humani nil a me alienum puto

random rants about news, the law, healthcare law, economics and anything I find amusing

An Overseer of Medical Trials Comes Under Fire – NYTimes.com

The NYT reports:

“The company, Coast Independent Review Board, of Colorado Springs, was recently snared when undercover federal investigators created a sham medical study to see how closely companies like Coast evaluate the studies they are paid to review. Two of Coast’s competitors refused to approve the study’s design. But Coast approved a trial, involving a make-believe surgical product called Adhesiabloc and researchers who did not exist. *** The hearing follows incidents in recent years in which patients have died during clinical trials or companies have submitted fraudulent data to the Food and Drug Administration to get new medical products approved. During this period, the oversight of clinical trial safety has shifted from academic medical institutions to commercial firms like Coast. ***Over a five-year period, Coast reviewed 356 study proposals and rejected only one[.] *** In a report presented at Thursday’s hearing, officials of the Government Accountability Office, a research arm of Congress, said they had found that the commercial review system was vulnerable to manipulation.***In responding to undercover solicitations from G.A.O. investigators, two other companies — Argus Independent Review Board, of Tucson, and Fox Commercial Institutional Review Board, of Springfield, Ill. — refused to approve the Adhesiabloc plan. In their responses, they called the trial design “awful,” and “a piece of junk,” according to the G.A.O. ***In another part of the G.A.O. operation discussed at the hearing, investigators last year created a fictitious clinical trial oversight company and registered it with the department.

via An Overseer of Medical Trials Comes Under Fire – NYTimes.com.

Advertisements

Filed under: Conflicts of Interest, Drug Policy, Fraud and Abuse, Health Law, Reform, , , ,

Pages

October 2017
M T W T F S S
« Oct    
 1
2345678
9101112131415
16171819202122
23242526272829
3031  

HealthCounsel Tweets

Error: Twitter did not respond. Please wait a few minutes and refresh this page.