• Patients do not pay for trial visits, procedures or medicines.
• Patients are reimbursed for costs of travelling to visits.

Placebo is name for a substance that is biologically neutral and cannot affect our health or functioning. “Placebo effect” is a situation when a patient who has taken a substance that is not a medicine gets better. Placebo can be used to treat people only in strict compliance with specific rules set out in the Declaration of Helsinki, as well as directives of the European Union and the World Health Organization.

A patient who wants to join a trial has to carefully read the Informed Consent Form to Participation in a Clinical Trial. The form includes detailed information on the trial, procedures performed during the trial, potential benefits and risks related to the investigational product taken by trial participants. The investigator, also called the study doctor, resolves all doubts and answers all questions about the trial and trial procedures that a patient may have. A patient may join the trial only after the Informed Consent Form has been signed.

Any medicine that is to be approved for sale and use in patients must successfully complete clinical trials. During different phases of clinical trials, product efficacy and safety are evaluated and the optimum dose is determined. What is more, clinical trials help develop new methods of treatment and prevention of diseases and their complications. Clinical trials are a foundation for the development of pharmaceutical and medical sciences.

Detailed guidelines for a specific clinical trial and any related procedures are included in the trial protocol. Each team member involved in a research project must strictly follow the protocol. A protocol is a research plan developed to answer specific research questions and to ensure the safety of trial participants. Its objective is also to ensure the appropriate quality of the collected data.

• An innovative medicine or treatment method may or may not bring the expected benefits, which means that the health of a participant may not improve.
• When being in a randomized trial (where patients are randomly assigned either to the treatment group or placebo group), patients cannot choose what treatment they will get.
• We do not yet know all negative effects of a medicine or new therapy – adverse events may occur and that is why the monitoring/follow-up of patient health and close cooperation with the site staff are so important.
• We do not yet know all negative effects of a medicine or new therapy – mild, moderate or severe adverse events may occur and that is why the monitoring / follow-up of patient health and close cooperation with the site staff are so important.

The most important rights of a clinical trial participant include:

• A patient has a right to receive all information related to the participation in a trial. If the information is not clear, the patient has a right to obtain clarifications from the doctor and his/her staff.
• A voluntary consent of the patient to participate in a trial is necessary, but the patient has a right to refuse to participate.
• The patient has a right to withdraw from a trial at any time, without any penalty.
• The patient has a right to be informed on his/her health at any time during the trial.
• The patient has a right to have his/her personal data protected.

Clinical trials are closely monitored – to ensure the highest level of safety for the patients as well as the quality, integrity and reliability of the collected data. To ensure that, each person involved in the project must comply with strict rules of Good Clinical Practice and have relevant qualifications and training.

Clinical trials are conducted in compliance with strictly pre-determined rules, in line with the requirements which are set out in detail in Polish laws and international regulations. Designated institutions oversee the regularity of the conduct of clinical trials in Poland.

Before a trial starts at any site, first an Ethics Committee has to approve and issue a positive opinion on the trial. The President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products must also give consent to the initiation of the clinical trial after reviewing the submitted trial documentation.