scholarly journals PMU121 APPLICATION OF REAL-WORLD DATA FROM MEDICAL BIG-DATA PLATFORM IN REAL WORLD EVIDENCE GENERATION: A PRACTICE IN POST-MARKETING RESEARCH IN CHINA

2020 ◽  
Vol 23 ◽  
pp. S256
Author(s):  
Y. Wang ◽  
Y. Xing ◽  
Y. Wu ◽  
N. Yuan ◽  
F. Wang ◽  
...  
Keyword(s):  
Big Data ◽  
Real World ◽  
Marketing Research ◽  
Real World Data ◽  
World Data ◽  
Real World Evidence ◽  
Data Platform ◽  
Post Marketing ◽  
Medical Big Data ◽  
Evidence Generation

scholarly journals PCP53 - A DIAGNOSTIC FRAMEWORK TO EVALUATE REAL-WORLD DATA SOURCES FOR REAL-WORLD EVIDENCE GENERATION

2018 ◽  
Vol 21 ◽  
pp. S89
Author(s):  
L. Denysyk ◽  
J. Doyle ◽  
R. Sood
Keyword(s):  
Real World ◽  
Data Sources ◽  
Real World Data ◽  
World Data ◽  
Real World Evidence ◽  
Diagnostic Framework ◽  
Evidence Generation

Real-World Data and Real-World Evidence

2020 ◽  
pp. 141-166
Author(s):  
Shein-Chung Chow
Keyword(s):  
Real World ◽  
Real World Data ◽  
World Data ◽  
Real World Evidence

scholarly journals Real-world Data for Clinical Evidence Generation in Oncology

2017 ◽  
Vol 109 (11) ◽  
Author(s):  
Sean Khozin ◽  
Gideon M Blumenthal ◽  
Richard Pazdur
Keyword(s):  
Real World ◽  
Clinical Evidence ◽  
Real World Data ◽  
World Data ◽  
Evidence Generation

scholarly journals Development of an Innovative Real-World Evidence Registry for the Herpes Simplex Virus: Case Study

10.2196/16933 ◽  
2020 ◽  
Vol 3 (1) ◽  
pp. e16933 ◽  
Author(s):  
Michelle Helena van Velthoven ◽  
Ching Lam ◽  
Caroline de Cock ◽  
Terese Stenfors ◽  
Hassan Chaudhury ◽  
...  
Keyword(s):  
Herpes Simplex Virus ◽  
Herpes Simplex ◽  
Real World ◽  
Physical Symptoms ◽  
Use Cases ◽  
Real World Data ◽  
World Data ◽  
Real World Evidence ◽  
Simplex Virus

Background Infection with the herpes simplex virus (HSV) is common but not well understood. Furthermore, there remains a social stigma surrounding HSV that can have psychosocial implications for those infected. Despite many patients infected with HSV experiencing mild-to-severe physical symptoms, only one subeffective treatment is available. A registry collecting real-world data reported by individuals potentially infected with HSV could help patients to better understand and manage their condition. Objective This study aimed to report on the development of a registry to collect real-world data reported by people who might be infected with HSV. Methods A case study design was selected as it provides a systematic and in-depth approach to investigating the planning phase of the registry. The case study followed seven stages: plan, design, prepare, collect, analyze, create, and share. We carried out semistructured interviews with experts, which were thematically analyzed and used to build use cases for the proposed registry. These use cases will be used to generate detailed models of how a real-world evidence registry might be perceived and used by different users. Results The following key themes were identified in the interviews: (1) stigma and anonymity, (2) selection bias, (3) understanding treatment and outcome gaps, (4) lifestyle factors, (5) individualized versus population-level data, and (6) severe complications of HSV. We developed use cases for different types of users of the registry, including individuals with HSV, members of the public, researchers, and clinicians. Conclusions This case study revealed key considerations and insights for the development of an appropriate registry to collect real-world data reported by people who might be infected with HSV. Further development and testing of the registry with different users is required. The registry must also be evaluated for the feasibility and effectiveness of collecting data to support symptom management. This registry has the potential to contribute to the development of vaccines and treatments and provide insights into the impact of HSV on other conditions.

Current Status and Examples of US FDA or EMA’s Regulatory Decision using Real World Data/Real World Evidence

Yakhak Hoeji ◽  
2020 ◽  
Vol 64 (2) ◽  
pp. 136-155
Author(s):  
Hi Gin Sung ◽  
Han-Heui Park ◽  
Gyu-Won Jung ◽  
Ju-Young Shin
Keyword(s):  
Real World ◽  
Current Status ◽  
Real World Data ◽  
World Data ◽  
Regulatory Decision ◽  
Real World Evidence ◽  
Us Fda

Real-World Evidence and Real-World Data for Evaluating Drug Safety and Effectiveness

JAMA ◽  
2018 ◽  
Vol 320 (9) ◽  
pp. 867 ◽  
Author(s):  
Jacqueline Corrigan-Curay ◽  
Leonard Sacks ◽  
Janet Woodcock
Keyword(s):  
Drug Safety ◽  
Real World ◽  
Real World Data ◽  
World Data ◽  
Real World Evidence

scholarly journals Mobile apps for real-world evidence in health care

2020 ◽  
Vol 27 (6) ◽  
pp. 976-980
Author(s):  
Madison Milne-Ives ◽  
Michelle Helena van Velthoven ◽  
Edward Meinert
Keyword(s):  
Health Care ◽  
Mobile Health ◽  
Real World ◽  
Patient Empowerment ◽  
Real World Data ◽  
Privacy And Security ◽  
World Data ◽  
Health Apps ◽  
Real World Evidence ◽  
Mobile Health Apps

Abstract The use of real-world evidence for health care research and evaluation is growing. Mobile health apps have often-overlooked potential to contribute valuable real-world data that are not captured by other sources and could provide data that are more cost-effective and generalizable than can randomized controlled trials. However, there are several challenges that must be overcome to realize the potential value of patient-used mobile health app real-world data, including data quality, motivation for long-term use, privacy and security, methods of analysis, and standardization and integration. Addressing these challenges will increase the value of data from mobile health apps to inform real-world evidence and improve patient empowerment, clinical management, disease research, and treatment development.

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