Clinical studies - initial knowledge

Clinical studies are scientific investigations carried out on humans to research the safety and effectiveness of new medical treatments, drugs or procedures.

Clinical studies are necessary when existing data cannot prove the safety, effectiveness, benefit or risk-benefit ratio. This is the rule for new products.

In clinical studies, we distinguish between clinical investigations under the German Medicines Act, clinical investigations under the EU Medical Device Regulation (MDR (EU) 2017/745), performance studies under IVDR (EU) 2017/746 and studies with food supplements, cosmetics or purely scientific studies, e.g. to gain knowledge.

Important points for clinical studies are:

Types of clinical studies:

• There are different types, including treatment studies, prevention studies, screening studies and diagnostic studies.
• They can also be divided into observational studies and interventional studies.\

Phases of clinical studies:

• Clinical studies usually go through four organisational phases, with each phase having specific objectives. These include: Design, execution/planning, implementation and evaluation.

• Careful design is the basis for the success of a clinical study.\

Participants:

• Both healthy volunteers and patients with certain diseases can participate in clinical studies.
• Participation is always voluntary.\

Ethics and safety:

• Clinical studies are subject to strict ethical guidelines and safety regulations.
• They must be authorised by ethics committees and, if necessary, supervisory authorities.\

Significance:

• Clinical studies are crucial for the development of new treatments and the improvement of medical care.

• They form the basis for evidence-based medicine.\

Implementation:

• Clinical studies follow a detailed protocol that defines the procedure, objectives and methods of the study.
• Only if they comply with the previously defined protocol can their results be recognised.\

Results:

• Only verified reliable results are credible and recognised by scientists, authorities and health insurance companies.
• The results of clinical studies are often published in medical journals and can influence medical practice.

In addition to the precise assessment of an innovation and its classification as a medicinal product, medical device including risk classification, dietary supplement or cosmetic, other factors must be taken into account from the outset.

These include knowledge of previous data, assessment of the market and thus the demand, the state of the art, existing therapy options and guidelines. Only then is the time-consuming work of planning a clinical study with a relevant research question to prove efficacy and benefit or additional benefit worthwhile.

Other important factors that need to be considered in advance are the required level of evidence, the clear assessment and positioning of an innovation or the selection of a relevant indication area in order to ensure reimbursement by health insurance companies or patients.

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