Open Payments and the US Clinical Landscape.

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.