Sponsors need to assure GCP compliance to reduce legal liability.(Sponsor/monitors)

PHILADELPHIA -- Given that clinical trials are under siege in the courts and in the public eye, trial sponsors would be wise to assure that GCPs and the importance of data integrity are fully embraced by IRBs, investigators and clinical staff.

This was the message of several speakers at CBI's meeting in Philadelphia Dec. 4-5. They suggested that a number of areas that are not traditionally the responsibility of the sponsor now are falling under their purview.

The most damaging issue is misconduct or outright fraud in a clinical trial, and how regulators will view a sponsor's complicity in it. Overall, a wider net is being cast and sponsors are liable to be caught in it. "It's a slippery slope from noncompliance to fraud," said Jeffrey Trunzo, VP of Chesapeake Research Review, a Columbia, MD-based IRB. "And, the regulators have the tools to identify and address these issues."

Where fraud is found, Trunzo said, "this inherently means the data is bad and patient safety has been compromised." And where there is bad data, "the trust is broken that the patient is participating in something that's contributing to the overall good."

Here, Trunzo sounded an important theme: "Fraud is difficult to detect using normal channels. Typically, someone inside--a whistleblower--draws attention to it. The safeguards we have in place are designed to find misconduct, not fraud.

"You need to have a mechanism where the bells go off when fraud is suspected, and then have the resources to investigate it," he said.

That mechanism should be embodied in a compliance program, instituted by the sponsor. The program should operate independently and should have not only QA responsibilities, but also budgetary accountability.