Journals to require trial registration

The International Committee of Medical Journal Editors (ICMJE) said that its 11 member journals will require registration in a public trials registry for clinical efficacy studies beginning after July 1, 2005, "as a condition of consideration for publication." Sponsors must register trials by the time enrollment begins. Trials begun before July 1, 2005, must be registered by Sept. 13, 2005, to be considered for publication. Studies designed to assess toxicity and pharmacokinetics will be exempt.

Separately, the Pharmaceutical Research and Manufacturers of America said it will launch its previously announced clinical trials database on Oct. 1 (see BioCentury Extra, Thursday July 1, 2004). The database will contain published articles and unpublished summaries of controlled clinical trials (primarily Phase III and IV) completed since October 2002 for marketed drugs from PhRMA members. The database also will be open to non-PhRMA members that market drugs in the U.S. The database will be available at http://www.clinicalstudyresults.org ...