Results 11 to 20 of about 583,827 (328)

Cardiovascular MRI in clinical trials: expanded applications through novel surrogate endpoints [PDF]

open access: hybrid, 2011
Recent advances in cardiovascular magnetic resonance (CMR) now allow the accurate and reproducible measurement of many aspects of cardiac and vascular structure and function, with prognostic data emerging for several key imaging biomarkers.
Ashby, D   +3 more
core   +4 more sources

Food and Drug Administration approvals in phase 3 Cancer clinical trials

open access: yesBMC Cancer, 2021
Background Phase 3 oncologic randomized clinical trials (RCTs) can lead to Food and Drug Administration (FDA) approvals. In this study, we aim to identify trial-related factors associated with trials leading to subsequent FDA drug approvals.
Joseph Abi Jaoude   +13 more
doaj   +1 more source

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

open access: yesFrontiers 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   +7 more
doaj   +1 more source

Value of Adaptive Trials and Surrogate Endpoints for Clinical Decision-Making in Rare Cancers

open access: yesFrontiers in Oncology, 2021
Despite high-level endorsement, the number of adaptive Phase II/III trials in rare cancers needs to be improved, with better understanding of their value for clinical decisions in daily practice.
Andriy Krendyukov   +2 more
doaj   +1 more source

Design and rationale of a multi-center, pragmatic, open-label randomized trial of antimicrobial therapy - the study of clinical efficacy of antimicrobial therapy strategy using pragmatic design in Idiopathic Pulmonary Fibrosis (CleanUP-IPF) clinical trial [PDF]

open access: yes, 2020
Compelling data have linked disease progression in patients with idiopathic pulmonary fibrosis (IPF) with lung dysbiosis and the resulting dysregulated local and systemic immune response.
A Mishra   +43 more
core   +1 more source

Selecting the primary endpoint in a randomized clinical trial: the ARE method [PDF]

open access: yes, 2016
The decision on the primary endpoint in a randomized clinical trial is of paramount importance and the combination of several endpoints might be a reasonable choice. Gómez and Lagakos (2013) have developed a method that quantifies how much more efficient
Gómez Melis, Guadalupe   +1 more
core   +2 more sources

Searching for potential surrogate endpoints of overall survival in clinical trials for patients with prostate cancer

open access: yesCancer Reports, 2021
Background The purpose of this study was to investigate the correlation between overall survival (OS) and other clinical outcomes in patients with prostate cancer. Further, we conducted subgroup analysis in the correlation of OS.
Hideki Maeda   +3 more
doaj   +1 more source

Complexity of design in early phase respiratory clinical trials; evaluating impact of primary endpoints and sponsor size

open access: yesContemporary Clinical Trials Communications, 2021
Asthma and COPD represent most of the clinical trials in the respiratory area. The Primary Endpoint (PE) defines how trials are conducted. We hypothesised that small and mid-sized pharmaceutical companies may be innovative in the selection of their trial
Nicolas Marco-Ariño   +3 more
doaj   +1 more source

An Integrated TCGA Pan-Cancer Clinical Data Resource to Drive High-Quality Survival Outcome Analytics [PDF]

open access: yes, 2018
For a decade, The Cancer Genome Atlas (TCGA) program collected clinicopathologic annotation data along with multi-platform molecular profiles of more than 11,000 human tumors across 33 different cancer types.
A. Abeshouse   +740 more
core   +2 more sources

Design of a real-world, prospective, longitudinal, observational study to compare vortioxetine with other standard of care antidepressant treatments in patients with major depressive disorder: a PatientsLikeMe survey

open access: yesBMC Psychiatry, 2023
Background Major depressive disorder (MDD) is a recurrent psychiatric condition that presents challenges in responding to treatment and achieving long-term remission.
Subhara Raveendran   +11 more
doaj   +1 more source

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