Our Commitment to Responsible Clinical Trial Data Sharing

As a leading science and technology company, the sharing of information related to clinical trials sponsored by our Healthcare business is central to our mission.


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.

For more information: click here

Information available for researchers

Following 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. Data will not be shared for products and indications approved prior to January 1, 2014. 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.

Interested 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.

Step 1: Requesting Data

Step 1: Requesting Data

On this website you will find a request form below that you are kindly asked to fill in and submit. Please review the forms carefully for required information before starting. Additional information on how to complete the forms and who is eligible is provided for you to download. After completing and submitting the Research Study Proposal Request Form below, please click on the submit button. You should then receive an e-mail automated receipt confirmation of your request.

Step 2: Research Evaluation

Step 2: Research Evaluation

Merck KGaA, Darmstadt, Germany will evaluate the Research Proposal using a number of criteria, including but not limited to:

  • All documents submitted, complete, comprehensive and in English;
  • Qualifications and experience of Lead Researcher and Research Team, including biostatistical competencies;
  • Scientific merit of the Research Proposal, including any unmet medical need and/or interest of patients/public health and a clear research hypothesis;
  • Evaluation of conflict of interest disclosure;
  • Whether is it feasible to anonymize the data without compromising the privacy of clinical trial participants, which our company is legally obliged to protect;
  • Whether the data is available;
  • Whether a publication/posting plan is in place.

Evaluation of the Research Proposal, as well as the qualifications and experience of the Lead Researcher and Research Team, will be conducted by appropriate and qualified person or board.

Step 3: Accessing Data

Step 3: Accessing Data

If you have received a favorable response you would then be eligible to access data based on these conditions:

  • Signing and returning our standard Data Sharing Agreement before any access to data will be given (the terms of this Agreement are not negotiable);
  • You agree that data cannot be copied, stored and/or extracted from the secure server where you will be provided access to the data, you may, however, extract your analyzed results;
  • You agree to our Data Privacy Statement;
  • Access time to your data request will be of a fixed period which will be communicated to you;
  • Data will be provided in CDISC SDTM format, analysis systems available: SAS, R.

If a special request is considered, provision of data format will be communicated to you. You will be asked to provide a publication/posting plan.

Learn more about our standards for conducting clinical trials around the world under Positions & Policies.?

US/NPR/0517/0230(1)a(1)c ?

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