New Bill Would Require Disclosure of All Clinical Trial Results
Written By: Rheingold, Giuffra, Ruffo & Plotkin LLP
A new bill introduce by Congressman Tom Green (R) from upstate New York would require the results from all clinical trials be disclosed regardless of the outcome of the trial. This bill comes after more research has shown that results from government funded clinical trials often go unreported despite the disclosure requirements already in place. The new bill would amend the Public Health Service Act, adding a stronger enforcement mechanism. The bill says once it has been verified that the results of a clinical trial haven't been reported, the grantee:
"shall not be eligible to recieve any remaining funding for the grant or funding for a future Federal grant until such time as the grantee comes into complicance with all applicable reporting requirements...and shall be liable to the United States for repayment of any amount provided under the grant for clinical trial for which the grantee failed to comply with such reporting requirements."
One study reported in the British Medical Journal reported less than 30% of trials registered with clinicaltrials.gov are in compliance with the requirements already in place.
An article recently published in Pediatrics reported that only 29% of 2,385 pediatric clinical trials registered with clinicaltrials.gov ever reported their results and on average the results weren't published for two years after the study had completed. Additionally, only 53% of the trials funded by the National Institute of Health were ever reported. Further, results from terminated or suspended clinical trial were rarely ever reported
Rheingold, Giuffra, Ruffo & Plotkin LLP is deeply involved in the pharmaceutical and device litigations we handle. This gives us the opportunity to uncover some of the hidden results of clinical trials never reported by the pharmaceutical companies that sponsor them. It is shocking what companies sometimes don't disclose, but through litigation much of this information is eventually made public and the world is a better place as a result.