Results 81 to 90 of about 25,475 (182)

Survival analysis for AdVerse events with VarYing follow-up times (SAVVY): summary of findings and assessment of existing guidelines

Trials
Background The SAVVY project aims to improve the analyses of adverse events (AEs) in clinical trials through the use of survival techniques appropriately dealing with varying follow-up times and competing events (CEs).
Kaspar Rufibach, Jan Beyersmann, Tim Friede, Claudia Schmoor, Regina Stegherr   +4 more
doaj   +1 more source

Basic Principles for Calculating the Required Number of Participants in Clinical Trials. Part 2. Survival Analysis (Review)

Регуляторные исследования и экспертиза лекарственных средств
INTRODUCTION. Survival analysis is an important biostatistics method used in clinical trials to confirm the long-term efficacy and safety of medicinal products.
O. V. Shreder, D. V. Goryachev, V. A. Merkulov   +2 more
doaj   +1 more source

Clinical trial participation, clinical care, and patient outcomes by practice setting: a real-world database analysis of patients with Chronic Lymphocytic Leukemia or Mantle Cell Lymphoma

Hematology
Objective This study was designed to compare treatment patterns, clinical trial participation, and clinical outcomes among patients with small lymphocytic lymphoma/chronic lymphocytic leukemia (CLL) or Mantle cell lymphoma (MCL) by site of care.Methods A
Debora S. Bruno, Manoj Khanal, Xiaohong Li, Maricer P. Escalon, Katherine Winfree, Lisa M. Hess   +5 more
doaj   +1 more source

Sample size considerations for single-arm clinical trials with time-to-event endpoint using the gamma distribution

Contemporary Clinical Trials Communications
Background: Time-to-event (TTE) endpoints are evaluated as the primary endpoint in single-arm clinical trials; however, limited options are available in statistical software for sample size calculation.
Junqiang Dai, Jianghua He, Milind A. Phadnis   +2 more
doaj   +1 more source

Two‐stage randomized clinical trials with a right‐censored endpoint: Comparison of frequentist and Bayesian adaptive designs

Statistics in Medicine
Adaptive randomized clinical trials are of major interest when dealing with a time‐to‐event outcome in a prolonged observation window. No consensus exists either to define stopping boundaries or to combine values or test statistics in the terminal analysis in the case of a frequentist design and sample size adaptation.
Luana Boumendil, Sylvie Chevret, Vincent Lévy, Lucie Biard   +3 more
openaire   +3 more sources

ipcwswitch: An R package for inverse probability of censoring weighting with an application to switches in clinical trials

Computers in Biology and Medicine, 2019
In randomized clinical trials (RCT), the analysis is based on the intent-to-treat principle to avoid any selection bias in the constitution of groups. However, estimates of overall survival can be biased when significant crossover occurs because the separation of randomized groups is lost.
Graffeo, Nathalie, Latouche, Aurélien, Le Tourneau, Christophe, Chevret, Sylvie   +3 more
openaire   +5 more sources

When to stop immunotherapy for advanced melanoma: the emulated target trialsResearch in context

EClinicalMedicine
Summary: Background: Immune checkpoint inhibitors (ICIs) have demonstrated their efficacy with a 7.5-year overall survival (OS) close to 50% for advanced stages.
Mathilde Amiot, Laurent Mortier, Stéphane Dalle, Olivier Dereure, Sophie Dalac, Caroline Dutriaux, Marie-Thérèse Leccia, Eve Maubec, Jean-Philippe Arnault, Florence Brunet-Possenti, Julie De Quatrebarbes, Florence Granel-Brocard, Caroline Gaudy-Marqueste, Cecile Pages, Pierre-Emmanuel Stoebner, Philippe Saiag, Thierry Lesimple, Alain Dupuy, Delphine Legoupil, Henri Montaudié, Bastien Oriano, Celeste Lebbe, Raphael Porcher   +22 more
doaj   +1 more source

Additive-multiplicative hazards regression models for interval-censored semi-competing risks data with missing intermediate events

BMC Medical Research Methodology, 2019
Background In clinical trials and survival analysis, participants may be excluded from the study due to withdrawal, which is often referred to as lost-to-follow-up (LTF). It is natural to argue that a disease would be censored due to death; however, when
Jinheum Kim, Jayoun Kim, Seong W. Kim
doaj   +1 more source

HIV-1 RNA levels and antiretroviral drug resistance in blood and non-blood compartments from HIV-1-infected men and women enrolled in AIDS clinical trials group study A5077.

PLoS ONE, 2014
BackgroundDetectable HIV-1 in body compartments can lead to transmission and antiretroviral resistance. Although sex differences in viral shedding have been demonstrated, mechanisms and magnitude are unclear.
Rami Kantor, Daniel Bettendorf, Ronald J Bosch, Marita Mann, David Katzenstein, Susan Cu-Uvin, Richard D'Aquila, Lisa Frenkel, Susan Fiscus, Robert Coombs, ACTG A5077 Study Team   +10 more
doaj   +1 more source

The clinical effectiveness and cost-effectiveness of bortezomib and thalidomide in combination regimens with an alkylating agent and a corticosteroid for the first-line treatment of multiple myeloma: a systematic review and economic evaluation.

Health Technology Assessment, 2011
Background: Multiple myeloma (MM) is the second most common haematological cancer in the UK. MM is not curable but can be treated with a combination of supportive measures and chemotherapy that aim to extend the duration and quality of survival.
J Picot, K Cooper, J Bryant, AJ Clegg
doaj   +1 more source