In the US, the pharmaceutical industry sponsors almost all clinical research dealing with investigational medications and devices ultimately submitted for FDA approval and marketing.   What does it mean that a pharmaceutical company "sponsors” research?  In reality, pharmaceutical company sponsorship means that employees and paid consultants for pharmaceutical industry write the research study protocols, select the researchers and research sites where clinical trials are conducted, and ultimately control the language and content of publications in which the research data results are presented.  

Clinical research has transformed from a process that was primarily focused at academic centers to a highly competitive business environment, with private, for-profit research only centers, academic departments, and community based physicians competing to conduct clinical trials.  Serious concerns have arisen as to whether competitive business interests exert inappropriate influence on research sites to act more in their own business interests and less in protecting patients’ interests.  Poorly trained research staff, lack of physician involvement in the daily research operations and patient medical supervision, and researchers conducting trials outside their area of specialty or expertise are areas of concern cited by the FDA. Although the federal government has established regulations regarding the conduct of pharmaceutical sponsors, research sites, institutional review boards, and physicians in performing clinical research, enforcement of regulations remains an issue.

Ultimately, the integrity of research data depends upon the proper conduct of researchers, research sites, and the employees and paid consultants to the pharmaceutical industry.  In its final assessment of the safety and efficacy of investigational medications, the FDA is entirely reliant upon the data generated by the pharmaceutical company sponsored trials process. 

The FDA Office of Good Clinical Practice (OGCP) is the main federal agency for issues related to industry and researcher conduct of human clinical research.  The Links below provide access to more information regarding the clinical trials process, currently registered US clinical trials, and federal regulations guiding the research industry.