More harm than good? Fed database stirs controversy

Critics: Database opens CTs to second-guessing

The clinical research industry is bracing itself for the next phase of the federal government's research database and the addition of CT results.

The Department of Health and Human Services (HHS) is expected to release proposed rules about how sponsors and research sites should comply with the requirement, which was part of the Title VIII of the Food and Drug Administration Amendments Act of 2007 (FDAAA, Public Law 110-85, section 801), to provide greater transparency in clinical research.

Originally, the Food and Drug Modernization Act (FDAMA) passed in November, 1997, mandating that the National Institutes of Health establish and operate a public resource for information about clinical trials. NIH established a data bank located on-line at, in 2000. The data bank reached its 1,000th CT listing in 2003 and has continued to grow to more than 60,000 trials listed.

The FDAAA requires CT sites and sponsors to submit data after a trial is completed to provide summary results statistics for drugs, medical devices, and biological products that have been approved by the FDA.

The results database will build on the existing listings, allowing sponsors and principal investigators to submit basic results summary data for public view.

Soon there should be federal rules for how the CT industry can expand its listings in the data bank to include results. And this is what worries some in the industry.

"Both as a lawyer and a consultant in the world of clinical research, I've been asked by many clients how they can comply with these requirements," says Mark Barnes, JD, managing director of Huron Consulting Group, which is headquartered in Chicago, IL, and also located in Boston, MA, and New York, NY, as well as other cities.

"People wonder what the ultimate ramifications and consequences would be for these requirements," Barnes says.

So far there is no results database, but some preliminary information about it is expected in 2009 or 2010.

The 2007 legislation requires the registry of clinical trials to include both results and the occurrence of adverse events, Barnes says.

"This is something that has never been done by the government before, although there are pharmaceutical companies that have begun to put results of trials they sponsor on their own Web sites," he says.

Transparency goal clouded

Congress' theory for this legislation is that it will create a lot of transparency in research, Barnes notes.

"But the problem is that there are a lot of badly-designed trials out there, and a reader who looks at the results data will not know which is the well-designed trial and will be published in a peer-reviewed journal and which is not," Barnes explains. "The bottom line is that less is often more."

The legislation requires all results to be listed regardless of whether the results ever are published, and this creates a number of problems, Barnes adds.

"Whenever there's a bad outcome in an approved medication or medical device the media are going to go to the results database to look to see if there were ever any bad results from clinical trials, and, of course, there were bad results," Barnes says. "There always are bad results."

So the results database will be used to second-guess CR decisions, and it will be used against the industry by the media and plaintiff's malpractice lawyers, he adds.

"The ultimate result might be an even greater timidity for drug companies and device companies and biotech companies to test innovative products and take them to market, Barnes says.

"This is widely thought to be a potential consequence of this legislation," Barnes says.

Even worse, there might be a chilling affect on academic research as well, he says.

"Trials might be designed in the first place to minimize negative results and to maximize positive results," Barnes explains. "Think about it: if you are a drug company are you going to want to do risky trials?"

This is why the mandate for more information could lead to even less information, he says.

"There are multiple secondary and tertiary consequences to mandating secondary actors using NIH funds or institutional resources to listing CT results," Barnes adds.

"What has happened here is Congress in a stampede toward disclosure as a panacea for all these ills has taken a meat ax when a scalpel will do," he says. "If the FDA is being denied essential information it needs in deciding approval of these drugs, then we can get to that information without mandating disclosure on public Web sites."

In fact, the FDA already has the right to look at unpublished CT data, he notes.

"What has deterred the FDA is the lack of staff to investigate and run down all the information they need to find," Barnes says.

"We're all waiting for the proposed rules to come out, and that's when the fight will begin," Barnes says. "They won't be proposed until the new administration comes in, and there are lots of variables between now and then."