Open Payments and the US Clinical Landscape.

Abstract

The Open Payments database represents a new, substantial source of information on the US clinical trial investigator landscape. This paper draws upon the Open Payments database. This database, mandated by the US Sunshine Act, does help provide a vital missing element in understanding the commercial clinical trial landscape in the United States: comprehensive, detailed, clinical investigator and site information by specific clinical trial. Pharmaceutical companies are required to report all payment detail to US-based physicians, including their participation in US clinical trials. The data are available going back to the second half of 2013 and are updated each year. Data compliance is very high. Open Payments data demonstrate, consistent with ClinicalTrials.gov results, a constancy in the level of commercially sponsored clinical trial activity. The number of active clinical investigators for example has remained unchanged each year since 2013. The percentage of one-time investigators is substantially lower than has often been quoted. A strikingly large percentage of investigators in the United States though participate in a very limited number of clinical trials. A large majority of clinical investigators conduct clinical trials in their private practice. Following the US experience, other countries are instituting physician payment databases similar to Open Payments Open Payments provides critical management and operation data, including detailed investigator and site experience data. In addition, it is possible to estimate how investigators performed on each clinical trial.