eal-world evidence has changed our everyday lives, whether we realize it or not. It’s a key part of making health and public safety decisions, but what exactly is it?
Real-world data (RWD) refers to the collection of data about a patient’s health status or routine healthcare delivery. According to the U.S. Food and Drug Administration (FDA), real-world evidence (RWE) is the culmination of clinical evidence regarding the usage and potential benefits or risks of a procedure or medical product derived from analysis of RWD.
As Kristin Kostka, director of the OHDSI Center at Northeastern University’s Roux Institute, puts it, “data by itself is not evidence, but evidence is comprised of data.” Real-world evidence research is the systematic process by which data can be studied to produce findings. Therefore, real-world evidence doesn’t exist without the collection of valuable and translatable data.
Read on to learn how RWE has impacted healthcare today and how you can break into this new sector of data analysis.
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Real-World Evidence and Healthcare History
Real-world data and real-world evidence are playing an increasing role in healthcare decisions, according to the FDA. The FDA uses RWD and RWE “to monitor post-market safety and adverse events to make regulatory decisions.” The data is used to help support coverage decisions and develop guidelines and decision-support tools for use in clinical practice.
In 2016, the 21st Century Cures Act was passed, which places additional focus on using these types of data “to support regulatory decision-making, including approval of new indications for approved drugs.” Since then, Congress has put more money into research over costly experiments, becoming a more active partner in research and development through budget allocation and regulatory decision-making.
Technological advancements help bring data to the forefront of healthcare decision-making.
10 Statistics About Real-World Evidence’s Impact on Healthcare
1. The President’s 2023 budget request allocated $62.5 billion to the National Institutes of Health.
The president’s 2023 budget request allocated $62.5 billion to the National Institutes of Health compared to the $42.9 billion the agency received in the 2022 continuing resolution. As mentioned above, there is a growing need for research rather than costly experiments, and the government recognizes this.
The 2023 proposal includes $12.1 billion more for pandemic preparedness and an additional $5 billion to support the new Advanced Research Project Agency for Health (ARPA-H). ARPA-H was first proposed in the president’s 2022 budget and is modeled after the Defense Advanced Research Projects Agency. It aims to use public-private partnerships for quicker support of results-driven, time-limited projects and innovations to enable more experimentation.
“ARPA-H should expect that a significant fraction of its efforts will fail; if not, the organization is being too risk-averse. The best approach is to fail early in the process by addressing key risks upfront,” the NIH wrote in its 2023 budget justification to Congress.
While this might seem expensive, the average cost of clinical trials can range from $4 to $20 million, according to the U.S. Department of Health and Human Services. In addition, new drugs approved by the FDA cost about $41,117 per patient.
2. The European Medicines Agency awarded more than €52 Million in 2022 to support RWD generation in Europe.
RWE doesn’t just connect the dots of healthcare on a national level, but it also has global implications. Regulatory bodies like the FDA and European Medicines Agency (EMA) are increasingly using real-world evidence and, in some cases, requiring it.
International health data, which will now be more easily translatable and accessible on a global scale, can help inform healthcare decisions here in the U.S., as well.
3. Ninety perecent of pharmaceutical companies have real-world evidence teams.
According to Deloitte, 90 percent of pharmaceutical companies now have real-world evidence teams, showing pharma’s interest in RWE and RWD. This interest has also led to growing opportunities for RWE professionals in the industry in roles such as real-world data managers, biostatisticians, and principal data scientists.
The U.S. has the largest number of innovative pharmaceutical companies and is accompanied by huge research and development investments. With the data boom occurring in healthcare today, RWE is paramount in supporting drug development and regulatory decision-making.
“There’s more data being captured than we ever thought humanly possible,” Kostka says.
The development of RWE in the U.S. first originated from Congress’s request to the FDA to assess the potential utilization of RWE, including supporting new indications approval and post-market research. There are many uses of real-world evidence, but perhaps the most topical is saving money in healthcare by investing in research rather than costly experiments, learning from past trends and models, and preventing possible negative health outcomes by using real-world evidence to learn from patterns of treatment of what works and what doesn’t.
4. The global real-world evidence solutions market is expected to reach USD 78.8 billion by 2030.
The global real-world evidence solutions market is expected to reach USD 78.80 billion by 2030, and the market is expected to expand at a CAGR of 8.1 percent from 2022 to 2030. Favorable government regulations and “a shift from volume to value-based care” are key factors believed to be driving the RWE solutions market.
5. Amazon Web Services (AWS) is the world’s most comprehensive cloud platform.
Amazon Web Services (AWS) offers more than 200 fully featured services from data centers globally, claiming to have the most extensive global cloud infrastructure.
Major companies, specifically in the technology sector, are now dipping their toes into providing targeted solutions to warehouse healthcare data. Technology companies like AWS are helping accelerate the way researchers analyze RWD and generate RWE.
6. Non-Hispanic Black people comprised 34% of COVID-related deaths.
It’s no secret that health outcomes are not evenly distributed across different age bands or races. Even though they constitute only 12 percent of the population, non-Hispanic Black individuals comprised 34 percent of COVID-related deaths.
Initiatives like the National Institutes of Health All of Us Program are tackling underrepresentation in health outcomes research by helping to build one of the most diverse health databases in history. More representative real-world data (RWD) can improve clinical understanding of health disparities and improve health outcomes.
7. About 1-in-5 Americans use a smartwatch or fitness tracker.
Digitizing our health data is becoming more common. For example, about 21 percent of U.S. adults say they regularly wear a fitness tracker. These trackers compile various data about the wearer’s activity that can be used for health research.
In a 2019 survey by the Pew Research Center, about 41 percent of Americans said it’s acceptable for makers of fitness trackers to share data for heart disease research. Some researchers are already using data from fitness-tracking apps for health research. Real-world data becomes richer as more data sources can be linked together to understand health trends and outcomes.
8. Less than 10% of cancer patients participate in clinical trials.
Oncology and other serious or chronic illnesses can greatly benefit from RWE because their clinical trials often don’t have enough participation. A recent study suggests the low participation rate is due to patients not having clinical trials available to them or being deemed ineligible. This shows the need to address how clinical trials are conducted.
“In these high stakes, high reward situations where we’re looking to get therapies on market for groups that have a serious need, there’s a lot of interest,” Kostka says.
Participation in these clinical trials is dire for ensuring access to new treatments and progressing research.
9. Almost 90% of office-based physicians use an EMR or EHR system.
RWE studies make use of routine clinical data, creating less burden on patients. As of 2019, nearly 90 percent of office-based physicians in the U.S. use electronic medical records or electronic health records (EMRs/EHRs).
10. The FDA’s Center for Devices and Radiological Health used RWE in pre- and post-market regulatory decisions 193% more from 2015 to 2017.
RWE is now playing a pivotal role in regulatory decision-making. In June 2017, the FDA approved a new indication for a medical device solely based on RWE, with no new clinical trials required. RWE allows for a faster and less expensive alternative to randomized clinical trials. Seeing the FDA increase its use of RWE is vital to its future progress since these regulations set the standard and pave the path where healthcare is and will go.
Healthcare Will Never Be the Same
Real-world evidence and real-world data are fundamentally changing the future of healthcare. Whether it’s solving health inequities, addressing public health concerns like COVID-19, or digitizing individuals and their health records, RWE is important in filling the gaps between research and everyday practice.
Want to learn more about how a degree in real-world evidence can boost your career in healthcare? Check out Northeastern University’s Master of Science in Real-World Evidence program to learn more.
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