Clinical trials of medicinal products
The objective of clinical trials is to demonstrate that the potential medicine is efficient and safe for its intended use.
When the research candidates developed to become a medicinal product are found to be sufficiently safe in animal testing, it is possible to proceed to clinical trials.
The detailed research plan is evaluated and approved by both the supervisory authority and an ethics committee. The Finnish supervisory authority is Fimea.
In Phase I, the medicine is administered to health volunteers in very small doses. The medicines developed for serious and rare diseases, such as several antineoplastics (cancer medicines), are an exception. They are too toxic to be administered to healthy people.
From here, the work proceeds to Phase II trials where the medicine is administered to patients and the dosage of the medicine is determined. Phase III is about demonstrating the efficacy and safety of the medicine. Here the patient numbers are larger, even thousands of trial patients.
In order to recruit the necessary number of patients, several research centres, often on a global scale, are involved in the trials with the same medicine. For a long time, Finland has been an interesting venue for clinical trials. However, during the past few years the numbers of trials have gone somewhat down, and therefore we need to pay particular attention to the Finnish research environment.
It is vital for both the treatment given to patients, the society at large and the competence of the healthcare personnel that Finland presents itself as an interesting research country, also in the future. Click here to read more about Research environment Finland.
The information on all research and trials are recorded in a database, open for anybody to learn more about the projects. The research outcome is analysed objectively so that the researcher doing the analysis does not know whether the patient was administered the medicine or a reference product.
If the outcome is positive, it is possible to file a marketing authorisation application for the medicine.
Click here to read more about the clinical trials process: