About clinical trials…

Clinical trials on medicinal products are carefully regulated. In Finland, the ethics of such trials is monitored by the National Advisory Board on Health Care Ethics (ETENE) and Sub-Committee on Medical Research Ethics (TUKIJA), while the National Agency for Medicines acts as the supervisory authority. In addition, the trials are regulated by the Act on Clinical Medical Trials, EU directive on clinical trials on medicinal products and data privacy legislation, for instance. Clinical trials comply with international ICH GCP guidelines (guidelines for good clinical practises) and the Declaration of Helsinki.
Good clinical practises (GCP) cover the planning, implementation, execution, monitoring, auditing, recording, analysis and reporting of clinical trials and ensure that the data and results obtained are correct and reliable.
All types of clinical trials on medicinal products are subject to a recommending statement from the Ethical Committee, and the National Agency for Medicines must be informed of all such trials.
The purpose of the guidelines, authoritative supervision and laws is to guarantee the high quality of the trials and the safety of the subjects…