Results 21 to 30 of about 53,197 (261)

A randomised controlled trial is not a pilot trial simply because it uses a surrogate endpoint

Pilot and Feasibility Studies, 2018
Background It has been argued that true endpoints (or ‘hard’ endpoints) for clinical trials, which are meaningful to clinicians, researchers and patients alike, are limited to those that measure health status, survival and cost.
M. J. Campbell, G. A. Lancaster, S. M. Eldridge   +2 more
doaj   +1 more source

A framework for the definition and interpretation of the use of surrogate endpoints in interventional trialsResearch in context

EClinicalMedicine, 2023
Summary: Background: Interventional trials that evaluate treatment effects using surrogate endpoints have become increasingly common. This paper describes four linked empirical studies and the development of a framework for defining, interpreting and ...
Oriana Ciani, Anthony M. Manyara, Philippa Davies, Derek Stewart, Christopher J. Weir, Amber E. Young, Jane Blazeby, Nancy J. Butcher, Sylwia Bujkiewicz, An-Wen Chan, Dalia Dawoud, Martin Offringa, Mario Ouwens, Asbjørn Hróbjartssson, Alain Amstutz, Luca Bertolaccini, Vito Domenico Bruno, Declan Devane, Christina D.C.M. Faria, Peter B. Gilbert, Ray Harris, Marissa Lassere, Lucio Marinelli, Sarah Markham, John H. Powers, Yousef Rezaei, Laura Richert, Falk Schwendicke, Larisa G. Tereshchenko, Achilles Thoma, Alparslan Turan, Andrew Worrall, Robin Christensen, Gary S. Collins, Joseph S. Ross, Rod S. Taylor   +35 more
doaj   +1 more source

Debate: Are surrogate end-point studies worth the effort?

Current Controlled Trials in Cardiovascular Medicine, 2000
Surrogate end-points of cardiovascular disease can provide useful information in cross-sectional, prospective and interventional studies. They provide information on association with risk factors, natural history and factors associated with disease ...
Elkeles Robert S, Valabhji Jonathan
doaj   +1 more source

Correlation between clinical trial endpoints of marketed cancer drugs and reimbursement decisions in China

Frontiers in Public Health, 2022
ObjectiveThis study aimed to assess whether different clinical trial endpoints in pivotal trials of cancer drugs were associated with reimbursement decisions in China.Materials and methodsCancer drugs marketed before June 30th, 2021 with publicly ...
Kexin Ling, Huli Qin, Yiman Feng, Hongxi Che, Jinxi Ding, Jinxi Ding, Wei Li, Wei Li   +7 more
doaj   +1 more source

Surrogate Endpoint Evaluation: Principal Stratification Criteria and the Prentice Definition

Journal of Causal Inference, 2015
A common problem of interest within a randomized clinical trial is the evaluation of an inexpensive response endpoint as a valid surrogate endpoint for a clinical endpoint, where a chief purpose of a valid surrogate is to provide a way to make correct ...
Gilbert Peter B., Gabriel Erin E., Huang Ying, Chan Ivan S.F.   +3 more
doaj   +1 more source

Is blood pressure reduction a valid surrogate endpoint for stroke prevention? an analysis incorporating a systematic review of randomised controlled trials, a by-trial weighted errors-in-variables regression, the surrogate threshold effect (STE) and the biomarker-surrogacy (BioSurrogate) evaluation schema (BSES)

BMC Medical Research Methodology, 2012
Background Blood pressure is considered to be a leading example of a valid surrogate endpoint. The aims of this study were to (i) formally evaluate systolic and diastolic blood pressure reduction as a surrogate endpoint for stroke prevention and (ii ...
Lassere Marissa N, Johnson Kent R, Schiff Michal, Rees David   +3 more
doaj   +1 more source

An evaluation of culture results during treatment for tuberculosis as surrogate endpoints for treatment failure and relapse.

PLoS ONE, 2013
It is widely acknowledged that new regimens are urgently needed for the treatment of tuberculosis. The primary endpoint in the Phase III trials is a composite outcome of failure at the end of treatment or relapse after stopping treatment. Such trials are
Patrick P J Phillips, Katherine Fielding, Andrew J Nunn   +2 more
doaj   +1 more source

Prognostic and therapeutic implications of measurable residual disease in acute myeloid leukemia

Journal of Hematology & Oncology, 2021
Quantification of measurable residual disease (MRD) provides critical prognostic information in acute myeloid leukemia (AML). A variety of platforms exist for MRD detection, varying in their sensitivity and applicability to individual patients.
Marisa J. L. Aitken, Farhad Ravandi, Keyur P. Patel, Nicholas J. Short   +3 more
doaj   +1 more source

Comparing Biomarkers as Principal Surrogate Endpoints [PDF]

Biometrics, 2011
Recently a new definition of surrogate endpoint, the "principal surrogate," was proposed based on causal associations between treatment effects on the biomarker and on the clinical endpoint. Despite its appealing interpretation, limited research has been conducted to evaluate principal surrogates, and existing methods focus on risk models that consider
Huang, Ying, Gilbert, Peter B.
openaire   +3 more sources

Safety of Daprodustat for the Treatment of Chronic Kidney Disease Anemia: Final Analysis of a Multicenter Postmarketing Surveillance Study in Japan

Therapeutic Apheresis and Dialysis, EarlyView.
ABSTRACT Introduction This final analysis of a multicenter, prospective postmarketing surveillance study evaluated the safety of daprodustat in patients with chronic kidney disease anemia in routine clinical practice in Japan. Methods Patients who initiated daprodustat between September 2020 and July 2022 were registered.
Tadao Akizawa, Kyomi Kanaya, Kiyomi Aizawa, Masanori Onoki, Hirofumi Ozeki, Kazuko Suzuki, Ai Hayashi, Tomohiko Asamura   +7 more
wiley   +1 more source