How clinical trials are monitored
Clinical trials look for better ways to treat or prevent diseases and disorders. This is done, for example, by testing (new) drugs on patients or healthy volunteers (subjects) under well-controlled conditions. But it can also involve combinations of drugs, therapies or medical devices. Clinical trials are also referred to as clinical studies, (scientific) research involving human subjects or medical-scientific research on humans.
Medical research ethics committees (MRECs) and the CCMO in the Netherlands assess some 1,700 research files on an annual basis. Studies may take several years. The Health and Youth Care Inspectorate (HYCI) focuses primarily on those studies for which it expects the greatest risks. It is impossible to inspect all these studies. To determine which study must be inspected, we operate according to a risk-based approach. In addition, anyone can report a suspicion that clinical research is not being done according to the rules.
Based on risk monitoring (inspections) and incident monitoring (reports), we go to various locations for inspection visits. Aside from the Inspectorate, there are also other agencies that may play a role in clinical research.
2018-2019: clinical research in UMCs
As part of its supervisory task, the Inspectorate carried out inspections in the field of investigator-initiated research in the period 2014-2016 at the university medical centres and the NKI-AVL. The inspection will be followed up in 2018 and 2019. During the inspection, specific attention will be paid to the improvement actions that have been carried out in the field of clinical research as a result of the previous inspection. In 2020, we will publish a summary of the main results from these inspections (in a non-organisation identifiable form) on this website (in Dutch).