Pharmaceutical companies are providing more required information about clinical trials on a federal Web site but are withholding the names of drugs being tested and the main outcomes being measured in some cases, according to a study published Thursday in the New England Journal of Medicine, the AP/Boston Globe reports (Marchione, AP/Boston Globe, 12/28/05). The Web site -- Clinicaltrials.gov -- was created in 2002. It is a public registry of clinical trials of drugs and devices for treating serious illnesses and includes trials on both experimental treatments and treatments already approved for other uses. Editors of the world's leading medical journals in 2004 said they would no longer publish the results of studies not listed on the Web site or on a similar public space. Researchers had until Sept. 13, 2005, to register trials in order to have their work published in major journals, and from May to October 2005 the number of registered trials increased 73% to 22,714 (Sataline, Wall Street Journal, 12/29/05). The study in NEJM -- headed by Deborah Zarin of NIH's National Library of Medicine, which runs the registry -- primarily examined whether listings revealed the name of the drug and the main outcomes being measured (AP/Boston Globe, 12/28/05). The study found that the "vast majority" of companies provided the information, but four -- Merck, Pfizer, GlaxoSmithKline and Eli Lilly -- have withheld the names of some drugs. Smaller companies and noncommercial researchers were generally found to provide more complete information. The four major companies in some trials used terms like "investigational drug" in place of the drug name. Eli Lilly did not list drug names in 3 of 96 trials (Wall Street Journal, 12/29/05). Pfizer did not give drug names in 14 of 224 new listings; GSK did not give the drug name in one of 128 listings; and Merck, which previously had the worst compliance, listed drug names 99% of the time. Merck listed measured outcomes of trials 20% of the time. Novartis listed measured outcomes in 3% of 239 registered trials (AP/Boston Globe, 12/28/05).

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Detlef Niese, vice president of clinical development at Novartis, said patients in trials were given complete details, but the company had reservations about providing public information that competitors might "want to copy." Merck in a statement said it did not want to provide information on early-stage trials because they are "highly proprietary." Stephen Lederer, a Pfizer spokesperson, said, "We're not ready to give to all our rivals what we're doing." A GSK spokesperson said the company was "looking into any omissions." A Lilly spokesperson said, "We've met all the reporting requirements for the registry." Jeffrey Drazen, editor in chief of NEJM, said the federal registry had a "loophole" because it does not require that drug names be disclosed, adding that companies "are meeting the letter but not the spirit of the law." Drazen also said the companies' stated concerns about revealing information to competitors was "a smoke screen." In an accompanying editorial to the study, Drazen wrote that it makes "moral sense" to provide full trial information because "[w]hen patients put themselves at risk to participate in clinical trials, they do so with tacit understanding that their risk is part of the public record, not merely the secret record of the sponsor" (Wall Street Journal, 12/29/05).

The study is available online.