Health-care is an essential factor in human lives. Every hospital, pharmaceutical industry, health care professionals and all other medical related components are constantly looking to improve healthcare and provide the best patient experience. The healthcare system now focuses on being patient centric and this changing trend requires solid framework from RWE. Real-world evidence (RWE) and real-world data (RWD) has rather become a necessity for pharma companies. Traditional market research can no longer provide the data which can satisfy the required needs.
Real-world evidence (RWE) is the medical equivalent of big data. It makes use of very large data sets to determine how new drugs perform beyond the scope of clinical trials. RWE allows pharma companies to integrate data from multiple sources. Analyzing this data can provide valuable insights to pharma companies. Drugs represent roughly 10 percent of the cost of U.S. healthcare or around $328.6 billion annually. A significant amount from their revenue is spent on global R&D, $76 billion. RWE is as essential for a 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.
The global market for real world evidence is growing exponentially. Not only in U.S. but the use of RWE has a positive impact globally. Drug manufacturers are willing to pay the amount as they understand the value of good quality real world data. The total global market for RWE is projected to reach $1.34 Billion by 2023.
Figure 2: Source PR Newswire
There is a rise 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”. Sometimes companies get disheartened by letting someone else shape their narrative, but they are failing to understand the importance and value of real world evidence. Outcomes of therapies on 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.
By 2020, there will be 225 new drugs coming to market, with about a third aimed at cancer. As such, governments and healthcare payers will continue to face enormous cost and capacity challenges. Together, these trends heightened a demand for the inclusion of Real world evidence for drug development and post-trial real market data. International Society for Pharmacoeconomics and Outcome Research has defined real-world data as everything that goes beyond the data which is normally collected during the clinical trial programs. Because, even in a randomized clinical trial (RCT), one would not receive the true data compared to the actual data from the real world. According to Forbes, “RCTs are Golden but not perfect.” Therefore, a crucial need is preeminent for drug efficacy and safety beyond clinical trial and out in the real world.
It is essential to take a step further beyond the clinical trials. During a trial, there are only specific type of patients. In real world there might be a patient who is suffering from more than one chronic condition. It is possible that a patient with prostate cancer also has heart disease and diabetes. It is crucial for pharma companies to gain knowledge of the real world outcomes of their drugs. American Society of Clinical Oncology (ASCO) exemplified the need of real world evidence for improved quality of care, during their summit earlier this year. Future medicine states, “Advances in health information technology is enabling clinical, administrative and patient-generated data on virtually every patient with cancer to be systematically collected, analyzed and shared, in near real time, to immediately impact patient care and contribute to the generation of new knowledge.” Real world evidence providers such as Medimix LiveTracker™ is a leading eco-system that is truly patient-centric, global and provide the imminent tools to life sciences industry.
Image Source: Everyday Health
Real World Evidence plays a crucial role in analyzing the safety, efficacy and effectiveness of the drugs. Previously, drug launch used to be considered as the finish line, and now, it’s just the beginning of the race. Pharmaceutical companies spend billions of dollars to manufacture a drug, they cannot afford to let nature play its course. By collecting post clinical trial information about a drug in real time, RWE helps researchers and providers to quickly identify side-effects, adverse event reporting and medication errors, thereby minimizing harm and maximizing patient experience. The data collected can also be used to improve recommendations for the best way to use the medication. RWE can not only provide data for current market structure but also new drug launches, by conducting comparison studies with previously approved medications and therapies.
The 21st Century Cures Act (Cures Act) was signed into U.S. law on December, 2016. The act is designed to expedite medical product development. The law emphasizes on FDA’s ongoing work to incorporate the perspectives of patients into the development of drugs. As the government is pushing to incorporate patients’ experience, it is essential that pharma companies invest in real world evidence. Without RWE it is extremely difficult to grasp the true outcome and experience of the patients.
Image Source: CBS News
Real World Evidence hold a great potential for filling the gaps of knowledge between the pharma companies and patients. According to leading experts in Duke University, “Evidence derived from such data can be utilized to better characterize a product’s clinical outcomes in real-world patient populations.” By analyzing large database of patient records and tracking patient experience from therapies, RWE makes it practical to identify subcategories of patients who can most benefit from a specific therapy due to their genetics, the specificity of their illness, environmental, hospital, regional and other factors. Potential side-effects and adverse event reporting can also be identified much more quickly. This aid pharma companies’ global decision-making process of targeting patients and therapies by region and other criteria.
U.S. FDA uses RWE to monitor post-market safety, adverse event reporting and to make regulatory decisions. Real world evidence significantly magnifies the initial samples which was tested for therapies during clinical trials. RWE exemplifies what is happening with real patients in real world after the launch of the drugs. For life science companies this is a serious advantage, as it allows them to gain insights from actual patients which they can use for their Research & Development.
LiveTracker™ is a pioneer in real global world evidence data. LiveTracker™ provides real-time, continuous and completely cloud based data. LiveTracker™, provides not only patient share but also drug awareness, drug adoption, future Rx, biomarker testing, patient profile, treatment sequencing, usage trends and more. After collecting real world data, it is processed through in-depth analysis and then displayed in an interactive dashboard. Any data from any patient type or country can be analyzed with just a click of a button.
Figure 3: Treatment sequencing in NSCLC from LiveTracker™
Intel CEO, Brian Krzanich said “Data is the New Oil, it’s going to change most industries across the board.” Real World Evidence is no longer an optional choice but a severe necessity for healthcare. In this evolution, pharma companies need to understand the importance in RWE and invest in it. RWE is as important as clinical trials, R&D and marketing for the pharma industry, especially in a patient-centric care which is the global trend now.