Merck KGaA Provides Information, Transparency on Clinical Trials

Published 07-28-05

Submitted by Merck KGaA, Darmstadt, Germany

DARMSTADT, Germany--(BUSINESS WIRE)--July 28, 2005--Merck KGaA announced today that it will provide up-to-date information on its important ongoing clinical studies. It will also disclose information on completed clinical studies. Making this information available is intended primarily to help patients, their caregivers and physicians find clinical trials that may be appropriate for them and for which they may qualify and for the public to have access to key clinical study results.

For these reasons, Merck is supporting and implementing the Joint Position of the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA). Merck's initiative affects all trials ongoing as of July 1, 2005, and subsequent trials and is formalized under Merck's Global Policy on Clinical Trials Registration and Results Disclosure.
"Merck is committed to providing information and transparency about the clinical trials it conducts," said Thomas Lander, Executive Vice President Global Clinical R&D. "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".

Clinical Trial Registration

First, Merck will register key protocol information for all of its confirmatory trials at their initiation in the publicly accessible, free clinical trial registry ClinicalTrials.gov.

Clinical Trial Results Disclosure

Second, Merck will provide a brief summary of the results of trials in the publicly accessible, free clinical results 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.

Merck will also endeavor to publish results of all clinical trials in medical literature and will continue to do so as stated in our Publication Policy. Posting of summary results in ClinicalStudyResults.org will follow publication in these cases.

Further Information:

Clinical trials: http://www.merck-trials.de/

Joint position statement: http://www.efpia.org/4_pos/sci_regu/Clinicaltrials2005.pdf

Clinical trial registry: http://www.clinicaltrials.gov/ct/info/about

Clinical results database: http://www.clinicalstudyresults.org/

All Merck Press Releases are distributed by e-mail at the same time they become available on the Merck Website. Please go to http://www.subscribe.merck.de to register online, change your selection or discontinue this service.

Merck is a global pharmaceutical and chemical company with sales of EUR 5.9 billion in 2004, a history that began in 1668, and a future shaped by 28,600 employees in 54 countries. Its success is characterized by innovations from entrepreneurial employees. Merck's operating activities come under the umbrella of Merck KGaA, in which the Merck family holds a 73% interest and free shareholders own the remaining 27%. The former U.S. subsidiary, Merck & Co., has been completely independent of the Merck Group since 1917.

Merck KGaA Provides Information, Transparency on Clinical Trials

Merck KGaA Provides Information, Transparency on Clinical Trials

Merck KGaA, Darmstadt, Germany

Merck KGaA, Darmstadt, Germany

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