Ethical principles of all clinical studies

All clinical studies in which patients are included must comply with the standards and principles of Good Clinical Practice and the guidelines of the Declaration of Helsinki.

Definition of Good Clinical Practice

GCP is an internationally recognised ethical and scientific standard for the planning, conduct, documentation and reporting of clinical investigations involving humans. Compliance with these standards ensures that the rights, safety and well-being of participants in clinical investigations are protected and that the results of the trials are credible and reliable. Digitalisation can also be used disruptively in clinical studies to improve the patient experience, increase efficiency and improve data quality.

The GCP was drawn up in 1996 by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and forms the basis for many national and international laws and guidelines. In the European Union (EU), these principles were introduced by EC Directive 91/507/EEC and later further specified by Directive 2001/20/EC and Directive 2005/28/EC.

For medical devices, the principles of GCP are regulated in ISO14155, Regulation (EU) 2017/45 and 2017/746. There are also other national laws in which these principles are enshrined.

Ethical principles for medical research

The Declaration of Helsinki was developed in 1964 by the World Medical Association (WMA) as an important ethical policy document for medical research involving human subjects. It is regularly revised in order to adapt it to new ethical challenges in medical research. It serves as an important guideline for researchers, ethics committees and regulatory authorities worldwide. The Declaration of Helsinki and GCP set out ethical principles that ensure that the rights, safety and welfare of trial participants are paramount.

If clinical studies do not meet the standards of Good Clinical Practice (GCP) and the Declaration of Helsinki, serious consequences can occur.

The consequences include

• Violation of legal and criminal law requirements
• Interference with people's fundamental rights
• Endangering people at risk of illness
• Endangerment of people who need special protection
• Damage and violation of the rights, safety and well-being of study participants
• Lack of recognition of study data for medical devices and medicinal products
• high costs due to the possible need to repeat a clinical study
• Loss of trust from the public and the scientific community

A clinical contract research organisation should competently support manufacturers of medical devices in the GCP-compliant design, conduct and evaluation of studies.

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Pleasecontact us to check whether a study design or protocol complies with these and other international regulatory requirements.