More Access to Drug Trial Data

The global pharmaceutical industry unveiled plans Thursday to publish more data about trials of medicines in a bid to reassure patients after recent alarms over drug safety.

Trade groups in the United States, Europe and Japan, in collaboration with major drug makers, agreed on an industry-wide code to publish detailed information about all clinical trials, other than exploratory Phase I studies, on the Internet.

The code will be voluntary, but companies are expected to be eager to take part, hoping to head off potentially more onerous legislation in the wake of scandals over pain drug Vioxx and the use of antidepressants by adolescents.

“By publishing not just the results of the trials that have taken place -- whether positive or negative -- but also those that are just starting, the industry has made a major step towards achieving greater transparency,” said Richard Barker, director general of the Assn. of the British Pharmaceutical Industry.

The scheme has the backing of major pharmaceutical companies such as GlaxoSmithKline, Pfizer Inc., AstraZeneca, Merck & Co., Novartis and Sanofi-Aventis, the industry association said.

Under the plan, companies must register trials within 21 days of their start and give each one a unique identifier to ensure easy tracking through multiple databases.

Results should be published within one year of a medicine’s approval or, for trials on drugs that have already been approved, within one year of the trial being completed.

The scheme applies to new trials initiated after July 1, while trials already underway should be included from Sept. 13.

The move does not represent full disclosure, however.

Early stage Phase I studies on healthy volunteers -- often the first sign a company has a good hunch about a new drug approach -- are exempt, and there is no obligation to reveal results of studies before a drug is approved.

“There are issues around commercial sensitivities at the very early stage,” said Richard Tiner, the association’s medical director.

Companies will also not give details on precise clinical trial design, although this might be included in a secure, nonpublic, third-party database for later disclosure.

Controversy about drug companies concealing research, either to prevent rivals from learning too much or because negative results would hit product sales, has been simmering for years.

New York Atty. Gen. Eliot Spitzer brought the issue to a head in June by accusing GlaxoSmithKline of fraudulently suppressing important information about the use of its antidepressant Paxil, or Seroxat, in children. Glaxo settled the case for $2.5 million and agreed to publish results of its drug trials in a registry, setting a precedent for greater disclosure.

Concerns about drug safety have also come to the fore in recent months, with the worldwide withdrawal of Merck’s Vioxx pill in September after it was linked to heart attacks.

And a senior official at the U.S. Food and Drug Administration raised concerns about AstraZeneca’s cholesterol-lowering medicine Crestor in November.