Real World Evidence
Real World Evidence (RWE) is a potentially transformative new tool in drug and medical device development which could help lead to faster and less expensive FDA regulatory approvals. Neil Belson is among the first attorneys in private practice to focus on RWE.
What is “Real World Evidence?”
RWE is clinical evidence regarding the potential risks and benefits of medical products, obtained in the course of patient health care from sources as physician electronic health records and insurance claims data. Because it is obtained from medical treatment under “real world” conditions, the data used to support RWE studies contrasts with the type of data traditionally used in FDA regulatory submissions which is obtained from carefully monitored randomized clinical trials.
A recent pharmaceutical industry survey by Deloitte found that over 90% of pharmaceutical industry respondents expect RWE to be an important part of their organizations by 2022. Former FDA Commissioner Dr. Scott Gottlieb called expanded use of real world data in regulatory decisions “a key strategic priority for the FDA.”
How Can Real World Evidence Help Me?
RWE can potentially help you develop or commercialize your new drug, biologic or medical device in many ways:
- Reducing the time and cost of product approvals
- Obtaining expanded product labeling
- Complementing clinical trials to obtain FDA approvals
- Reducing costs of post-commercial marketing commitments
- Demonstrating product superiority
- Obtaining approvals by payers
Neil Belson’s Real World Evidence Practice
Mr. Belson is at the cutting edge in identifying ways to use RWE to benefit clients. His experience includes the following:
- Advising companies on using RWE for regulatory purposes.
- Producing a series of podcasts with the Medical Affairs Professional Society on Real World Evidence.
- Preparing a monograph for ISPOR, the international health economics and outcomes research (HEOR) society, on “Hypothesis-Evaluating Treatment Effect” (or “HETE”) studies which are used to generate Real World Evidence.
Mr. Belson’s Publications and Presentations on Real World Evidence and Related Topics
Mr. Belson has written and spoken on use of Real World Evidence for regulatory purposes. His publications include the following:
- “Emergence of Real World Evidence in Precision Medicine.” In S. Mousa, R. Bawa and G. Audette (eds.), The Road from Nanomedicine to Precision Medicine, 36: 1151-1166. Jenny Stanford Publishing PTE Ltd., Singapore, 2019.
- “FDA’s Historical Use of Real World Evidence”. FDLI Update Magazine, August-September 2018.
- “New FDA Guidances on NGS-Based Testing May Bolster Personalized Medicine”. Personalized Medicine Coalition, Education and Advocacy, June 6, 2018.
- “Regulatory Applications of Real World Evidence”. Journal of Precision Medicine: March-April 2018: pp: 54-59.
- “Contemporary Applications of Real-World Evidence in Regulatory Decision-Making: A Case Series Review”. Medical Affairs Professional Society.
- “How Can Real-World Evidence Help Medical Affairs Professionals?”. Medical Affairs Professional Society.
- “Impact of the 21st Century Cures Act”. Medical Affairs Professional Society.
Contact Us Today
At Law Office of Neil A. Belson, LLC, we leverage our deep understanding of Real World Evidence with our legal expertise to help our clients. Contact us to schedule a free initial consultation. Call 240-448-4255 or email us today.