Real-world evidence (RWE) is considered the medical parallel of big data. Drugs represent roughly 10 percent of the cost of U.S. healthcare which projects to $328.6 billion annually. A significant amount from their revenue, $76 billion is spent on global R&D. RWE is as essential for any pharma company as their R&D. Real world evidence can not only provide valuable insights from drug usage and therapies, but also increase revenue stream by aiding the company’s R&D.
We observe an exponential growth of real world evidence in the pharma industry. CEO of Roche Pharmaceuticals, Daniel O’Day quoted to PM live, “regulatory-grade real-world evidence is a key ingredient to accelerate the development of, and access to, new cancer treatments”. Often pharma companies get disheartened when someone else is writing their “story” but they are failing to understand the importance and value of real world evidence. Results of therapies on actual patients truly differ when comparing countries, regions, patient genetics and physicians who are treating them. The era of traditional market research has ended for life sciences industry. With the evolution of technology, we can now have access to continuous real-world data.
The 21st Century Cures Act (Cures Act) was signed into U.S. law on December, 2016. The act is primarily designed to expedite medical product development. It emphasizes on FDA’s continuous goal to incorporate the patients perspectives while pharma companies are developing of drugs. Other legislations are being enacted around the world. While governments are showing keen interest in incorporating patients’ experience, it is crucial that pharma companies invest in real world evidence. Without RWE it is extremely difficult to gain knowledge of the true outcome and experience of the patients.
According to FDA, “we use RWE to monitor post-market safety, adverse event reporting and to make regulatory decisions.” Real world evidence significantly magnifies the patient sample data which was initially tested for therapies during the clinical trial process. Launch of the drug is no longer the end, but rather the beginning of the race. RWE demonstrates what is happening with real patients in real world after the launch of the drugs. Life science industry can utilize RWE as a significant advantage, as it allows them to gain valuable insights from actual patients from the real world rather than a small sample of patients during clinical trials.