Leveraging real‐world evidence for determining performance goals for medical device studies

2021 ◽  
Author(s):  
Chenguang Wang ◽  
Gary L. Rosner ◽  
Tingting Bao ◽  
Nelson Lu ◽  
Wei‐Chen Chen ◽  
...  
Keyword(s):  
Medical Device ◽  
Real World ◽  
Performance Goals ◽  
Real World Evidence

scholarly journals Race and Ethnicity in Real-World Data Sources: Considerations for Medical Device Regulatory Efforts

2021 ◽  
Vol 12 ◽  
pp. 215013272199404
Author(s):  
Michelle E. Tarver
Keyword(s):  
Medical Device ◽  
Real World ◽  
Race And Ethnicity ◽  
Data Sources ◽  
Real World Data ◽  
Daily Lives ◽  
World Data ◽  
Medical Products ◽  
Real World Evidence ◽  
Ethnic Subgroups

Real-world evidence is increasingly being collected in our interconnected world. This information can provide insights on how medical products are impacting the daily lives of patients, translating into public health consequences. Understanding the demographic characteristics of patients contributing health information to real-world data sources is critical to determining the safety and effectiveness of medical products for specific populations. Race and ethnicity are recorded inconsistently in different real-world data sources, with many lacking reliable information on these variables. To better leverage all forms of real-world data to inform medical device evaluation, accurate and consistent collection of information from different racial and ethnic subgroups is necessary.

1243-P: Novel Use of Natural Language Processing to Identify Reasons for Insulin Discontinuation in Patients with T2DM: A Real-World Evidence Study

Diabetes ◽  
2019 ◽  
Vol 68 (Supplement 1) ◽  
pp. 1243-P
Author(s):  
JIANMIN WU ◽  
FRITHA J. MORRISON ◽  
ZHENXIANG ZHAO ◽  
XUANYAO HE ◽  
MARIA SHUBINA ◽  
...  
Keyword(s):  
Natural Language Processing ◽  
Natural Language ◽  
Language Processing ◽  
Real World ◽  
Real World Evidence

381-P: Real-World Evidence that Impaired Awareness of Hypoglycemia Increases Severe Hypoglycemia Rates in T2DM (InHypo-DM Study)

Diabetes ◽  
2019 ◽  
Vol 68 (Supplement 1) ◽  
pp. 381-P
Author(s):  
ALEXANDRIA RATZKI-LEEWING ◽  
STEWART B. HARRIS ◽  
NATALIE H. AU ◽  
SUSAN WEBSTER-BOGAERT ◽  
JUDITH B. BROWN ◽  
...  
Keyword(s):  
Real World ◽  
Severe Hypoglycemia ◽  
Real World Evidence ◽  
Impaired Awareness

1607-P: Real-World Evidence of the Impact of Obesity on Residual Teeth in the Japanese Population

Diabetes ◽  
2020 ◽  
Vol 69 (Supplement 1) ◽  
pp. 1607-P
Author(s):  
MAYU HAYASHI ◽  
KATSUTARO MORINO ◽  
KAYO HARADA ◽  
MIKI ISHIKAWA ◽  
ITSUKO MIYAZAWA ◽  
...  
Keyword(s):  
Real World ◽  
Japanese Population ◽  
Real World Evidence ◽  
The Impact
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