Real-world evidence (RWE) refers to data collected from real-world settings, such as routine clinical practice, electronic health records, claims databases, wearable devices, and patient registries. Harnessing RWE has gained increasing importance in clinical decision-making as it provides valuable insights into the effectiveness, safety, and utilization of medical interventions in real-world patient populations. Here are some key aspects of utilizing RWE in clinical decision-making: Supplementing Randomized Controlled Trials (RCTs): RWE can complement findings from traditional RCTs by providing a broader understanding of how interventions perform in diverse patient populations, real-world healthcare settings, and long-term follow-up. RWE can provide insights into treatment outcomes, patient adherence, comparative effectiveness, and safety profiles. Expanded Patient Populations: RCTs often have strict eligibility criteria, leading to a limited representation of the real-world patient population. RWE can include a more diverse range of patients, including those with comorbidities, different demographics, and varying treatment histories. This allows for a better understanding of how interventions work in broader patient populations. Longitudinal Data and Real-World Outcomes: RWE can capture long-term outcomes and provide insights into the effectiveness and safety of interventions over extended periods. By observing patients in their natural healthcare settings, RWE can assess real-world clinical outcomes, healthcare resource utilization, and patient-reported outcomes. Comparative Effectiveness Research: RWE enables comparative effectiveness research by comparing multiple interventions, treatment strategies, or healthcare delivery approaches in real-world settings. This helps inform clinical decision-making by evaluating the benefits and risks of different treatment options and understanding their impact on patient outcomes. Safety Surveillance and Adverse Event Monitoring: RWE can play a vital role in post-marketing surveillance by identifying and monitoring adverse events or safety signals associated with medical interventions in real-world populations. This allows for early detection and investigation of potential safety concerns, leading to timely interventions and improved patient safety. Health Economics and Outcomes Research (HEOR): RWE can be used to assess the economic impact of interventions, including cost-effectiveness, healthcare resource utilization, and budget impact. This information aids in healthcare decision-making by evaluating the value and sustainability of interventions within the healthcare system. Data Quality and Methodological Considerations: Ensuring the quality and reliability of RWE is crucial. Rigorous data collection methods, standardized data elements, and appropriate statistical methodologies should be employed. Efforts should be made to address biases, confounding factors, and data limitations inherent in rea

1. Welcome
REAL-WORLD EVIDENCE: HARNESSING DATA FOR CLINICAL DECISION-
MAKING
SHAGUFTA SHAIK
M. PHARMACY
Student ID-086/052023
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2. Content
a
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Introduction
Sources of
RWD
Generation of
RWE from RWD
Clinical Decision
making
Approved
Drugs
Advantages
Uses
Limitations
Conclusion

3. Introduction
• Real-World Evidence (RWE) is the clinical evidence about the usage and
potential benefits or risks of a medical product derived from analysis of
Real-world Data (RWD).
• Real-World Data (RWD) is data relating to patient health status and/or the
delivery of health care routinely collected from a variety of sources.
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4. Sources of RWD
RWD can be accessed from various sources as
mentioned below:
 Claims
• Medical claims.
• Prescription drug claims.
• State Medicaid.
• Insurance companies.
 Clinical studies
• Clinical trial data
• Product registry.
• Disease registry.
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 Clinical setting
• EHR from clinicians/hospitals.
• Laboratory test.
• Billing data.
 Pharmacy
• Sales data.
• Prescription data.
 Patient powered
• Social media.
• Patient advocacy groups/patient
communities.

5. Medical Claims: Medical claims data gives a detailed view of patient information that entails
diagnosis, treatments, and billed and paid medical bills.
Patient Registry: Patient registries are organized systems that are used to prospectively
collect, analyze, and disseminate observational data on a group of patients
with specific characteristics in common
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6. Electronic Health Record: is a collection of various medical records that get
generated during any clinical encounter or events.
Patient Data: Data collected in these systems can also be used in medical
research to assess the effectiveness of healthcare interventions in
real world observational studies.
Social Media: They can provide patient perspectives on health topics such as
adverse events, reasons for changing treatments and non-
adherence, and quality of life.
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7. Generation Of RWE From RWD
RWE is generated from high-quality data that are:¹
1. Obtained from relevant RWD sources
2. Cleaned, harmonized, and linked to fill in gaps
3. Each step of the process must be covered by
quality criteria to generate RWE.
4. RWE is generated.
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8. Clinical decision-making
• Treatment decisions often depend on the risk/benefit ratio for an individual
patient.
• Although clinical uncertainty cannot be eliminated, RWE may help fine-tune
this appraisal and promote personalized medicine tailored to the patient.
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9. Approved drugs based on RWE
• Tacrolimus, a drug used for the treatment of Pneumonia was approved in year
2013.
• Prednisolone was approved for the treatment of Multiple Sclerosis in the year
2013.
• Methotrexate, was approved in the year 2011 for the treatment of
Rheumatoid Arthritis.
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10. Advantages Of RWE
• Less time
• Less resources
• Less cost
• Data can be accessed and retrieved easily
• Side effects are less frequently seen
• RWE can accelerate the drug approval process by supporting decision making.
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11. Limitations
• Selection Bias: Real-world data is often collected as part of routine clinical
practice, leading to potential selection bias.
• Incomplete Follow-up: Long-term follow-up and outcomes data may be
limited in real-world evidence, particularly for interventions with extended
timelines or when patients are lost to follow-up.
• Privacy and Ethical Considerations: The use of real-world data raises privacy
and ethical concerns, as it involves handling and analyzing sensitive patient
information.
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12. Uses
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Use cases for RWE in the drug development cycle.²
Drug's pre-development
stages
RWE helps inform clinical
development strategies
and study planning
During Drug development
stages
RWE may inform trial
design and feasibility.
Following drug approval RWE may help fulfill post-
marketing commitments
and support label
expansions.
In clinical practice RWE may assist
personalization of
treatment.

13. Conclusion
• In conclusion, real-world evidence (RWE) has emerged as a valuable
resource in healthcare, offering insights into the effectiveness, safety,
and value of medical interventions in real-world settings.
• Harnessing real-world evidence allows us to understand how
interventions perform in diverse patient populations, capturing the
complexity and variability of routine clinical practice.
• It enables comparative effectiveness research, safety monitoring, health
economics analysis, and patient-centered outcomes research,
empowering clinicians and decision-makers with a broader
understanding of treatment options.
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14. References
• 1. Clin Pharmacol Ther. 2018 Feb; 103(2): 202–205.
• 2. Clin Pharmacol Ther. 2018 Feb; 103(2): 202–205.
• https://rwe-navigator.eu/use-real-world-evidence/sources-of-real-world-data/
• Rebecca A. Miksad, Amy P. Abernethy Harnessing the Power of Real-World
Evidence (RWE): A Checklist to Ensure Regulatory-Grade Data Quality
• Deepa Chodankar, Perspect Clin Res. 2021 Jul-Sep; 12(3): 171–174.
Published online 2021 Jul 7. doi: 10.4103/picr.picr_62_21
• Amit Dang, Pharmaceut Med. 2023; 37(1): 25–36.
Published online 2023 Jan 5. doi: 10.1007/s40290-022-00456-6
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15. Thank You!
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(India | Canada)
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