CLINICAL DEVELOPMENT

 

Clinical trials and studies.

People count on us to make medicines and vaccines that have well documented safety and effectiveness profiles and offer value. Clinical trials (also known as clinical studies) are a critical step in this process.

Before they may receive approval for use, medicine and vaccine candidates undergo rigorous and systematic testing by volunteers. This process is designed to evaluate whether a new product should be approved for use in the broader population. Each clinical trial is designed to answer certain research questions. They follow strict, predefined protocols to ensure safe and accurate results. Each phase has a different purpose in the development of a medicine or vaccine: ​

  • Phase I: Researchers test an experimental drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine an appropriate dosage, trace what happens to the compound in the body, and begin to identify side effects.
  • •Phase II: The drug or treatment being studied is given to a larger group of people with the disease (100-300) to obtain preliminary evidence of an effect and to further evaluate its safety. If there is evidence of an effect and the risks are considered acceptable, the drug may move to the next stage.
  • •Phase III: This phase of trial tests a drug candidate in a larger number of people with the disease (1,000-3,000), further testing its effectiveness and monitoring for side effects. In some cases this will be compared to a treatment standard, if one is already available.
  • •Phase IV: After a drug or treatment has been approved by the appropriate government and regulatory agencies and is being marketed, we may study its safety and effectiveness over a longer period of time and in a larger number of people. We may also continue to study some of our marketed products for new indications. Thousands of people usually participate in Phase IV trials.
  • At MSD, our clinical trials are designed, conducted and monitored in adherence to the same standards, whether they take place in the United States or elsewhere around the world. In conducting clinical trials, we also adhere to the guidelines of The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use.

    Medical Affairs in Belgium

    MSD's medical activities in Belgium focus on four main areas, to generate and communicate the scientific basis behind MSD's medicines and products, and to contribute to safety and appropriate use. The department also works closely with Marketing, providing ethical medical and scientific approval on marketing materials.

    The department consists of the following teams:

    Clinical Research Operations

    This team aims at obtaining regulatory approval for clinical trials, and conducts these trials to evaluate the tolerability and effectiveness of our products. These trials are fundamental to the development of innovative medicines and vaccines that treat and prevent illness.

    Regulatory Affairs

    This team is responsible for activities associated with marketing authorisations (submission of new applications, variations and life cycle management) and controls approved prescribing information.

    Pharmacovigilance

    One of the most important missions of Pharmacovigilance is to ensure the safety, efficacy and quality of medicines. The objective of Pharmacovigilance is to continuously search for improvement of the benefit-harm-risk profile for medicines under development and medicines already available on the market.

    Pharmacovigilance is a highly regulated domain within the pharmaceutical industry on national, European and international level. Respecting Pharmacovigilance recommendations and guidelines are essential to guarantee the patient's safety.

    If you wish to inform us about (an)undesirable adverse effects, please contact us via this e-mail: dpoc_belux@merck.com. In case of emergency (during the week-end or public holidays), please call free 0800/38 693.

    Medical and Scientific Affairs

    This team provides medical and scientific guidance, support and resource to the company (e.g. Marketing, Sales, Sales Training, External Affairs) and to health care professionals. It supports the company to remain compliant with the ABPI Code of Practice and similar, and provides scientific advice / decision-making regarding medical and educational goods and services, investigator initiated studies and local interventional and non-interventional studies.