Tangential headwinds when integrating industry-funded clinical trials into a US health care delivery system

Although there are regulatory obligations put forth by the US Food and Drug Administration (FDA) that directly govern clinical trials and other investigational therapies, such activity does not occur in a vacuum. There are other regulations and administrative policies that are tangential to the operations of clinical trials in a health system that can have a direct or indirect effect. Regulations such as HHS's Common Rule and Right To Try have been rapidly evolving over the past couple of years. Also rapidly evolving in this timeframe are the federal government's administrative branch policies involving incentives and disincentives for electronic health records as well as how quality is measured electronically. All of this is occurring as the entire health care delivery sector is trying to reinvent itself with both existing and new unexpected players. Thus, while those interested in conducting industry-funded clinical trials in their health system generally know to keep up with FDA, they must also be diligent to see how the greater system is forced to evolve to assure that they remain successful form a regulatory and operational standpoint.