Evaluation of Safety, Tolerability, and Changes in Biomarker and Clinical Outcome Assessments of Losmapimod for FSHD1

2019 ◽  
Author(s):  
Keyword(s):  
Clinical Outcome ◽  
Outcome Assessments ◽  
Clinical Outcome Assessments

Clinical outcome assessments of motor status in patients undergoing brain tumor surgery

2021 ◽  
Vol 201 ◽  
pp. 106420
Author(s):  
Mayla Santana Correia ◽  
Iuri Santana Neville ◽  
Cesar Cimonari de Almeida ◽  
Cintya Yukie Hayashi ◽  
Luana Talita Diniz Ferreira ◽  
...  
Keyword(s):  
Brain Tumor ◽  
Clinical Outcome ◽  
Tumor Surgery ◽  
Brain Tumor Surgery ◽  
Outcome Assessments ◽  
Clinical Outcome Assessments

scholarly journals Opportunities and challenges of incorporating clinical outcome assessments in brain tumor clinical trials

2018 ◽  
Vol 6 (2) ◽  
pp. 81-92 ◽  
Author(s):  
Emanuela Molinari ◽  
Tito R Mendoza ◽  
Mark R Gilbert
Keyword(s):  
Clinical Trials ◽  
Brain Tumor ◽  
Clinical Outcome ◽  
Clinical Trial Design ◽  
Well Being ◽  
Successful Implementation ◽  
Outcome Assessments ◽  
Tumor Studies ◽  
Clinical Outcome Assessments ◽  
The Impact

Abstract Regulatory agencies have progressively emphasized the importance of assessing broader aspects of patient well-being to better define therapeutic gain. As a result, clinical outcome assessments (COAs) are increasingly used to evaluate the impact, both positive and negative, of cancer treatments and in some instances have played a major factor in the regulatory approval of drugs. Challenges remain, however, in the routine incorporation of these measures in cancer clinical trials, particularly in brain tumor studies. Factors unique to brain tumor patients such as cognitive decline and language dysfunction may hamper their successful implementation. Study designs often relegated these outcome measures to exploratory endpoints, further compromising data completion. New strategies are needed to maximize the complementary information that COAs could add to clinical trials alongside more traditional measures such as progression-free and overall survival. The routine incorporation of COAs as either primary or secondary objectives with attention to minimizing missing data should define a novel clinical trial design. We provide a review of the approaches, challenges, and opportunities for incorporating COAs into brain tumor clinical research, providing a perspective for integrating these measures into clinical trials.

scholarly journals PIH8 NOVEL MEASUREMENT STRATEGIES FOR COLLECTION OF CLINICAL OUTCOME ASSESSMENTS IN A PEDIATRIC POPULATION

2019 ◽  
Vol 22 ◽  
pp. S183-S184
Author(s):  
D. Turner-Bowker ◽  
M. Krohe ◽  
A. Yaworsky ◽  
M. Kelly ◽  
B. Padilla ◽  
...  
Keyword(s):  
Clinical Outcome ◽  
Pediatric Population ◽  
Outcome Assessments ◽  
Clinical Outcome Assessments ◽  
Measurement Strategies
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