In India, the process of a clinical trial is often lengthy and complex due to the diverse and migratory population groups. As a result, India has long relied on western data, which may not be applicable to the Indian population. The process of real-world evidence (RWE) means that India can gather data from its own ethnic groups and apply it to the betterment of clinical processes.
Real-world evidence (RWE) refers to data collected from sources other than traditional randomized clinical trials (RCTs), such as observational studies, electronic health records, and patient registries. RWE provides insights into how medical products perform in realworld settings, which is useful for evaluating the safety, effectiveness, and cost-effectiveness of healthcare intervention.
RWE differs from traditional clinical trial data in that it is collected in a real-world setting and involves a more diverse and representative population. Clinical trial data is collected in a controlled environment with specific inclusion and exclusion criteria, which may not be representative of the population as a whole.
RWE can help improve patient outcomes and healthcare decision-making in India by providing a more comprehensive understanding of how interventions work in diverse populations and settings. This can inform the development of more targeted and effective interventions, as well as support evidence-based policy decisions.
RWE challenges in India
RWE is a promising tool for healthcare research, but its effectiveness hinges on the quality of the data used. In the Indian context, there are several challenges to using RWE in healthcare, observes Amrit Singh, Co-founder and CRO at Loop Health. "These include incomplete or inaccurate data, limited availability of electronic health records, and variations in healthcare practices across different regions," he says.
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