We recognize and value the critical role a research participant plays in each clinical trial as the data he/she provides, can be the foundation for tomorrow’s treatments.
We conduct our clinical trials in a manner that recognizes the importance of protecting the safety of and respecting the research participants.
In order to protect patient safety during the clinical trial process, we collect, analyze, characterize and communicate the safety data of our products on an ongoing and global basis. If applicable, we also look at information from similar drugs for potential safety signals.
We collect adverse-event reports from all over the world as part of our continuous monitoring. We promptly share new findings and emerging concerns with investigators, regulators and/or research participants to appropriately manage risks associated with the use of our medicines.
This type of communication is typically conducted via correspondence with the investigator, updates to the investigator brochure and/or updates to the informed-consent document for the clinical trials affected.
Merck KGaA, Darmstadt, Germany, requires that clinical investigators obtain and document informed consent, freely given without coercion, from all potential research participants. Participants may only be enrolled in a study after providing their voluntary informed consent.
We are committed to respecting and maintaining the privacy of research participants by ensuring that each individual’s data is deidentified in order to conceal the participant’s identity. We safeguard the confidentiality of each participant’s medical information in accordance with all applicable laws and regulations.