Merck discovers and develops innovative drugs in therapeutic areas with high unmet medical needs. A key element of the development process for safe and effective drugs is clinical trials, which are used to test the safety and efficacy of new active ingredients in the relevant patient group.
In addition, we also carry out clinical trials after marketing authorization is received to further evaluate the safety of our drugs (pharmacovigilance). All of these trials are strictly regulated by law and must be approved by the competent authorities and ethics committees. Since patient safety is Merck’s top priority, we conduct our trials according to the highest medical and ethical standards. We comply with the respectively applicable principles of the Declaration of Helsinki and with the guidelines and applicable regulations on Good Clinical Practice (GCP) of the International Conference on Harmonisation (ICH). They apply to the various stages of clinical development, thus for studies both prior to and following the receipt of marketing authorization.
Our researchers develop the scientific structure of a study, whose entire progression is then monitored by the clinical development and drug safety departments at Merck. Our clinical trial monitors keep a close watch on the course of the study on site at the trial centers, while our global Clinical Quality Assurance unit checks the adherence to quality standards on a random basis. Every patient is informed in detail, both verbally and in writing, about the purpose of the clinical study, the experimental nature of the planned therapy, the potential benefits for participants of the study, as well as the possible risks and side effects. The investigator may commence the study only after receiving written consent from the patient.
For maximum transparency, when clinical trials begin
we publish information about the study design, the participating centers, and the patient population. In addition, the public has access to the trial results via online databases one year after the study has been completed. In this way, physicians treating patients, scientists planning research, and patients wishing to inform themselves can obtain the current state of knowledge about a particular drug or a therapeutic area. We also publish the results of research and studies in peer-reviewed scientific and medical journals.
