Is the Sunshine Act Pushing Research Out of US?
An analysis by Life Science Compliance Update of the U.S. government's Open Payments database shows that industry spending on U.S-based clinical research has dropped 32% in the first year-over-year comparison since Open Payments data started to be collected.
An analysis by Life Science Compliance Update of the U.S. government's Open Payments database shows that industry spending on U.S-based clinical research has dropped 32% in the first year-over-year comparison since Open Payments data started to be collected.
The analysis shows that drug and device manufacturers reported about $1.5 billion in research payments from August through December 2013, the first reporting period under the new law. This fell to around $1 billion during the same five-month time frame in 2014. As a result, physicians, academic institutions and third-party research organizations received nearly $500 million less in research funding during the comparable period in 2014.
With the help of Open Payments Analytics, Life Science Compliance Update authors found that the decline in research was not isolated by recipient type, geographic location, or specialty. The authors suggest that it’s early to identify what is driving this trend, for example, moving research dollars to global trials; increasing numbers of physicians employed by hospitals thus having less autonomy or time to conduct research, or the added scrutiny of Open Payments reporting as a disincentive to U.S.-based research.
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
