Some remaining challenges regarding multiple endpoints in clinical trials.
Sign Up to like & getrecommendations! Published in 2017 at "Statistics in medicine"
DOI: 10.1002/sim.7390
Abstract: Despite recent advance in methods for handling multiple endpoints in clinical trials, some challenges remain. This paper discusses some of these challenges, including confusion surrounding the terminology used to describe the multiple endpoints, the justification… read more here.
Keywords: regarding multiple; endpoints clinical; challenges regarding; clinical trials ... See more keywords
Mixed-effects models for slope-based endpoints in clinical trials of chronic kidney disease.
Sign Up to like & getrecommendations! Published in 2019 at "Statistics in medicine"
DOI: 10.1002/sim.8282
Abstract: In March of 2018, the National Kidney Foundation, in collaboration with the US Food and Drug Administration and the European Medicines Agency, sponsored a workshop in which surrogate endpoints other than currently established event-time endpoints… read more here.
Keywords: kidney; slope based; endpoints clinical; clinical trials ... See more keywords
Design and Endpoints of Clinical Trials, Current and Future
Sign Up to like & getrecommendations! Published in 2019 at "Digestive Diseases and Sciences"
DOI: 10.1007/s10620-019-05541-6
Abstract: With the advent of several new systemic agents for the treatment of hepatocellular carcinoma and the prospect of more to come it is expected that many more clinical trials will be undertaken to establish the… read more here.
Keywords: trials current; current future; endpoints clinical; clinical trials ... See more keywords
Assessing the net financial benefits of employing digital endpoints in clinical trials
Sign Up to like & getrecommendations! Published in 2024 at "Clinical and Translational Science"
DOI: 10.1111/cts.13902
Abstract: In the last few decades, developers of new drugs, biologics, and devices have increasingly leveraged digital health technologies (DHTs) to assess clinical trial digital endpoints. To our knowledge, a comprehensive assessment of the financial net… read more here.
Keywords: value; assessing net; endpoints clinical; clinical trials ... See more keywords
Imaging endpoints for clinical trial use: a RECIST perspective
Sign Up to like & getrecommendations! Published in 2022 at "Journal for Immunotherapy of Cancer"
DOI: 10.1136/jitc-2022-005092
Abstract: Twenty years after its initial introduction, Response Evaluation Criteria in Solid Tumors (RECIST) remains today a unique standardized tool allowing uniform objective evaluation of response in solid tumors in clinical trials across different treatment indications.… read more here.
Keywords: trial use; recist; clinical trial; imaging endpoints ... See more keywords
Endpoints for Clinical Trials of Acute Kidney Injury
Sign Up to like & getrecommendations! Published in 2018 at "Nephron"
DOI: 10.1159/000493203
Abstract: Background: The selection of appropriate endpoints is critical to the success of any clinical trial. Endpoints need to be precisely defined and need to provide an appropriate balance between sensitivity for detection of the effects… read more here.
Keywords: acute kidney; endpoints clinical; clinical trials; kidney injury ... See more keywords
The Application of Continuous Glucose Monitoring Endpoints in Clinical Research: Analysis of Trends and Review of Challenges.
Sign Up to like & getrecommendations! Published in 2024 at "Journal of diabetes science and technology"
DOI: 10.1177/19322968241301800
Abstract: INTRODUCTION Considerable efforts to standardize continuous glucose monitoring (CGM) have occurred in recent years. The aim was to perform an analysis of clinical studies in clinicaltrials.gov to evaluate trends in CGM endpoint adoption. METHODS Clinicaltrials.gov… read more here.
Keywords: cgm; continuous glucose; analysis; endpoints clinical ... See more keywords