Our Commitment to Responsible Clinical Trial Data Sharing
We are committed to developing new medicines for patients impacted by difficult-to-treat diseases as safely and quickly as possible. We believe the best way to fulfill this commitment is through clinical studies that evaluate whether our investigational products are safe and effective, which can lead to the medicine being approved and made available to the broadest number of patients possible. Once a product is approved, we continue to evaluate our marketed products by monitoring real world data and engaging in post-marketing clinical trials.
Our clinical trials follow high medical and ethical standards, in accordance with the principles laid down in the Declaration of Helsinki, and are consistent with Good Clinical Practice and applicable local laws and regulations.
By making clinical trial information available, we are:
- Informing patients, investigators and healthcare professionals about the clinical research we sponsor.
- Promoting the distribution of knowledge and minimizing the risk of duplication of research efforts.
- Supporting the publication of full manuscripts in peer-reviewed journals.
- Contributing towards transparency and building mutual trust.
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Information available for researchers
Within six months after the occurrence of an approval of a new product or a new indication for an approved product in both the European Union and the United States after January 1, 2014, Merck KGaA, Darmstadt, Germany, will share study protocols, anonymized patient level, and study level data and redacted clinical study reports from clinical trials in patients with qualified scientific and medical researchers, upon researcher's request, as necessary for conducting legitimate research. If approval of a product is not sought, Merck KGaA, Darmstadt, Germany shall make publicly available such data within eighteen months after the trial completion date. Data will not be shared for products and indications approved prior to January 1, 2014. Clinical Trials in scope of our Responsible Data Sharing Commitment are listed on our clinical trials website. In addition, data will not be shared with our competitors. Learn more about requesting information with the Summary of our Responsible Data Sharing Policy for Researchers.
If you are an appropriately qualified researcher, please see below for more information on how to request data from Merck KGaA, Darmstadt, Germany.
Please note the following: The Data Sharing Agreement found here is a template. We suggest that you review the terms and conditions of our standard Data Sharing Agreement with the appropriate legal and/or contract personnel at your institution before submitting your Research Proposal. The terms of the Data Sharing Agreement are not negotiable. All information must be submitted in English.