A clinical trial includes human volunteers and serves to answer a specific medical question. Carefuly conducted clinical studies are the fastest and safest method to discover new treatments or ways to improve human health. Interventional studies investigate whether experimental treatment (or standard treatment applied in a new way) is safe and effective under controlled conditions, while observational studies investigate the health problems of large populations of people in natural conditions.
Each individual study has specific criteria which define the patients who may participate in it. The use of inclusion and exclusion criteria is an important principle of medical research that ensures the reliability of the final results. The factors that allow the patient to participate are the inclusion criteria, while the patient who has some of the exclusive criteria is not a candidate for participation in the study. These factors may include age, sex, type and stage of the disease, previous treatment, and other medical conditions / illnesses. Some studies include patients with a specific disease, while other studies include healthy individuals. It is important to note that the inclusion and exclusion criteria are not defined to prevent the inlcusion of patients in the study on a personal level, but to identify groups of patients who have the highest chance of treatment success and to ensure the safety of therapy. Also, well-defined inclusion and exclusion criteria allow the study team to get a clear answer to the question posed by the study.
It is always a good idea to gather enough information about the clinical study before deciding to participate, and to clarify any concerns you may have with the doctor who is conducting the study. All important issues are also clarified in informed consent, which must be signed by the patient before the study starts. Some of the important questions that should be answered are:
- What is the purpose of the study?
- Who will be included into the study?
- Why do researchers believe that the new drug being tested could be effective?
- What diagnostic tests and treatment will be performed/given to the patient?
- What are the possible risks, side effects, and benefits of the new drug?
- How can participating in a clinical study affect my daily life?
- How long will the study take?
- Will hospitalization be required?
- Who will pay for the treatment in the study? Will my expenses be covered?
- Is there any form of patient follow-up after the study is completed?
- How do I know if a study drug is working? Will I get the final results of the study?
- Which study team will take care of me?
Clinical studies can be sponsored by a variety of organizations or individuals, such as physicians, healthcare institutions, groupations, volunteer groups, and pharmaceutical companies, as well as some government agencies. Likewise, studies can be conducted in a variety of medical institutions, such as hospitals, colleges, offices and clinics.
