Real-world evidence and precision medicine represent complementary forces reshaping the healthcare landscape. The synergy between these realms offers a pathway to more personalized, effective, and patient-centered care. As technology, data analytics, and collaborative initiatives advance, the integration of real-world evidence into precision medicine practices holds the promise of revolutionizing how healthcare is delivered, ensuring that treatments are not only scientifically sound but also tailored to the unique characteristics and experiences of individual patients.

1. Welcome
REAL WORLD EVIDENCE AND PRECISION MEDICINE-
BRIDGING THE GAP
Student’s Name: A. V. Padmaja
Student’s Qualification: Pharm.D
Student ID: 239/122023
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2. Index
 INTRODUCTION
 Real world evidence
 Precision medicine
 Benefits of real world evidence and precision medicine
 Challenges in real world evidence and precision medicine
 Strategies and consideration in bridging the gap
 Conclusion
 References
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3. INTRODUCTION
Real world evidence:
Real world evidence is the data and evidence derived from real world
settings, outside the controlled environment of clinical trials.
Real world evidence is clinical evidence on a medical products safety and
efficacy that is generated using real world data resulting from routine health
care delivery.
Real World Data:
Data that come from sources other than traditional clinical trials and are
becoming increasingly important to today’s health care decisions.
It is a raw data collected from Electronic Health Records, claims databases,
patient-generalized data, disease registries.
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4. Precision medicine:
• Precision medicine sometimes known as personalized medicine is an innovative approach to tailoring
disease prevention and treatment that considers differences in people’s genes, environments and
lifestyles.
• The goal of precision medicine is to target the right treatments to the right patients at the right time.
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5. BENEFITS
Real World Evidence:
 It includes a diverse population, reflecting demographics, comorbidities and other factors often underrepresented in
clinical trials.
 It allows continuous monitoring of interventions, providing timely insights into their real-world impact.
 Examining the long-term effects and safety of treatments beyond the duration of traditional clinical trials.
Precision medicine:
 Maximize treatment effectiveness by tailoring interventions to the specific characteristics of each patient.
 Understanding how individuals metabolize the drugs and respond to treatment - decrease adverse effects and
increase safety.
 Early detection of disease risks often before the symptoms appear.
 Advancements in rare genetic disorders, where identifying specific genetic mutations is crucial for effective
management.
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6. CHALLENGES
Real world evidence:
 Ensuring quality data from diverse sources can be challenging.
 Addressing biases and confounding varieties in real world data to draw valid conclusions.
 Lack of standard data across different health care systems.
 Protecting patient privacy while utilizing EHRD.
Precision medicine:
 Safeguarding the privacy and security of sensitive genomic and health data.
 Incorporating precision medicine into routine health care practices and ensuring accessibility across diverse
population.
Addressing ethical dilemmas related to genetic testing, informed consent and potential disparities in access to
precision medicine.
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7. Strategies and considerations in bridging the gap
1. Data integration:
• EHR’s and genetic data:
Combining EHR and genomic data allows health care providers to understand the genetic makeup of individual
patients and how it may impact their response to specific treatments.
• Wearable devices and patient reported data:
Incorporating data from wearable devices and patient reported outcomes provides a more comprehensive picture of a
patient’s daily life, contributing to a better understanding of treatment effectiveness.
2. Advanced analytics and Machine learning:
• Predictive modeling:
Utilize advanced analytics and machine learning algorithm to predict patient response to treatments based on both
precision medicine and real-world evidence. This can help identify optional treatment strategies for specific patient
populations.
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8. 3. Critical trial design and patient recruitment:
Real world evidence helps to inform the design of clinical trails by identifying relevant patient populations
and recruiting suitable patients for clinical trails more efficiently on inclusion/ exclusion criteria, speeding up
the research process.
4. Multidisciplinary collaboration:
Foster collaboration among health care providers researchers, regulatory bodies, and industry stake holders.
This approach can facilitate the integration of precision medicine and real-world evidence by combining
expertise from different domains.
5. Regulatory considerations:
• Regulatory approval:
Real world evidence can support regulatory decisions by providing additional evidence on effectiveness and
safety of treatment. This is particularly important for obtaining approval for precision medicine approaches.
• Post marketing Surveillance:
RWE plays a crucial role in post marketing surveillance helping monitor long-term effectiveness and saftety
precision medicine intervention.
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9. 6. Ethical and privacy considerations:
• Transparent consent process:
Implement transparent and informed consent process that clearly communicate to patients how their data will be used
for both precision medicine and real-world evidence research.
• Data security measure:
Ensure robust measures of data securing and patient privacy addressing concerns related to the use of sensitive health
info in both precision medicine and RWE research.
7. Patient engagement and education:
• Educational initiatives
Ongoing education for health care providers on integration of precision medicine and RWE into clinical practice. This
includes training on interpreting genomic data and utilizing real-world evidence for treatment decision making.
8. Continuous learning and adaptation learning health systems:
Foster the development of learning health systems that continuously integrate RWE and precision medicine insights
into clinical work flows. This approach allows for continuous learning and adaptation to improve patient overcomes
overtime.
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10. CONCLUSION
By implementing these strategies, the health care community can bridge the gap between RWE and
precision medicine creating a more seamless and integrated approach to personalized health care that
reflects the complexity and diversity of patient experiences in real-world settings.
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11. REFERENCES:
• https://www.fda.gov/medical-devices/in-vitro-
diagnostics/precision-medicine
• https://karger.com/phg/article/22/1-2/16/321969
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12. Thank You!
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