Real World Evidence
&
Patient Reported Outcomes
What is Real World Evidence (RWE)?
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Real-world evidence (RWE) is evidence about the use, safety, and effectiveness of a medical product, technology, or drug, based on or derived from analysis of data generated in a real-world healthcare setting.
Real-world data (RWD) includes information about the health of individuals, or the delivery and/or outcomes of healthcare that is collected outside of traditional clinical trials and thus reflects results within the context of the particular healthcare system.
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What are Patient-Reported Outcomes (PRO)?
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Patient-reported outcomes (PRO) include the status of a patient’s health condition or behavior that comes directly from the patient. These include patients’ reports of their health and experience with healthcare.
Patient-reported outcomes measures (PROM) are quality measures derived from outcomes reported by patients. Instruments to collect them include surveys and questionnaires, and can be collected through mobile apps or other devices.
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How is RWD generated ?
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Potential sources of RWD include:
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healthcare records
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registries of patients with certain diseases
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registries of patients treated with a specific drug or health technology
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electronic medical records
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public or private insurers
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wearable and other biosensor devices
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patients.
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RWD can be collected by patients and patient groups, physicians and other healthcare providers, regulatory agencies, governments, and pharmaceutical and other private companies. The data may vary in quality and are not always fit for the purpose of informed decision-making.
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Real-world evidence comes from the analysis of RWD. However, RWD can only serve as evidence for decision-making if it is considered to be relevant and reliable information.
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Why use RWE ?
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Real-world evidence can be used to:
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provide complementary clinical evidence on the use, benefits, and risks of medical products or technologies to fill gaps in evidence from clinical trials
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evaluate the effects of clinical interventions in specific patient populations and healthcare settings not included in clinical trials
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measure longer-term health and safety outcomes that may not be available from clinical trials
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measure trends in utilization of healthcare services and burden of disease
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provide information about the effectiveness and efficiency of health services and program performance
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provide information on how drugs and health technologies are implemented and managed in the real-world setting.
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When can RWE be helpful
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All phases of a product life-cycle can benefit from RWE:
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Future outlook
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As patients increasingly turn to social media as a means of seeking information or sharing experiences, these data offer a unique opportunity to capture patient-generated data in the real world.
The feasibility of harnessing social media data has been assisted in recent years by the evolution of advanced analytics. The ability to generate insights from these data relevant to public health has already been demonstrated with some success.
Although there are a number of exciting potential future applications of these data, privacy and governance considerations remain a fundamental concern for advancement of the field.
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We support our clients in every aspect of pharmaceutical excellence, including product strategy, process transformation and capability enhancement.
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This means harnessing available data sources, utilization of digital platforms, navigation through a changing Payer & Reimbursement landscape and collaboration with academic centers and patient organizations, in order to demonstrate value to decision-making audiences.
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In addition, by focusing on emerging new technologies and analytics, which are driving change throughout the pharma industry value chain, we will support you strengthen your competitive position to better meet the changing needs of your audiences.