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ISPE’s Position on Real World Evidence (RWE)

UBC’s experts break down the latest from the International Society for Pharmacoepidemiology.
Read more about the February 2020 position on RWE from ISPE.

In February 2020, the International Society for Pharmacoepidemiology (ISPE) released a position statement on Real World Evidence (RWE). Here is a summary (You can read the full statement here):

  • ISPE has contributed to the development of RWE methods for more than 30 years
  • ISPE applies robust epidemiological, causal inference, and data science methods using a wide variety of Real World Data (RWD) sources (e.g., electronic health records and registries)
  • Randomized controlled trials (RCTs) will continue to serve as the major evidentiary standard for regulatory approvals, however, RWE derived from well-designed studies, with the application of rigorous epidemiologic methods, combined with judicious interpretation, can offer robust evidence regarding safety and effectiveness.
  • ISPE is encouraged to see regulatory agencies now considering RWE to support new indications, labeling changes, and for the approval of new products.
  • ISPE members can provide guidance and drive innovative solutions on key RWE issues, including identifying the optimal study design and which data sources are “fit for purpose,” amongst others.

In summary, ISPE leads and drives exciting new developments in RWE via the breadth of experience and expertise in epidemiologic research of its members, and seeks to collaborate with key stakeholders to further the use and science of RWE.

Learn more about UBC’s expertise and consulting capabilities in accelerating evidence generation.

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Bekki Bracken Brown serves as the President and CEO of UBC, guiding the company’s mission and values, including the improvement of access for patients to receive better outcomes. She oversees all aspects of UBC, such as operations, business growth strategy, sales and marketing, and acquisition support.

With over 20 years of industry experience, Ms. Brown brings knowledge from a successful career in senior management from her tenure at Quintiles, INC Research, and, most recently, with Syneos Health. She’s been a member of the North Carolina BIO Board of Directors since 2019. She is also a member of the Healthcare Businesswomen’s Association — Southeast Chapter and CHIEF, an organization that supports women executive leaders. Ms. Brown earned her bachelor’s degree at Duke University.