Health outcomes research aims to assess the real-world effectiveness, safety, and value of healthcare interventions. In recent years, the availability and utilization of real-world data (RWD) have significantly contributed to advancing health outcomes research. This paper explores the various sources of real-world data and their applications in health outcomes research. Real-world data refers to data collected outside of controlled clinical trials, often generated through routine healthcare delivery, electronic health records (EHRs), claims databases, registries, wearable devices, and patient-reported outcomes. These data sources provide a wealth of information on patient characteristics, treatment patterns, healthcare utilization, and clinical outcomes in real-world settings.

1. Welcome
REAL WORLD DATA SOURCES AND APPLICATIONS IN
HEALTH OUTCOMES RESEARCH
A. Shireesha
MSc. Biotechnology
0100/052023
10/18/2022
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2. INDEX :
 What is Real world data [ RWD ] ?
 Sources of Real world data
 Application in health outcomes research
 Expected health outcomes using RWD
 Conclusion
 References
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3. WHAT IS REAL WORLD DATA ?
• RWD is the Data relating to patient health
status and/or the delivery of health care
routinely collected from a variety of sources.
• RWE ( Real World Evidence) is the clinical
evidence regarding the usage and potential
benefits or risks of a medical product derived
from analysis of RWD.
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4. TYPES OF RWD :
• RWD is data that are routinely collected about patients and their health
from multiple sources outside of randomized clinical trials.
• Types of RWD include:
1. In the clinic: Electronic health records (EHRs), claims and billing, and
product and disease registries
2. Outside the clinic: Patient-generated data collected in a home setting,
through mobile devices, such as wearables, and on patient-mediated
platforms
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SOURCES OF
REAL – WORLD
DATA
CLINICAL DATA
PATIENT
GENERATED
DATA
COST AND
UTILISATION DATA
PUBLIC HEALTH
DATA
SOCIAL MEDIA
PRAGMATIC
CLINICAL TRIALS
REAL – WORLD DATA SOURCES

6. REAL –WORLD DATA SOURCES :
• Clinical data from electronic health records (EHRs) and case report forms
(eCRFs). This data provide patient demographics, family history, treatment
history, and outcomes.
• Patient-generated data from patient-reported outcome ( PRO ).
These data provide insights directly from the patient, and they help researchers
understand what happens outside of clinic visits, procedures, and hospital
stays.
• Cost and utilization data from claims and public datasets. They provide
information regarding healthcare services utilization, population coverage,
and prescribing patterns.
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• Public health data from various government data sources including
national networks and centers. These add critical information to enable
stakeholders to best serve the needs of the populations they serve.
• Pragmatic clinical trials offer the opportunity to obtain real-word data
on the relative effectiveness of a treatment in an early phase of
development, thus addressing the need for real-world evidence.
• Social media platforms such as Facebook, Twitter and patient networks
have created abundant opportunities for patients and their carers to create
and exchange health-related information.
• Patients’ health status and outcomes data from: Image data, Lab,
Molecular profiling (genetic testing), Digital biomarkers, Family history,
Long-term care.

8. REAL WORLD TYPES AND USES
Text Here.
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9. HOW WERE RWD APPLIED ?
• In new drug applications, RWD were typically used as comparative data in the clinical
study, mostly as a control group (or historical control) for tolerability and efficacy
studies.
• Examples - cerliponase alfa , cholic acid[FDA approval],tisagenlecleucel , strimvelis,
nusinersen, Zalmoxis.
• In some cases, RWD were used to characterize the biomarkers and disease
manifestations enable the identification of the appropriate patient population for the
study.
• Examples - alipogene tiparvovec, elosulfase alfa, avelumab.
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10. • A proper understanding of clinical care and its results through the use and
application of RWD is expected to improve the Quality of life of citizens and
patients who provide data while securing a sustainable social security system.
• In Europe and the United States,
RWD is increasingly used for approval applications for :
 The clinical development of drugs
 Cost-effectiveness evaluations for insurance reimbursement and
 Drug price negotiations.
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11. EXPECTED HEALTH OUTCOMES BY UTILIZATION OF RWD :
Based on RWD, the following outcomes can be expected:
 Understanding diseases in basic medical research
 Clinical development and application of drug approval
 Early detection of health risks from pharmaceuticals and medical devices.
 Streamlining and optimization of diagnosis and treatment by physicians.
 Evaluation of and responses to government medical policies.
 Improvement in patient access to healthcare.
 Improvement of quality and efficiency of health management, lifestyle, and preventive
services.
 Improvement in quality and efficiency of nursing services
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12. CONCLUSION :
• RWD provide a valuable and rich data source beyond the confines of
traditional epidemiological studies, clinical trials, and lab-based experiments,
with lower cost in data collection compared to the latter.
• If used and analyzed appropriately, RWD have the potential to generate valid
and unbiased RWE with savings in both cost and time, compared to controlled
trials, and to enhance the efficiency of medical and health-related research and
decision-making.
• Procedures that improve the quality of the data and overcome the limitation of
RWD to make the best of them have been and will continue to be developed.
• With the enthusiasm, commitment, and investment in RWD from all key
stakeholders, Lets hope that the day that RWD unleashes its full potential will
come soon.
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13. REFERENCES :
1.https://www.sciencedirect.com/science/article/pii/S0149291820301338
2. https://h1.co/blog/real-world-data-sources-and-effective-evaluation/
3.https://bmcmedicine.biomedcentral.com/articles/10.1186/s12916-018-1247-8
4. https://www.chuga
pharm.co.jp/english/profile/digital/real_world_data.html#:~:text=RWD%20enc
ompasses%20data%20collected%20from,patient%20registries%2C%20and%2
0wearable%20devices.
5. https://www.ppd.com/blog/six-trends-influencing-real-world-evidence-
future/
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14. Thank You!
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