Clinical trials

In our quest to thoroughly understand our pharmaceutical products throughout their entire life cycle, we ensure that patient needs are foremost at all times.

We conduct top-quality clinical research in compliance with the applicable laws and regulations. When conducting multinational, multi-site trials in both the industrialized as well as developing world, we follow the highest legal, ethical and scientific standards.

Merck KGaA, Darmstadt, Germany only conducts clinical trials if a sound, proven scientific methodology is used to investigate a scientific or medical question of relevance to patients, medical professionals, and society as a whole. We only enroll the number of participants required to answer the scientific questions being investigated.

Adhering to the highest standards

In all its research and development activities, Merck KGaA, Darmstadt, Germany adheres to the most stringent legal, ethical, scientific, and quality standards. These include:

1. The Good Clinical Practice (GCP) guidelines  of the International Conference on Harmonisation (ICH)
2. The Declaration of Helsinki of the World Medical Association
3. Good Laboratory/Manufacturing/Clinical/Distribution Practice (GLP/GMP/GCP/GDP)
4. "International Ethical Guidelines for Biomedical Research Involving Human Subjects " of the Council for International Organizations of Medical Sciences (CIOMS)
5. The “Joint Position on the Disclosure of Clinical Trial Information via Clinical Trial Registries and Databases ” and the “Joint Position on the Publication of Clinical Trial Results in the Scientific Literature ”, issued by the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA), the European Federation of Pharmaceutical Industries and Associations (EFPIA), the Japanese Pharmaceutical Manufacturers Association (JPMA), and the Pharmaceutical Research and Manufacturers of America (PhRMA).

The principles of these and similar reference standards have been translated into legal requirements through laws and regulations that are enforced by national health authorities.

Merck KGaA, Darmstadt, Germany frequently works in partnership with third parties to provide a broad, in-depth basis for our pharmaceutical development. We expect and check that all our partners – especially contract research organizations (CROs), licensing partners and suppliers – abide by the same set of standards for conducting clinical trials.

Clinical trial governance

The Head of Global Discovery and Early Development and the Head of Global Drug Development and Medical, supported by the corresponding Operating Committees, have overall responsibility for product development and the related governance process. Our Medical Safety and Ethics Board (MSEB) makes decisions on product safety issues in order to ensure that patients’ interests are being optimally served. This board, chaired by the Head of Global Drug Development and Medical as well as by the Chief Medical Officer, consists of senior physician and scientists.

Conducting clinical trials responsibly

Every clinical trial participant is important to us – both as a person and as a source of scientific findings for the treatments of tomorrow. In conducting our clinical trials, we bear in mind the great importance of trial participant safety. Prior to enrolling a single subject in an interventional clinical trial, a qualified independent ethics committee/institutional review board (EC/IRB) must therefore review and approve each and every trial. All local regulatory or governmental authorizations required in the respective country must furthermore be obtained. Before accepting participants into a clinical trial, we first ensure that they have been properly informed about the potential risks and benefits, about alternative processes or treatments, and about the nature and duration of the clinical trial. They can ask questions about the trial and get answers from a qualified healthcare professional associated with the study.

Once a trial starts, procedures are followed to ensure that the study is conducted in accordance with Good Clinical Practice and that the data are accurately generated, documented and reported in compliance with all applicable requirements. We continuously collect, characterize and communicate the safety data for our products, promptly sharing new findings in order to appropriately manage the use of our pharmaceutical products. In addition to this, we safeguard the confidentiality of each trial participant's medical information in compliance with the applicable laws and regulations. Merck KGaA, Darmstadt, Germany transparently communicates information on its clinical trials in accordance with international transparency agreements.

Conducting clinical trials in developing health care systems

Regardless of location, Merck KGaA, Darmstadt, Germany conducts all its clinical trials in compliance with internationally agreed scientific and ethical standards, in addition to the locally applicable laws and regulations. Historically, the pharmaceutical industry has focused its development activities in the United States and Europe. However, the vast majority of the world's population resides outside these regions. Merck KGaA, Darmstadt, Germany is actively shifting its development activities to more diverse markets in order to address the health care needs in these regions as well as to support the development of their health care systems. In performing clinical trials in these developing health care systems, we apply the same principles there (sound methodology; importance of issue under investigation; quality and monitoring) that we would apply when conducting such trials in a developed health care system. When we conduct clinical trials in a developing health care system

1. We only do so in an environment that can follow Good Clinical Practice (GCP), meaning one that has appropriately set-up ethics committees and well-trained Clinical Investigators.
2. We only address diseases and test innovative medicines that are relevant for the local population.
3. We conduct clinical trials in countries where there is a reasonable expectation that the drug tested will be submitted for marketing authorization and be made available to patients/subjects after proof of efficacy and safety.
4. We also assure that enrollment into a clinical trial does not discriminate against participants on the basis of ethnic origin, gender or socio economic status.