DEFINITIONS
Real World Evidence (RWE) is the clinical evidence obtained from the analysis of Real World Data (RWD) revealing the possible risks and benefits associated with an investigational product thereby confirming or nullifying the safety and efficacy status of such investigational/medical product.
As the name implies Real World Experience uses real world data generated from routine healthcare delivery to derive the information on the potential adverse effects or effectiveness of a medical product.
Over the years, the holistic assessment of the safety and efficacy of any medical intervention has been solely dependent on controlled clinical trial which are conducted strictly on a given protocol and inclusion criteria, while clinical trial is highly efficient in providing valuable insights for regulatory decision making, it can be termed to be insufficient as it puts into consideration research conducted in an ideal condition which may not adequately represent the real world settings such as diverse healthcare settings, patient’s demography and various patient’s peculiarities in everyday practice.
The impact of real world data in taking a well-informed decision about a medical product both in regulatory approval and post market surveillance (Pharmacovigilance) is enormous. The following are some of the sources of Real World Data:
- Medical claims, billing data, and insurance data
- Electronic health records (EHRs)
- Data from product and disease registries
- Patient-generated data, including from in-home-use settings
- Data gathered from other sources that can inform on health status, such as mobile devices
BENEFITS
One major advantage of RWE is the broader representation of various interests which facilitates the understanding of how treatment works in real time scenario which further helps to take inform clinical decisions. For instance, RWE takes into cognizance the underrepresented populations such as older adults, different ethnic backgrounds etc. thereby strengthening the quality of insights provided.
Also, RWE allows for the exploration of outcomes that may not have been the primary focus of traditional trials. For example, researchers can assess real-world outcomes such as healthcare utilization, medication adherence, and patient-reported outcomes, providing a more comprehensive view of treatment benefits and challenges.
RWE studies can be used to evaluate the natural history of disease, prevalence, incidence, unmet medical need, current treatment patterns, and standard of care
CHALLENGES
Data Reliability and Relevance: Data quality, completeness, and standardization varies across different sources, requiring careful methodological approaches to ensure validity and reliability.
For example, information on clinical measures of disease severity can be lacking in healthcare insurance claims, and we need better ways of examining unstructured data in electronic health records.
Safeguarding Patient’s Privacy in accordance with Good Clinical Practice (GCP) without inhibiting data access and inspection by regulatory agencies. These challenges will require continued collaboration among a range of stakeholders including regulators, industry, academia and the clinical research community.
Additionally, issues such as confounding by indication and selection bias may influence the interpretation of RWE findings, necessitating sophisticated analytical techniques to address these concerns.
CONCLUSION
While RWE is not a substitute to the traditional clinical trial neither is it a contender with the credibility of the traditional clinical trial, It is very important to state that RWE and RWD are very useful extension of a quality clinical trial which should render any clinical trial that is devoid of it to be incomplete for regulatory decision making.