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Drug Companies Offer More Details on Clinical Trials

But greater effort is needed to supply a more complete picture, study finds

WEDNESDAY, Dec. 28, 2005 (HealthDay News) -- Thanks to new requirements, more clinical trials -- including those involving drugs under development -- are being registered in a national database, a new study has found.

The summer of 2005 saw a surge in the number of trials registered in the publicly available database and, in general, the information provided was more complete in October than it was in May.

However, there is still room for improvement when it comes to details of trials involving new drugs, said the authors of the study appearing in the Dec. 29 issue of the New England Journal of Medicine.

"The good news is that there's been a lot of compliance with requirements in terms of trial registration," said Dr. Jeffrey Drazen, editor-in-chief of the journal and co-author of an accompanying editorial. "It's good progress and we're encouraged by that, but there's a long way to go."

"It's very encouraging to see the response," added Dr. Mark Fendrick, a professor of internal medicine at the University of Michigan School of Medicine.

Recent safety problems with high-profile drugs such as the antidepressant Paxil (made by GlaxoSmithKline) and the painkiller Vioxx (made by Merck) have highlighted the importance of making public the information coming out of research trials involving medications, the researchers said.

Many experts are especially concerned about the moral and safety implications of apparently withholding information from people who willingly participate in these trials. On the other hand, companies conducting the trials balk at the idea of making proprietary information available before a drug is fully developed.

In the United States, the U.S. Food and Drug Administration Modernization Act of 1997 requires that all private and public trials that involve treatment of "serious or life-threatening conditions" under the investigational new drug (IND) protocol be registered. ClinicalTrials.gov was established in 2000 as a result of this law. But the database allows the registration of any clinical trial, not just those mandated by the modernization act.

On Sept. 13, 2005, a policy set forth by the International Committee of Medical Journal Editors (ICMJE) was implemented. The policy raised the bar for researchers even further by requiring the registration of clinical trials if they are to be considered for publication.

The authors of the new study assessed information in ClinicalTrials.gov from May 20 through Oct. 11, 2005, a time frame purposely straddling the implementation of the ICMJE policy.

During that period, the number of registrations increased by 73 percent -- from 13,153 to 22,714. Clearly, the ICMJE policy had an effect.

"That spike in the summer didn't happen for no reason at all. I think people are getting the message," Drazen said.

The percentage of trials with nonspecific entries in the "intervention name" field -- such as drug, surgical procedure or device -- decreased from 10 percent to 2 percent. These trials were attributable to four drug companies. All other records contained specific entries in this field, the study found.

Some large pharmaceutical companies, such as Merck, GlaxoSmithKline and Pfizer, "provided meaningful entries in the intervention name field in an astonishingly low number of registrations," the Drazen editorial stated.

Merck eventually "cleaned up its act" by updating most of its entries, Drazen said. The other two companies have not shown the same improvements, he said.

Of the 2,670 studies registered by industry during the time interval, 76 percent provided information in the "primary outcome measure" field, although the entries varied in terms of how specific they were. The field was blank in the remaining 24 percent of records. Before May 20, 2005, according to the authors, this field was usually left blank. Now the information is more likely to be left out for phase 4 -- or late-stage -- trials.

By October 2005, Drazen's editorial stated, Novartis had completed this field only 3 percent of the time and Merck only 20 percent of the time, even though many of their competitors were in full compliance.

"We need people to fill out all the fields in a meaningful fashion," Drazen said. "Everyone ought to know what's going on."

Asked to comment on the study findings, Merck offered this statement: "Merck is pleased that the article published in this week's issue of the NEJM acknowledges the progress that we have made in the registration of clinical trials on ClinicalTrials.gov."

"As we've said many times, Merck is committed to registering all Phase II, III, and post-marketing controlled clinical trials and we have done so, as evidenced by the NEJM article In fact, Merck's commitment to voluntarily registering these trials goes beyond the industry commitment to register all 'confirmatory' trials. This is, as you know, in addition to those required by the current U.S. law mandating registration of clinical trials of products designed to treat life-threatening or otherwise serious illnesses."

One question not addressed by the study is how useful even complete information will be.

"What remains to be seen is whether the information entered into these registries actually become useful down to the level of the individual," Fendrick said. "Hopefully, the infrastructure is behind this to make it user-friendly."

More information

To find out more on how clinical trials are conducted, visit the U.S. National Institutes of Health.

SOURCES: Jeffrey M. Drazen, M.D., editor-in-chief, New England Journal of Medicine, Boston; Mark Fendrick, M.D., professor, internal medicine, University of Michigan School of Medicine, Ann Arbor; Dec. 29, 2005, New England Journal of Medicine
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