Clinical Trial Information
Merck KGaA and its worldwide affiliates are dedicated to developing innovative medicines that will treat unmet medical needs. First we conduct lengthy preclinical testing that confirms that a substance will actually have the anticipated effect along with an appropriate safety margin in animals. We also do extensive formulation work to produce a product that can be delivered to humans. Only then do we begin clinical testing.
We carry out a series of clinical trials, approved by regulatory authorities and ethics committees, to evaluate each investigational drug to determine how it acts and whether it is safe and effective in the target human population. Phase I trials usually involve healthy volunteers and sometimes patients with the illness. These trials study the safety of the drug and its interaction with the body, including its concentration in the blood. In Phase II trials, we use the doses suggested by the Phase I trials in small numbers of patients with the illness and further seek to determine the proper dose for providing effective treatment. Only when Phase II results are encouraging, we conduct Phase III trials in large numbers of patients under controlled conditions, seeking to provide confirmatory evidence of the efficacy and safety of the drug. All data are provided to the regulatory authorities for their consideration in approving the drug. After approval for marketing, further Phase IV trials might be conducted to learn more about the drug. We conduct all clinical trials worldwide to the highest medical and ethical standards and according to Good Clinical Practice and with the oversight of institutional ethics committees.
Merck KGaA is also committed to providing information and transparency about the clinical trials it conducts. For this reason, we are supporting and implementing the Joint Position of the worldwide pharmaceutical manufacturers associations. Our initiative affects all trials ongoing as of July 1, 2005, and subsequent trials and is formalized under our Global Policy on Clinical Trial Registration and Results Disclosure.
Clinical Trial Registration
First, we will register key protocol information for all of our confirmatory trials at their initiation in a publicly-accessible, free clinical trial registry, www.clinicaltrials.gov.
First, we will register key protocol information for all of our confirmatory trials at their initiation in a publicly-accessible, free clinical trial registry, www.clinicaltrials.gov.
Clinical Trial Results Disclosure
Second, we will provide a summary of trial results in a publicly-accessible, free clinical results database, www.clinicalstudyresults.org. The results will be provided for confirmatory trials of our marketed products completed after January 2005 and be available within one year of product launch or subsequent trial completion.
Second, we will provide a summary of trial results in a publicly-accessible, free clinical results database, www.clinicalstudyresults.org. The results will be provided for confirmatory trials of our marketed products completed after January 2005 and be available within one year of product launch or subsequent trial completion.
We have also endeavored to publish the results of all clinical trials in the 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 those cases. Once published, the results summary will include the publication citation.
