Advances in medicine and science are the result of new ideas and new approaches that are developed through research. A clinical study is one of the final stages of the research process. Almost all medications that are now available from doctors for various medical disorders have had to go through clinical studies to demonstrate that they will help patients, having proven their safety and efficacy, before they can be made available through prescription to the public.

Why do patients participate in research?
Although remarkable progress has been made in defining and treating psychiatric disorders, some treatments are not effective for everyone or may have significant side effects. Because of this, most people who agree to take part in studies hope the research will produce knowledge about the disease itself and further treatment options.  Participation is always voluntary and should occur after proper consideration of all facts available.

What can a participant in a clinical study expect?
Before a person enters a clinical study, the doctor (known in a clinical study as "Investigator") will fully describe the purpose of the study, what is expected from the person as a participant, what they will provide the person with (tests, medicine etc.), and why the study might be of benefit to the person. All of this information is outlined in the Informed Consent form.

The most important part of participating in any clinical study is the safety of the patient. The patient must follow all instructions given by the team, such as taking medication as directed, attending all visits as needed, and accurately answering all questions related to study medication and the patient's health.

What is "informed consent"?
The Informed Consent form (a written document that is given to the patient to read and sign) is to confirm the individual's participation on a voluntary basis and is required before the person can take part in the study. The patient must read and sign the consent form voluntarily if the patient wishes to participate (only after the patient has understood all the points, including risks and potential benefits, and had all questions satisfactorily answered). The study physician will also sign the consent form and a copy will be provided to the patient.

In the case of children (and handicapped or very ill individuals), the written consent of their representative or legal guardian is required, as well as the assent of the patient (as in the case of a child) when applicable.

What are the rules governing the conduct of clinical studies?
National laws govern the proper conduct of clinical studies and the protection of participants. In addition, various strict ethical and technical guidelines have been adopted at national and international levels. One of these is Good Clinical Practice (GCP), which provides further protection of the participant in clinical studies. One of the main principles of GCP states, "the rights, safety, and well-being of the study subject are the most important considerations and should prevail over interest of science and society".

What is a placebo?
Studies of new medicines often compare the effects of the investigational medicine with those of a placebo (sometimes described as a "sugar pill"). A placebo looks like the investigational medicine but contains no medically active ingredient. It is used to assess the effectiveness of investigational medicine by acting as a control.

Participant data confidentiality
The clinical study's sponsor and the authorities must have explicit permission from the individual participant to have access to his/her medical files (this is part of the written informed consent). All documents containing details of a subject's identity are filed exclusively at the Investigator site. These details are not shared with the study sponsor or regulatory authorities.