HARNESSING THE POWER OF REAL-WORLD EVIDENCE IN CLINICAL RESEARCH
INTRODUCTION:
Real-world evidence (RWE) is created from real-world data (RWD) which is clinical evidence for medical products' safety and efficacy. There are many sources of real-world data, for example, electronic health records (EHR), registries, billing data, patient-generated data, mobile health applications, and wearable devices. Real-world data can be analyzed and collected from many studies which include prospective and retrospective short studies, pragmatic clinical trials, and case-control studies. After post-marketing surveillance RWE is used more widely to generate pharmacovigilance data. Randomized controlled trials and drug approval cycles are some of the applications of RWE.
WHAT IS REAL-WORLD EVIDENCE?
The real-world evidence is obtained from the real word data which is stated as the data relating to patients' health status and delivery of patient care from various sources such as electronic health records, health registries, product registries, and some other sources including mobile devices and home settings the sources used to generate the data. The data can be obtained prospectively and retrospectively with proper privacy and ethical consideration.
The real-world evidence is the clinical proof concerning the usage of medical products which is derived from the analysis of real-world data with some benefits and risks.
HOW IS RWE OBTAINED FROM RWD?
Distinct types of observational and experimental study designs help to generate RWE from
RWD.
The different types of RWE studies include registry analysis, non-observational studies, patient surveys, and claims database analysis.
Case-control studies, cohort studies, and cross-sectional studies are forms of observational studies.
RWE data can be done prospectively and retrospectively.
RWE has a common factor which is the treatment prescribed per marketing authorization, treatment guidelines, and physician discretion.
REAL-WORLD EVIDENCE USES
It is used to explore different aspects of disease and health which include epidemiology, treatment pattern, safety, treatment outcomes, quality of life, and medication adherence.
It also provides economic aspects of medical products.
Implementing the early stages of RWE results in cost savings and a short duration of clinical trials during the development process.
RWE is utilized to support the making of clinical and regulatory decisions and approval of medical products.
It helps researchers to identify relevant variables which helps in time-saving and costsaving during the collection of data.
ADVANTAGES OF RWE
It takes less time, less resources, and less cost
In RWE the data can be accessed fast and can be easily retrieved.
RWE can be used to evaluate the prevalence, iincidence, treatment pattern history of the disease, and standard of care.
It is used to support patient outcomes and health economics.
Current healthcare services can be easily understood by High-risk studies can be done easily by the RWE system
Side effects that are less frequently seen can be studied under RWE.
CONCLUSION
The importance of real-world evidence in the healthcare industry is increasing rapidly. Because of RWE harnessing there is an improvement in the safety and efficacy of the patient data. It enables comparative effective research, safety monitoring, patient-centered outcomes, drug development, and decision maker with a broad understanding of treatment options.
Harnessing real-world evidence makes us understand how interventions occur in the different patient populations there complexity and variability during clinic trials.
REFERENCES:
Pharmaceut Med. 2023; 37(1): 25–36. Published online 2023 Jan 5. Doi: 10.1007/s40290-022-00456-6
Clinical Pharmacology & Therapeutics, 103(2), 202-205 – December
2017https://doi.org/10.1002/cpt.946
December 2017Clinical Pharmacology & Therapeutics 103(2)DOI:10.1002/cpt.946
Student ID:090/052023
Qualification: Pharm.D
e-Mail ID: shaazsama@gmail.com
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