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Open Payments and the US Clinical Landscape.

Harold E Glass1

  • 1Mayes College of Healthcare Business and Policy, University of the Sciences in Philadelphia, 600 S 43rd Street, Philadelphia, PA, 19104, USA. h.glass@usciences.edu.

Therapeutic Innovation & Regulatory Science
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Summary
This summary is machine-generated.

The Open Payments database offers comprehensive clinical investigator data, revealing stable trial activity and a high participation rate among US physicians. This valuable resource aids in understanding clinical trial operations.

Keywords:
Sunshine ActUS clinical trial conductUS investigator experienceopen payments database

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Area of Science:

  • Clinical research operations
  • Pharmaceutical industry
  • Health economics

Background:

  • The Open Payments database provides a new, extensive dataset on US clinical trial investigators.
  • Mandated by the US Sunshine Act, it offers detailed investigator and site information for specific clinical trials.

Purpose of the Study:

  • To analyze the US clinical trial investigator landscape using the Open Payments database.
  • To provide insights into physician participation and trial activity within the commercial clinical trial sector.

Main Methods:

  • Utilized the Open Payments database, which collects payment details reported by pharmaceutical companies to US physicians involved in clinical trials.
  • Data spans from the second half of 2013, with annual updates and high compliance rates.

Main Results:

  • Open Payments data confirm consistent levels of commercially sponsored clinical trial activity since 2013.
  • The percentage of one-time investigators is lower than previously estimated, with many investigators participating in a limited number of trials.
  • A majority of clinical investigators conduct trials in private practice settings.

Conclusions:

  • Open Payments data offer critical operational insights into clinical trials, including investigator experience.
  • The database enables performance estimation for investigators on specific clinical trials.
  • Similar physician payment databases are being adopted internationally, following the US model.