The Increasing Use of Real-World Evidence in Clinical Trials
Historically, clinical data for drug approvals are generated through randomized clinical trials. However, with technological innovations and changes within regulatory agencies, the clinical research landscape is evolving to include real-world evidence (RWE) across a broad range of clinical applications.
What is RWE?
Real-world evidence in clinical research is clinical evidence regarding the use and potential benefits and risks of a medical product or device. Real-world evidence is derived from observational data collected in real-world settings. These data, referred to as real-world data, may be collected from a variety of sources.
Real-world data sources may include the following:
Healthcare databases
Electronic health records
Patient and disease registries
Insurance claims and billing activities
Patient-generated data
Mobile health technology
— Mobile phone trackers
— Wearables and biosensors
Patient surveys
Social media
The integration and increasing use of RWE
To date, RWE has usually been used for postmarketing safety surveillance. However, regulators are encouraging clinical research sponsors to use RWE for submissions and, when appropriate, to assess drug effectiveness in earlier phases of development.
In 2016, the United States Congress passed the 21st Century Cures Act to streamline and expedite the drug approval process. This act required the FDA to create a framework and provide guidance for the use of RWE within the regulatory process.
Real-world evidence is being used instead of and in addition to data collected from randomized clinical trials.
Therapeutic areas in 2022 with the highest number of studies using RWE:
The Potential of RWE
Integrating RWE and randomized clinical trials may help improve outcomes, make drug submissions more robust, and expedite the drug approval process.
Real-world evidence has the potential to generate additional medical discoveries, especially in areas where traditional trials may be unethical or not possible. It may also provide more comprehensive clinical evidence for specific patient populations, such as those
who have a rare disease
for whom a randomized clinical trial may be difficult to perform, such as in pediatric or pregnant populations
who have comorbid conditions
outside of the typical clinical trial age range
living in a remote geographic area
In addition, RWE can assess the effects of a drug over a long period.
Benefits and applications of RWE
Using RWE across the clinical research continuum can help provide new and actionable insights. For example, by leveraging electronic health records to identify potential subjects, RWE can improve study enrollment and the identification of viable site locations. Real-world evidence can also provide additional and more broadly-based clinical evidence by utilizing data that is readily available and easy to access.
Such applications would lead to increases in efficiency and cost savings with a promise of improving the drug discovery process, identifying more unmet needs, and optimizing health economics now and in the future.
How can Artcraft Health help?
The Clinical Trials Team at Artcraft Health can help you to optimize available data to support your clinical research objectives. Our experienced team can help you collect and apply RWE through our digital strategies, such as apps, websites, analytics, and customized interactive platforms.
References
Beaulieu-Jones BK, Finlayson SG, Yaun W, et al. Examining the use of real-world evidence in the regulatory process. Clin Pharmacol Ther. 2020;107(4):843.852. www.ncbi.nlm.nih.gov/pmc/articles/PMC7093234/
Newton W. Getting real: who is leading the real-world data charge with clinical trials? Clinical Trials Arena website. Published September 9, 2022. Accessed October 3, 2022. www.clinicaltrialarena.com/analysis/real-world-data-charge/
Real-world data (RWD) and real-world evidence (RWE) are playing an increasing role in health care decisions. U.S. Food & Drug Administration website. Updated September 8, 2022. Accessed October 4, 2022. www.fda.gov/science-research/science-and-research-special-topics/real-world-evidence
Written by Linda Lipp, Medical Writer
Linda Lipp is a senior medical writer at Artcraft Health. She has helped craft content for a variety of clients in the pharmaceutical, clinical trial, medical device, and patient education industries. Linda is passionate about science, education, wellness, nutrition, and the great outdoors. She has been a valued contributor at Artcraft Health since 2013.