developed to help biomedical researchers report randomised controlled trials (RCTs) transparently. We have developed an extension to the CONSORT...

CONSORT randomised controlled trial Reporting guideline reporting standards Transparency Behavior Therapy Checklist Consensus Data Accuracy Delphi Technique Endpoint Determination Humans Outcome Assessment Health Care Randomized Controlled Trials as Topic Research Design Social Environment Treatment Outcome

Angiotensin-Converting Enzyme Inhibitors Anti-Retroviral Agents Benzimidazoles Benzoates Bias Clinical Trials as Topic Computer Simulation Drug Therapy Combination Endpoint Determination HIV Infections Humans Insulin Resistance Research Design Sample Size Telmisartan

BACKGROUND/AIMS: The stepped-wedge cluster randomised trial design has received substantial attention in recent years. Although various extensions to the original design have been proposed, no guidance is available on the design...

stepped wedge cluster randomised trial error spending group sequential interim analyses Endpoint Determination Humans Linear Models Medical Futility Patient Selection Randomized Controlled Trials as Topic Research Design Sample Size Treatment Outcome

We propose a novel response-adaptive randomization procedure for multi-armed trials with continuous outcomes that are assumed to be normally distributed. Our proposed rule is non-myopic, and oriented toward a patient benefit...

Gittins index adaptive designs continuous endpoint dichotomization missing data unknown variance Adaptive Clinical Trials as Topic Algorithms Biometry Clinical Trials Phase II as Topic Computer Simulation Endpoint Determination Humans Models Statistical Neoplasms Patient Dropouts Randomized Controlled Trials as Topic Treatment Outcome

Managing traumatic brain injury (TBI) patients with a cerebral perfusion pressure (CPP) near to the cerebral autoregulation (CA)-guided "optimal" CPP (CPPopt) value is associated with improved outcome and might be useful to...

cerebral autoregulation cerebral perfusion Intensive Care Optimal cerebral perfusion pressure Precision Medicine Traumatic brain injury Adult Aged Brain Injuries Traumatic Cerebrovascular Circulation Endpoint Determination Feasibility Studies Female Homeostasis Humans Male Middle Aged Neurophysiological Monitoring Perfusion Retrospective Studies Software Treatment Outcome

BACKGROUND: When a randomised trial is subject to deviations from randomised treatment, analysis according to intention-to-treat does not estimate two important quantities: relative treatment efficacy and effectiveness in a...

Causal effect modelling Deviation from randomised treatment Non-compliance Nonadherence Trial analysis Bias Data Interpretation Statistical Drug Substitution Endpoint Determination Guideline Adherence Humans Infant Intention to Treat Analysis Patient Compliance Practice Guidelines as Topic Randomized Controlled Trials as Topic Research Design Sample Size Treatment Outcome

BACKGROUND: In an era of low local relapse rates after adjuvant breast radiotherapy, risks of late normal-tissue effects (NTE) need to be balanced against risk of relapse. NTE are assessed using patient-reported outcome measures...

Breast Normal tissue effects PROMs Patient-reported Radiotherapy Trials Adult Breast Neoplasms Clinical Trials Phase III as Topic Combined Modality Therapy Disease Progression Endpoint Determination Female Humans Middle Aged Neoplasm Recurrence Local Patient Reported Outcome Measures Photography Radiotherapy Radiotherapy Adjuvant Randomized Controlled Trials as Topic