PHP328 - REAL-WORLD-DATA AND REAL-WORLD-EVIDENCE STATE OF ART FROM A LITERATURE REVIEW PERSPECTIVE

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.

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

Yakhak Hoeji ◽

10.17480/psk.2020.64.2.136 ◽

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

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

JAMA ◽

10.1001/jama.2018.10136 ◽

2018 ◽

Vol 320 (9) ◽

pp. 867 ◽

Cited By ~ 80

Author(s):

Jacqueline Corrigan-Curay ◽

Leonard Sacks ◽

Janet Woodcock

Keyword(s):

Drug Safety ◽

Real World ◽

Real World Data ◽

World Data ◽

Real World Evidence

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

Value in Health ◽

10.1016/j.jval.2020.04.885 ◽

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

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Mobile apps for real-world evidence in health care

Journal of the American Medical Informatics Association ◽

10.1093/jamia/ocaa036 ◽

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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Harnessing of real-world data and real-world evidence using digital tools: utility and potential models in rheumatology practice

Rheumatology ◽

10.1093/rheumatology/keab674 ◽

2021 ◽

Author(s):

Suchitra Kataria ◽

Vinod Ravindran

Keyword(s):

Real World ◽

Digital Tools ◽

Real World Data ◽

Disease Evolution ◽

World Data ◽

Non Invasive ◽

Real World Evidence ◽

Care Models ◽

Treatment Responses ◽

And Performance

Abstract The diversity of diseases in rheumatology and variability in disease prevalence necessitates greater data parity in disease presentation, treatment responses including adverse events to drugs and various comorbidities. Randomized controlled trials are the gold standard for drug development and performance evaluation. However, when the drug is applied outside the controlled environment, the outcomes may differ in patient populations. In this context, the need to understand the macro and micro changes involved in disease evolution and progression becomes important and so is the need for harvesting and harnessing the real-world data from various resources to use them in generating real-world evidence. Digital tools with potential relevance to rheumatology can potentially be leveraged to obtain greater patient insights, greater information on disease progression and disease micro processes and even in the early diagnosis of diseases. Since the patients spend only a minuscule portion of their time in hospital or in a clinic, using modern digital tools to generate realistic, bias-proof, real-world data in a non-invasive patient-friendly manner becomes critical. In this review we have appraised different digital mediums and mechanisms for collecting real-world data and proposed digital care models for generating real-world evidence in rheumatology.

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