Washington Editor

WASHINGTON - With a bill kicking around the halls of Congress related to clinical trial transparency, some are scratching their heads over a need for such legislation.

"The bill would mandate public disclosure of not only active clinical trials," said Dan McDonald, the vice president of Thomson CenterWatch in Boston, "but also clinical trial result information, which is in itself a very noble cause."

He's not sure the proposed law is essential. McDonald agreed that companies should make data available for consumers, but many already do just that through various registries, and his chief concern lies in the bill's requirement of posting on a central internet registry.

Such an effort already has created the www.clinicaltrials.gov website, though that has had light usage at best. The national registry, which went live in 2000 after being established through a $215 million appropriation, has yet to receive full compliance. McDonald said not quite half the trials that should be on the www.clinicaltrials.gov website are posted.

"There have been no FDA crackdowns on pharmaceutical companies that we know of, to get them to post this information," he told BioWorld Today. "So our point is that it really hasn't worked, not the way it was intended."

Instead, companies have posted clinical trial data on commercial registries, and have done so for about a decade. With a system already in place, McDonald said there isn't necessarily a need for legislation such as the Fair Access to Clinical Trials (FACT) Act of 2005, which Sens. Christopher Dodd (D-Conn.) and Charles Grassley (R-Iowa) introduced in February. Its authors have proposed that the law create a registry on information for all clinical trials conducted to test the safety or effectiveness of any drug, biological product or device, including approved products, intended to treat serious or life-threatening diseases and conditions.

McDonald added that pressure for a government-mandated clinical trials registry also is coming from the International Committee of Medical Journal Editors.

But the FACT Act is of concern to companies that fear submitting proprietary information to the registry.

"It would disclose detailed information about the design of studies, the indication targeted and a little bit about the molecules themselves to competitors," McDonald said. "Obviously, that's a big concern."

Other worries for companies relate to gathering the volumes of data to comply with requirements for such a registry, as well as determining which results, positive or negative, are worth reporting.

Among clinical trial posting services on the market are registries managed by CenterWatch. McDonald, who conceded that his position might seem self-serving, said eight of the 10 largest pharmaceutical companies use CenterWatch. He pointed out that with such an infrastructure in place, the legislation would be surplus.

Some of those drug companies also post data on their own websites, through guidelines suggested by the Pharmaceutical Research and Manufacturers of America and other international pharmaceutical associations. On CenterWatch, consumers can navigate through its registries to seek information on trials, products and research centers, an open-resource public service that does not require registration or personal information.

Given those existing resources, McDonald recommended that all interested stakeholders, including Congressional members, health care companies, patient advocacy groups and commercial registry businesses, work collectively together to create a better disclosure and transparency solution that doesn't duplicate an existing mandate.

"You could appropriate millions of more dollars to create another public registry that might take five to seven years to be populated and might never be complete," McDonald said. "Or you could get behind not necessarily CenterWatch itself, but maybe a consortium of current registries and get the commercial/industry side of this involved in the discussion. That really isn't happening now."

The FACT Act, also labeled S.470, has been referred to the Senate's Committee on Health, Education, Labor, and Pensions. In addition to Dodd and Grassley, other co-sponsors include Sens. Ron Wyden (D-Ore.), Tim Johnson (D-S.D.) and Lincoln Chafee (R-R.I.).