Real World Evidence 101

Priya Kumar
2 hours ago
3 min read

Real world evidence (RWE) is transforming the current healthcare landscape. By the use of

robust data analytics tools, data collected through routine clinical practice is converted into RWE. The insights and evidence generated are valuable in guiding healthcare decision making for better patient outcomes.

What is Real World Data?

Real World Data (RWD) is all patient data collected in everyday clinical practice through a variety of sources. The U.S. Food and Drug Administration (FDA) defines RWD as " data relating to patient health status and/or the delivery of healthcare routinely collected from a variety of sources such as electronic health records (EHR), medical claims data, data from product or disease registries, and data collected from other sources such as digital health technologies".

How is RWD collected?

Real World Data is collected through a variety of sources. These sources include:

Healthcare Databases: Data collected by healthcare practitioners on a day to day basis in clinical practice contributes significantly to RWD. These are collected and entered as EHRs. The analysis of EHRs can give information about the safety and efficacy of a drug and general disease progression through patient reported outcomes.
Registries: Registries are another source of RWD and include disease registries which focus on data collected from a population with a particular disease or product registries which focus on data collected from a population using a specific product (treatments or devices). Through an organized system of collection and analysis of patient data in real world clinical setting, the registries aim to help better understand and improve patient outcomes.
Claims and Billing Data: Claims and billing data collected during inpatient, outpatient, and emergency room visits are another source of RWD. It also includes data collected on services received such as surgeries, laboratory tests, hospital stays, and pharmacy services. In the U.S., Medicare and Medicaid are the primary sources of non-commercial health claims data.
Other Sources: These include patient data on social media (e.g. Facebook), online forums, messaging boards, and patient platforms such as PatientsLikeMe. These platforms provide information on patient perspectives on various health topics including treatments received or changed, adverse events, non-adherence to medication and quality of life.

What is RWE?

RWE is generated through robust data analysis tools combined with a thorough knowledge and understanding of the sources of RWD. The U.S. FDA defines RWE as " the clinical evidence about the usage and potential benefits or risks of the usage of a medical product generated through the analysis of RWD".

How is RWE used?

RWE has been increasingly used by pharmaceutical companies and medical device companies to complement traditional clinical trials. Traditional clinical trials are hard to extrapolate to a more broader general population due to strict inclusion and exclusion criteria. RWE helps overcome the limitations of traditional clinical trials by helping clinicians, researchers, and pharmaceutical companies better understand how their products work in a real world setting. Researchers can use RWD to perform observational (non-interventional), prospective (fresh data collected) and retrospective (data already collected and analyzed) studies to better understand current technologies and therapies. Additionally, RWE can be used by healthcare systems to access quality and track outcomes.

What is the importance of RWE?

RWE bridges the gap between what is expected to happen and what really happens during routine clinical practice to drive better patient outcomes. It gives us valuable insight when a non homogeneous patient population is treated in everyday clinical practice in a real world setting.

Challenges and Future Direction

The biggest challenge RWE faces is the diversity, credibility and heterogeneity in RWD sources. In the future, building trust and transparency in the RWD collection and analysis as well as complimenting RWE with traditional clinical trails to inform real world healthcare decision making will be paramount for better patient outcomes.

References:

Assessed and Endorsed by the MedReport Medical Review Board