Do I have to pay anything?

Participation in a clinical study is free, your expenses related to examinations and medication are covered by the clinical trial sponsor. In some cases, the patient even gets financial or meal voucher compensation for their travel expenses.

Does the participation have to be approved by my attending physician?

No, the clinical study participation is voluntary and based solely on your decision. Your attending physician does not need to approve your participation in the study. However, it is advisable to inform your physician about your participation. The study investigator always decides on participation in the clinical trial, based on entry criteria clearly defined by the protocol (e.g. diagnosis, age, sex, additional diseases).

What are the risks of participating in a study?

All the known risks related to the administration of the tested drug are listed in the written study information. It is crucial that the patient informs the physician about any problems they might be having in time. Only then can the advancement of possible complications be prevented. Safety is monitored throughout the study. Each investigating physician is obliged to report any “serious adverse event” within 24 hours – even an unplanned admission to a hospital, regardless of its relation to the administered study medication.

The State Institute for Drug Control continuously evaluates all received reports and if there are any doubts, it can interrupt or discontinue the study. At the same time, the risk-benefit assessment is performed prior to the study initiation. If the risks exceed the benefits, the study will not be allowed. Maximum measures are taken to prevent the study participant’s exposure to excessive risk which, however, can never be ruled out completely.

Why participate?

The main advantage is the possibility of treatment by new drugs or drug combinations not yet available outside the study. It is assumed that the new drug (or drug combination) will be more effective than the standard available treatment or that with the same efficacy, there will be a lower risk of adverse effects.

In randomized studies (studies with random group assignment) that compare two (or more) treatment methods, it cannot be determined in advance what type of treatment will be assigned to the patient. When deciding on study participation, it is necessary to account for the possibility you may be assigned the “standard” treatment or placebo treatment. This method is necessary for determination of drug efficacy in some clinical studies.

In drug testing, patient safety is always a priority. For this reason, the protocol usually requires above standard patient monitoring in order to ensure that any deterioration of the disease or adverse effects are established sooner, regardless of the type of treatment (investigated drug versus “standard treatment” or placebo) selected.

If your physician advises you to participate in a study, they should explain the reasons of the study to you, as well as what you should expect from the study. They must provide written study information to you. The text is approved by the Ethical Committee and the State Institute for Drug Control. This information must include all the known risks and benefits of the treatment, describe the examinations performed and treatment methods applied.

Consider your participation in the study carefully. Talk to your family and friends, don’t be afraid to ask the physician, if you have any questions. Compare the standard treatment possibilities to the study treatment. Check how frequent your appointments will be. It is important that you are able to meet the requirements of the study protocol.

Participation in a clinical study is VOLUNTARY and FREE, your expenses related to examinations and medication are covered by the clinical trial sponsor. Initiation of drug or treatment testing is conditioned by a signature of an approved informed consent of the patient. You have the right to revoke your informed consent anytime and without giving a reason and terminate your participation in the study.

A clinical study participant is always protected by ethical principles incorporated in the EU legislation, i.e. the Nuremberg Code, the Declaration of Helsinki, Good Clinical Practice and the legislation of the Czech Republic.