One of the provisions of the 21st Century Cures Act is to encourage the use of real-world evidence (RWE). RWE provides deep insights into how a drug or device is actually used and how it performs in the real world. RWE research is primarily observational with insights derived through medical records, prescriptions, registries, surveys, chart reviews, and administrative data. Life sciences organizations can benefit from RWE in three main ways.
1. Accelerate Product Development
From the causes of a disease and its progression, to genomic sequencing, and general market analysis and understanding, being able to use the data to make the decisions about a potential new product can differentiate a company from its competitors. RWE also provides a meaningful assessment of costs when developing the innovative new product. In addition, RWE can assist in forming risk-sharing agreements between manufacturers, payers, and providers based on patient outcomes.
2. Clinical Applications
While most providers have participated in some type of clinical trial focused narrowly at the effectiveness of a therapy within a homogeneous patient population in a controlled setting, RWE focuses on data from actual events. RWE helps enhance clinical practices and drive greater value around targeted medical approaches while examining how they impact both short-term and long-term patient outcomes.
For example, a real-world retrospective observational research study led by Premier and bioMerieux examined the effect of testing with the biomarker procalcitonin in thousands of U.S. patients admitted to an intensive care unit (ICU) with sepsis. Procalcitonin exhibits greater sensitivity and specificity than other markers in ruling-out and ruling-in sepsis and other serious bacterial infections. The results showed that patients in the procalcitonin testing group spent less time in the hospital (reduced length-of-stay up to 1.3 days) and reduced hospitalization cost by nearly $2,800 per patient.
3. Improve Commercial Activities
RWE can help life sciences organizations improve marketing effectiveness, competitive product analysis, and customer engagement and support. RWE can be mined, interpreted, and analyzed to provide early insights as to the marketing effectiveness for a drug or device. RWE can measure patient outcome benefits that can lead to product quality improvements. RWE also helps companies understand the type(s) of patients or providers who are using their product and how they are using it as well as how their product compares to the competition. Using RWE helps to improve operational efficiencies, which can lead to enhanced patient engagement and support.
RWE has the potential to transform the way life sciences organizations use technologies to gain deeper clinical insights to make informed decisions, enable them to accelerate the “bench to bedside” process, and allow them and payers to collaborate like never before. From a patient perspective, RWE can help generate insights to improve the cost effectiveness of care and information about how best to manage the patient journey. While the 21st Century Cures Act identified a number of challenges for life sciences, the use and adoption of RWE is helping to overcome them.