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.

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 pre-clinical testing, it is possible to proceed to clinical trials - studies performed in humans.

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 drug candidate is administered to healthy volunteers in very small doses. The medicines developed for serious and rare diseases, such as antineoplastics (cancer medicines), are an exception. They might be administered directly to patients.

Next, in Phase II trials, the safety and efficacy of the medicine is tested in a small patient group and the suitable dosage of the medicine is determined. Phase III trials aim at demonstrating the efficacy and safety of the medicine compared to an already marketed product or a placebo and in long-term use. Here the patient numbers are larger, even thousands of trial patients.

In order to recruit the required number of patients, several research centers, 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, how it is functioning and how to make it even more attractive.

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 trial results are analysed objectively so that the researcher performing the analysis does not know whether the patient was administered the medicine or a reference product. The information on all research and trials are recorded in a database, open for anybody to learn more about the projects.

If the trial results are positive and the benefits of the drug outweigh the possible risks, it is possible to file a marketing authorisation application for the medicine.

Click here to learn more about the clinical trials process