Clinical Trial Information

Merck KGaA, its division for innovative pharmaceutical prescription drugs, Merck Serono and its worldwide affiliates are dedicated to developing innovative medicines that will treat unmet medical needs.  We carry out a series of clinical trials¹ that are approved by regulatory 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. In addition, we continue to evaluate our medicines and medical devices in clinical trials after we have received regulatory approval to market the products.
Our clinical trials are conducted to the highest medical and ethical standards, in accordance with the ethical principles laid down in the Declaration of Helsinki, and that are consistent with Good Clinical Practice and applicable regulations.
Merck KGaA is committed to providing information and transparency about the clinical trials it conducts to the healthcare community and general public, in compliance with applicable regulatory and legal requirements.
For this reason, we support and implement the Joint Position of the worldwide pharmaceutical manufacturers associations.  Our initiative applies to all trials ongoing as of July 1, 2005².
By making such clinical trial information available, Merck KGaA intends to contribute to the following goals:
  1. Enable eligible patients to easily identify and participate in appropriate clinical trials for which they may qualify
  2. Facilitate the compilation of evidence needed for systematic reviews
  3. Accelerate the development, availability and appropriate use of novel medical products
  4. Publish the results of its clinical studies in peer-reviewed biomedical journals
  5. Promote a better understanding of product efficacy, safety, and appropriate use and the practice of evidence-based medicine
  6. Become full participants and partners in the scientific community
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¹ For definitions of Clinical Trials and Phases of trials go to www.clinicaltrials.gov/ct2/info/glossary
² This initiative extends to trials design and results of hypothesis testing trials   initiated on, or after October 15, 2002 with products marketed in the State of Maine, USA
 

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