Trials & Tribulations of Liver Transplantation‐ are trials now prohibitive without surrogate endpoints?
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DOI: 10.1002/lt.25988
Abstract: During the past 5 decades, liver transplantation has moved from its pioneering days where success was measured in days to a point where it is viewed as a routine part of medical care. Despite this… read more here.
Keywords: surrogate endpoints; tribulations liver; transplantation trials; trials tribulations ... See more keywords
Validation of surrogate endpoints in cancer clinical trials via principal stratification with an application to a prostate cancer trial.
Sign Up to like & getrecommendations! Published in 2017 at "Statistics in medicine"
DOI: 10.1002/sim.7318
Abstract: Increasing attention has been focused on the use and validation of surrogate endpoints in cancer clinical trials. Previous literature on validation of surrogate endpoints are classified into four approaches: the proportion explained approach; the indirect… read more here.
Keywords: surrogate endpoints; surrogate; endpoints cancer; validation surrogate ... See more keywords
Immunological surrogate endpoints of COVID-2019 vaccines: the evidence we have versus the evidence we need
Sign Up to like & getrecommendations! Published in 2021 at "Signal Transduction and Targeted Therapy"
DOI: 10.1038/s41392-021-00481-y
Abstract: In response to the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) pandemic, over 200 vaccine candidates against coronavirus disease 2019 (COVID-2019) are under development and currently moving forward at an unparalleled speed. The availability of surrogate… read more here.
Keywords: covid 2019; surrogate endpoints; correlates protection; evidence ... See more keywords
Correlates of protection for inactivated enterovirus 71 vaccine: the analysis of immunological surrogate endpoints
Sign Up to like & getrecommendations! Published in 2017 at "Expert Review of Vaccines"
DOI: 10.1080/14760584.2017.1335603
Abstract: ABSTRACT Background: Inactivated Enterovirus 71 (EV71) vaccines showed significant efficacy against the diseases associated with EV71 and a neutralizing antibody (NTAb) titer of 1:16–1:32 was suggested as the correlates of the vaccine protection. This paper… read more here.
Keywords: protection; surrogate endpoints; inactivated enterovirus; vaccine ... See more keywords
Patient-reported outcome measures should not be the primary outcome in glaucoma clinical trials of disease modification
Sign Up to like & getrecommendations! Published in 2022 at "British Journal of Ophthalmology"
DOI: 10.1136/bjo-2021-320722
Abstract: In the 19th century, Sir William Osler, one of the fathers of modern medicine, stated that ‘The good physician treats the disease; the great physician treats the patient who has the disease’, indicating that, as… read more here.
Keywords: surrogate endpoints; glaucoma; outcome; endpoint ... See more keywords
Surrogate endpoints in global health research: still searching for killer apps and silver bullets?
Sign Up to like & getrecommendations! Published in 2018 at "BMJ Global Health"
DOI: 10.1136/bmjgh-2018-000755
Abstract: In clinical research, there is widespread acceptance that surrogate endpoints may not translate to long-term benefits.1–3 Clinical epidemiologists highlight the hazards of surrogate measures (eg, biomarkers, laboratory test results and short-term improvements in health) that… read more here.
Keywords: surrogate endpoints; health research; endpoints global; health ... See more keywords
Need for better reporting of trials with surrogate endpoints: SPIRIT|CONSORT-SURROGATE extensions
Sign Up to like & getrecommendations! Published in 2022 at "Journal of Epidemiology and Community Health"
DOI: 10.1136/jech-2022-219294
Abstract: Evidence for the effectiveness of health interventions should ideally come from randomised trials that assess a participant relevant final outcome (PRFO), such as health status or survival. 2 However, such trials often require large sample… read more here.
Keywords: surrogate endpoints; health; randomised trials; reporting trials ... See more keywords
Surrogate endpoints for overall survival in anti-programmed death-1 and anti-programmed death ligand 1 trials of advanced melanoma.
Sign Up to like & getrecommendations! Published in 2020 at "Journal of Clinical Oncology"
DOI: 10.1200/jco.2020.38.15_suppl.10030
Abstract: 10030Background: The mechanisms of action of anti-PD-1/PD-L1 agents are markedly distinct from those of cytotoxic agents, thus a critical issue that is under investigation is what is the optimal en... read more here.
Keywords: surrogate endpoints; anti; programmed death; endpoints overall ... See more keywords
Establishing a Public Resource for Acceptable Surrogate Endpoints to Support FDA Marketing Applications
Sign Up to like & getrecommendations! Published in 2022 at "Frontiers in Medicine"
DOI: 10.3389/fmed.2022.820990
Abstract: Following a comprehensive and coordinated effort between CBER and CDER, FDA established a table of acceptable surrogate endpoints (SEs) to support drug marketing applications. The publicly accessible SE Table was first published in 2018 as… read more here.
Keywords: surrogate endpoints; establishing public; acceptable surrogate; marketing applications ... See more keywords
A proposal to analyze the progression of non-dialytic chronic kidney disease by surrogate endpoints: introducing parametric survival models
Sign Up to like & getrecommendations! Published in 2023 at "Frontiers in Medicine"
DOI: 10.3389/fmed.2023.1029165
Abstract: Introduction Chronic kidney disease (CDK) progression studies increasingly use surrogate endpoints based on the estimated glomerular filtration rate. The clinical characteristics of these endpoints bring new challenges in comparing groups of patients, as traditional Cox… read more here.
Keywords: surrogate endpoints; chronic kidney; nephrology; kidney disease ... See more keywords
Consideration of Surrogate Endpoints for Overall Survival Associated With First-Line Immunotherapy in Extensive-Stage Small Cell Lung Cancer
Sign Up to like & getrecommendations! Published in 2021 at "Frontiers in Oncology"
DOI: 10.3389/fonc.2021.696010
Abstract: Background The combination of immune checkpoint inhibitors (ICIs) and chemotherapy is known to improve overall survival (OS) in patients with extensive-stage small cell lung cancer (ES-SCLC). ICIs have different response patterns and survival kinetics characteristics… read more here.
Keywords: line immunotherapy; surrogate endpoints; line; first line ... See more keywords