Pressure on Investigator-Pharma Relationships Brings New Wave of Scrutiny, According to Cutting Edge Information

RESEARCH TRIANGLE PARK, NC--(Marketwire - May 28, 2009) - As regulation clamps down on the commercial relationships between the industry and physicians, proponents of the scrutiny, such as Senator Charles Grassley (R-IA), are starting to look at the relationships between investigators and the industry. According to a new study by Cutting Edge Information, "Managing Clinical Investigator Compensation," companies should reassess compensation structures and processes to prepare for imminent scrutiny on clinical investigators (http://www.ClinicalInvestigatorCompensation.com).

The latest wave of public scrutiny over physician and academia-pharmaceutical industry relationships could have significant implications for institutions that rely on NIH funding. Investigators who conduct federally funded studies and also receive outside compensation, especially from the company that manufactures the drug being tested, can jeopardize future NIH funding for their academic institutions.

Pharmaceutical companies already face a public relations scenario in which payments to physicians for promotional or educational activities come under fire. However, thanks to Good Clinical Practices (GCP) guidelines, payments to clinical investigators have not faced similar scrutiny. Yet that scenario may be inevitable, according to Cutting Edge Information's new research.

Clinical cost structures and investigator compensation methods are varied and leave room for vague compensation ranges. In addition, the relationships between investigators and companies come though many different avenues, including investigator-initiated trials, CROs, and academic institutions. In today's environment of ever-tightening regulation and oversight, companies should proactively employ processes to seek to protect themselves against future regulatory scrutiny.

"Through our research, we found companies thinking of applying FMV protocol to the clinical side," said Jordan Stone, Cutting Edge Information research analyst and lead author of the report. "Due to the scientific nature of the relationship, other companies will not take that approach. But determining a market-price for investigators based on a set criteria both holds down costs and eliminates the risk of a future investigation."

"Managing Clinical Investigator Compensation" examines clinical investigator compensation data, collected from drug and device makers, as well as directly from investigators. A complimentary brochure is available for download at http://www.cuttingedgeinfo.com/clinicalinvestigatorcompensation/PH126_Download.asp#body.

Contact Information: CONTACT INFORMATION: Jordan Stone 919-433-0376