Clinical trials

Modern medicine is based on the principle that only proven result-bearing and safe methods can be used for treating people. Drug safety and effectiveness can be assessed in several ways, but final conclusions can only be made based on human trials. The amount of drug trials has grown year by year in Estonia, as well as in the Baltic countries. Thus, it is an increased chance for everyone that a doctor will propose participation in a drug trial.

What is a clinical drug trial?

A clinical drug trial is a controlled and rule-abiding use of a medicinal product on people to collect information on the effects, side-effects, absorption, distribution, changing and excretion, effectiveness and safety of a drug. Clinical drug trials must always receive approval from the Agency of Medicines and Research Ethics Committee.

Why carry out clinical trials?

  • Participation in clinical trials helps to develop new medicinal products.
  • Clinical trials help determine whether new potential drugs (called “investigational medicinal products”) are safe and how effective they are.
  • Clinical drug trials offer the best knowledge of decisions regarding health, new drugs and new treatment forms.
  • Clinical trials, which prove a high-enough effectiveness and safety of a drug, are necessary for every new drug to receive the authorisation for use from the Agency of Medicines.

What is the benefit for the people taking part in a trial?

  • New and additional treatment opportunity, if previous medications have not given the expected result or treatment had been discontinued due to side-effects.
  • Constant medical observation during the study.
  • Constant opportunity to contact the study doctor and nurse.

Are you suitable for participation in a clinical study?

According to the study criteria, necessary medical investigations will be carried out at the study center to assess suitability for participating in the clinical trial.
The doctor responsible for the study will explain the dangers and side-effects, as well as the treatment schedule and length of the study to you. Depending on that, you can decide whether participation is suitable for you or not.
Participation is voluntary and if you wish, you may withdraw your participation at any time. Participating in a study is free.

What are the dangers related to clinical trials?

Dangers may accompany any treatment. This also applies to carefully observed clinical studies where different side-effects may occur.

Before starting the study, the doctor will discuss with you the dangers and benefits of the study. You will also be informed of the previously known side-effects of the study drug. You have the opportunity to ask questions, take enough time to think and consider the benefit-risk ratio of the study.

Obligations of study participants

  • Taking medications according to prescription.
  • Notifying the study personnel of other illnesses and drug side-effects occurring during the study period.
  • Arriving at all scheduled visits or notifying of changes in visit times.
  • Providing information about your previous case history, if it is necessary for the clinical study.

Rights of study participants

  • You have the right to know the dangers related to the study.
  • You have the right to ask for the results of the studies related to your health known to the study center.
  • To know the contact details of the doctor responsible for the study.
  • As a clinical study participant, you have the right to withdraw from the study at any time.
  • All collected data about your health are confidential.
  • You will not receive any payout for participating in a study, but you will be compensated for transportation, parking and at some instances, for time.

 In order for the clinical study conduction to be ethically acceptable, the rights of the study participants to be protected and study results to be trustworthy, there are several rules and legal acts which handle different aspects of these studies.

You can read about the requirements of drug trials in Estonia from the Estonian Agency of Medicines webpage.