scholarly journals Validation of a quantitative systems pharmacology model of calcium homeostasis using elagolix Phase 3 clinical trial data in women with endometriosis

2021 ◽  
Author(s):  
Sven Stodtmann ◽  
Ahmed Nader ◽  
Akshanth R. Polepally ◽  
Ahmed A. Suleiman ◽  
Insa Winzenborg ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Calcium Homeostasis ◽  
Clinical Trial Data ◽  
Trial Data ◽  
Systems Pharmacology ◽  
Phase 3 ◽  
Quantitative Systems Pharmacology ◽  
Systems Pharmacology Model

Pitavastatin therapy in polymedicated patients is associated with a low risk of drug-drug interactions: analysis of real-world and phase 3 clinical trial data

2015 ◽  
Vol 53 (08) ◽  
pp. 635-646 ◽  
Author(s):  
Masahiko Gosho ◽  
Masaya Tanahashi ◽  
Neil Hounslow ◽  
Tamio Teramoto
Keyword(s):  
Clinical Trial ◽  
Drug Interactions ◽  
Real World ◽  
Clinical Trial Data ◽  
Trial Data ◽  
Low Risk ◽  
Phase 3

scholarly journals Association Between Height and Clinical Outcome in Metastatic Colorectal Cancer Patients Enrolled Onto a Randomized Phase 3 Clinical Trial: Data From the FIRE-3 Study

2018 ◽  
Vol 17 (3) ◽  
pp. 215-222.e3 ◽  
Author(s):  
Michelle McSkane ◽  
Sebastian Stintzing ◽  
Volker Heinemann ◽  
Alberto Puccini ◽  
Madiha Naseem ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Clinical Trial ◽  
Clinical Outcome ◽  
Metastatic Colorectal Cancer ◽  
Cancer Patients ◽  
Clinical Trial Data ◽  
Trial Data ◽  
Phase 3 ◽  
Colorectal Cancer Patients

A review of oncologic therapeutic phase III clinical trial literature: Exploring the reporting of clinical trial data of older patients with cancer.

2018 ◽  
Vol 36 (30_suppl) ◽  
pp. 70-70 ◽  
Author(s):  
Karlynn BrintzenhofeSzoc ◽  
Armin Shahrokni ◽  
Beverly E. Canin ◽  
Ira Russell Parker ◽  
Jessica L. Krok-Schoen ◽  
...  
Keyword(s):  
Older Adults ◽  
Clinical Trial ◽  
Clinical Oncology ◽  
Keyword Search ◽  
Clinical Trial Data ◽  
Trial Data ◽  
Phase Iii ◽  
Exclusion Criteria ◽  
Phase 3 ◽  
Journal Editors

70 Background: With demographic shifts leading to an aging cancer population, the American Society of Clinical Oncology (ASCO) has recommended that journal editors improve the reporting of clinical trial data specific to older adults. This study aimed to assess the current reporting status of clinical trial data regarding older adults with cancer. Methods: This was a review of oncologic therapeutic phase-3 clinical trial data published from 07/01/2016-06/30/2017. Based on a keyword search of EMBASE and PubMed, 929 manuscripts were identified. Removing duplicates (n = 116) and articles that did not meet this study’s cancer inclusion criteria (n = 589), a total of 224 were identified. In the pilot phase there was 85% agreement among the reviewers. Results: Thus far, 197 papers (88%), have been independently reviewed with 118 evaluated by more than one reviewer. Reviewed papers were published in 57 journals including Journal of Clinical Oncology (28, 14.2%), Lancet Oncology (25, 12.7%), and NEJM (20, 10.2%). Much of the literature focused upon the following cancer sites: Breast (33, 16.7%), Lung (27, 13.7%), Colorectal (18, 9.1%), and Prostate (12, 6.1%). 175 articles included inclusion/exclusion criteria, 32 (16.2%) had upper age exclusion criteria. Age was presented in 184 articles and data was stratified by age in 84 (42.6%). Age stratification of effectiveness and toxicity were presented in the results section in 65 (38.2%) and 21 (14.4%). Effectiveness by age was in the discussion section in 37 (18.8%) and toxicity by age in 16 (8.1%). Reviewers could not determine the proportion of study participants who were older adults in 111 articles (56.2%). In the remainder of the articles, the proportion ranged from 0% to 81%, except one in which all participants were older adults. Conclusions: A slim minority of phase-3 oncologic clinical trials included and discussed age-referenced results regarding the effectiveness and toxicity of treatments in older adults. Clinical investigators and journal editors should consider the ASCO recommendation and increase the reporting of oncologic clinical trial data specific to older adults.

Sign in / Sign up

Export Citation Format

Share Document