A clinical drug study is the use of a drug in humans to collect data about the drug’s effect, adverse reactions, absorption, distribution, transformation, efficacy and safety. The conduction of the studies in the Regional Hospital is done according to present-day requirements. All the studies will be approved by an independent ethics committee and if required by the State Agency of Medicines beforehand. This guarantees the best protection of the participating patients.
Four phases of human drug studies
- The aim of the first-phase studies is to evaluate the drug’s pharmacokinetics – how the drug gets into the body, distributes, transforms there and how it is excreted. The first studies are usually performed in healthy volunteers.
- The aim of the second-phase studies is the investigation of the effect and safety of the drug in a relatively small number of patients to ascertain if the drug even has the expected therapeutic effect and to find a suitable dose.
- In the third-phase studies a higher number of patients is included to prove the positive benefit/risk ratio of the drug, i.e. the benefits from the drug outweigh the harm caused by possible adverse effects.
- The fourth-phase studies are performed after the drug is approved for testing with the aim of evaluating the effect of long-term use of the drug and its place among other treatment methods.
Participation in the studies
- Participation in the study is voluntary. The study doctor introduces the study to the patient and if the patient is suitable and consents, a written agreement will be concluded for participation in the study. During the clinical study a treatment will be initiated or changed according to the study protocol or different diagnosis methods are applied.
- The personal data of the study participant and information obtained during the study are confidential and will not be disclosed to people who are not authorised to get this information.
- It is important to follow the rules established by a specific study protocol. Among other things the study protocol determines when the visits to the doctor’s office occur, analyses and other procedures are done and how the drugs should be taken during the study.
Each year about one hundred drug studies are performed in the Regional Hospital. You can find information about the drug studies in progress in Estonia on the webpage of the State Agency of Medicines.
Process of initiating a clinical drug study
Contact
With questions concerning the clinical drug studies in progress or the initiation of a study please contact the Research and Development Department:
tat@regionaalhaigla.ee