scholarly journals Assessing safety at the end of clinical trials using system organ classes: A case and comparative study

2021 ◽  
Author(s):  
Raymond Carragher ◽  
Chris Robertson
Keyword(s):  
Clinical Trials ◽  
Comparative Study ◽  
System Organ

A Semi-Automated Term Harmonization Pipeline Applied to Pulmonary Arterial Hypertension Clinical Trials

2021 ◽  
Author(s):  
Ryan J. Urbanowicz ◽  
John H. Holmes ◽  
Dina Appleby ◽  
Vanamala Narasimhan ◽  
Stephen Durborow ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Pulmonary Arterial Hypertension ◽  
Arterial Hypertension ◽  
System Organ Class ◽  
High Level Group ◽  
Fuzzy Matching ◽  
Pulmonary Arterial ◽  
High Level ◽  
Level Group ◽  
System Organ

Abstract Objective Data harmonization is essential to integrate individual participant data from multiple sites, time periods, and trials for meta-analysis. The process of mapping terms and phrases to an ontology is complicated by typographic errors, abbreviations, truncation, and plurality. We sought to harmonize medical history (MH) and adverse events (AE) term records across 21 randomized clinical trials in pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension. Methods We developed and applied a semi-automated harmonization pipeline for use with domain-expert annotators to resolve ambiguous term mappings using exact and fuzzy matching. We summarized MH and AE term mapping success, including map quality measures, and imputation of a generalizing term hierarchy as defined by the applied Medical Dictionary for Regulatory Activities (MedDRA) ontology standard. Results Over 99.6% of both MH (N = 37,105) and AE (N = 58,170) records were successfully mapped to MedDRA low-level terms. Automated exact matching accounted for 74.9% of MH and 85.5% of AE mappings. Term recommendations from fuzzy matching in the pipeline facilitated annotator mapping of the remaining 24.9% of MH and 13.8% of AE records. Imputation of the generalized MedDRA term hierarchy was unambiguous in 85.2% of high-level terms, 99.4% of high-level group terms, and 99.5% of system organ class in MH, and 75% of high-level terms, 98.3% of high-level group terms, and 98.4% of system organ class in AE. Conclusion This pipeline dramatically reduced the burden of manual annotation for MH and AE term harmonization and could be adapted to other data integration efforts.

scholarly journals A comparative study between vaccines against Covid-19 in phase III clinical trials/ Um estudo comparativo entre vacinas contra Covid-19 em ensaios clínicos de fase III

2021 ◽  
Vol 4 (6) ◽  
pp. 27138-27165
Author(s):  
Carolina Dourado de Faria ◽  
Fernando Antônio Ramos Schramm Neto ◽  
Yuri de Jesus Machado ◽  
Rafael Alves dos Santos e Santos ◽  
Luna Brenda Carvalho Abade Moura Batista ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Comparative Study ◽  
Phase Iii ◽  
Phase Iii Clinical Trials

scholarly journals Informed Consent for Clinical Trials: a Comparative Study of Standard Versus Simplified Forms

1998 ◽  
Vol 90 (9) ◽  
pp. 668-674 ◽  
Author(s):  
T. C. Davis ◽  
H. J. Berkel ◽  
R. F. Holcombe ◽  
S. Pramanik ◽  
S. G. Divers
Keyword(s):  
Clinical Trials ◽  
Informed Consent ◽  
Comparative Study

scholarly journals Serious adverse events reported from the COVID-19 vaccines: A descriptive study based on WHO database

2021 ◽  
Author(s):  
Siddhartha Dutta ◽  
Rimple Jeet Kaur ◽  
Jaykaran Charan ◽  
Pankaj Bhardwaj ◽  
Praveen Sharma ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Adverse Events ◽  
Age Groups ◽  
Descriptive Study ◽  
Causality Analysis ◽  
Limited Data ◽  
Serious Adverse Events ◽  
Short Period ◽  
The Individual ◽  
System Organ

Background: In the light of the current pandemic, the emergency approval of few COVID-19 vaccines seems to provide a ray of hope. However, their approval is solely based on limited data available from the clinical trials in a short period of time; thereby imposing a necessity to study the adverse events (AEs) associated with their use. This study therefore aims to assess the Serious Adverse Events (SAEs) associated with various COVID 19 vaccines reported in the WHO database (VigiBase). Methods: The data from VigiBase was analyzed to assess the reported SAEs linked to various COVID 19 vaccines. The duplicates in the data were removed and were analyzed on the basis of age, gender, and seriousness of adverse events at the System Organ Classification (SOC) level and the individual Preferred Term (PT) level. Results: A total 103954 adverse events reported from 32044 subjects were taken for analysis. Of 32044 subjects, majority were females (80%). Also, a total of 28799 (27.7%) SAEs were reported from the 8007 individuals. Most of the SAEs were reported from Europe (83%), amongst females (79.4%) and between 18 to 64 years (80.74%) of age. Majority of SAEs (74%) were reported for BNT162b2 (Pfizer) vaccine. On system wise classification, general disorders (30%) were the commonest followed by nervous system (19.1%) and musculoskeletal (11.2%) disorders. In individual category, headache (8.1%) was the commonest, followed by pyrexia (7%) and fatigue (5.1%). The number of SAEs were reported with various vaccines were comparatively lesser as compared to the non-serious ones and incidence of death was low with all the vaccines candidates. Elderly (> 65 years) people reported more serious SAEs as compared to other age groups. Conclusion: The reported SAEs from the COVID 19 vaccines were in line with the data published in clinical trials. To link these SAEs to vaccines will need causality analysis and review of individual reports.

A comparative study of mobile electronic data entry systems for clinical trials data collection

2006 ◽  
Vol 75 (10-11) ◽  
pp. 722-729 ◽  
Author(s):  
Elodia Cole ◽  
Etta D. Pisano ◽  
Gregory J. Clary ◽  
Donglin Zeng ◽  
Marcia Koomen ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Data Collection ◽  
Comparative Study ◽  
Data Entry ◽  
Electronic Data
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