Germany’s Merck KGaA this morning joined a raft of companies planning to disclose clinical trial information of both ongoing and completed studies. At Merck, the move affects all trials ongoing as of July 1, 2005.
In a climate of building patient and public distrust of the pharmaceutical industry, Merck KGaA is one of a cluster of firms to launch such an initiative. The issue of clinical trial disclosure came to the fore last summer, when New York Attorney General, Eliot Spitzer, filed a lawsuit against GlaxoSmithKline, alleging that the UK drugmaker had suppressed negative results showing its antidepressant Paxil (paroxetine) was linked to an increased risk of suicidal thoughts and acts in children and adolescents [[03/06/04a]]. The Industry responded to this controversy by committing to a worldwide clinical trials register [[07/01/05a]]. Meanwhile, some individual pharmaceutical companies have unilaterally established their own databases, including GSK, Merck & Co, Forest Laboratories, Eli Lilly and Roche.
Said Thomas Lander, Executive Vice President Global Clinical R&D, Merck KGaA: “It is our goal to build mutual trust among all participants in the healthcare enterprise: physicians, patients, healthcare providers, clinical trial investigators, government agencies and pharmaceutical manufacturers.”
First, Merck will register key protocol information for all of its confirmatory trials at their outset in the publicly accessible clinical trial registry ClinicalTrials.gov. Second, Merck will provide a brief summary of the results of trials in database ClinicalStudyResults.org. The results will be provided only for confirmatory trials of marketed products completed after January 2005 and be available within one year of product launch or subsequent trial completion.