Real-world evidence is clinical evidence derived from real-world data. It includes information regarding medical therapy’s use, benefits and risks. This is gathered by inspecting data from several types of sources of research. These may include prospective or retrospective observational studies, large simple trials, randomized trials and pragmatic trials. RWE is used in the healthcare system, for example, in physician’s offices, for life science research, health plans and payers, policymakers and regulators.
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Life science research
Life science researchers and biopharmaceutical organizations are important stakeholders in real-world evidence, which complements the findings of traditional randomized control trials. RWE is crucial for life science researchers as it can provide them with additional insights into the impact of a medicine’s use in routine clinical care, including the safety and efficacy of new therapies.
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Policy makers and regulators
Real-world data and evidence can help policy regulators monitor post-market safety or adverse events of a drug and help in FDA decision-making. RWE can impact medication approvals and increase the rate of the drug development process. Thus, many organizations use RWE to make value-based contracts and get advanced models assessed for Medicare and state Medicaid programs.
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Health plans and payers
Realizing the value of real-world evidence, the value spectrum payers perceive informed safety monitoring, cost analysis and utilization management. While it varies, some organizations see benefit in utilizing RWE studies to inform pharmacy and therapeutic (P&T) committee decisions.
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Physicians and healthcare providers
Clinicians use RWE indirectly as they use clinical guidelines derived from it. The findings generated by it can help in understanding a disease and making data-driven treatment decisions. Real-world evidence can complement findings as it adds perspective to the results of RCTs. This empowers physicians to make targeted treatment plans.
Real-World Evidence lets researchers examine drug treatments, and its generation is more cost-effective and quicker than standard RCTs. Taking real-world evidence forward, connected health can be used to enhance its capabilities to understand what works for different types of patients. A connected healthcare device and service is designed to store health-related data so that patients can receive personalized and initiative-taking care.