INFORMING PATIENT and FAMILIES

CONTENTS

1. What is a Clinical Trial?

• Interventional studies
• Observational studies

2. Who Conducts Clinical Trials?

3. Who Funds Clinical Trials?

4. Where are Clinical Trials Conducted?

5. How Long do Clinical Trials Take?

6. Why are Clinical Trials done?

7. Where Can We Learn Clinical Trial Content Information?

• Who Can Participate in a Clinical Trial?
•  How Are Volunteers Informed?
• How are Volunteers Protected?
• What are the Questions to Ask the Research Team?

1. What is a Clinical Trial?

Clinical trial is scientific research conducted with the contributions of volunteers aiming to contribute to medical knowledge. Participating in clinical trials contributes to medical knowledge and it requires purely volunteerism. The results of these studies provide information about the benefits and risks of the drugs or related products and medical devices.

There are two main types of clinical trials, named interventional and observational.

• Interventional studies

In interventional clinical trials, an intervention is created by the investigators and only the interventions determined in the trial protocol are carried out. These interventions can be drugs, medical devices, medical products or medical methods.

In interventional clinical trials, a new medical practice can be compared with an existing standard practice, a non-intervention approach or placebo (a product that does not contain active ingredient, however looks like an investigational product/ a product that does not have beneficial medicinal ingredients)

When examining a new product or method, the effects and results of the practices are measured on volunteers.

• Observational studies

Volunteers continue to receive their usual routine medical treatment. As in interventional clinical trials, interventions determined by the investigator are not applied. Investigators evaluate the current situation of the volunteer according to the research protocol.

For example, researchers could monitor the current status of a group of older adults to learn more about the effects of different lifestyles on heart health.

2. Who Conducts Clinical Trials?

Clinical trials are conducted by a principal investigator who is a medical doctor or dentist. The research team also includes doctors, nurses and/or other health professionals.

3. Who Funds Clinical Trials?

Clinical trials can be supported by pharmaceutical companies or national health institutes or research supporting institutions (such as the Scientific and Technological Research Council of Turkey, Presidency of Turkey Health Institutes) and other organizations. Physicians and other healthcare providers may also sponsor clinical trials.

4. Where are Clinical Trials Conducted?

Clinical trials can be conducted in faculties of medicine, training-research hospitals, research and development centers affiliated with universities, and preferably in places designed for clinical trials and approved by the Ministry of Health, which should have personnel and equipment laboratory facilities suitable for the nature of the research, ensuring the safety of the volunteers.

5. How Long do Clinical Trials Take?

The duration of a clinical trial varies depending on the trial protocol. Before starting the clinical trial, the volunteers are informed about the duration of the trial.

6. Why are Clinical Trials done?

Clinical trials are conducted to contribute to medical knowledge regarding the prevention, diagnosis and treatment of diseases.

Some of the reasons for doing clinical research are:

•   Finding ways to prevent the development or recurrence of a disease or complaint,

•   Identifying a disease or signs of illness, to evaluate the risks and benefits of applications developed for diagnosis and treatment (drugs, medical devices, surgical methods or radiation therapy, etc.).

•   To identify risk factors associated with a disease.

•   Exploring and enhancing ways to improve comfort and quality of life through supportive care for people with chronic illness.

7. Where Can We Learn Clinical Trial Content Information?

Clinical trials are conducted according to a research plan known as a "protocol". The protocol is designed to answer research questions and protect participants' health.

The protocol includes information such as the reason for the research, who can participate in the study, how long it will take, the number of volunteers required for the study, what information will be collected from the volunteers, the dose, time and route of administration of the tests, procedures or drugs and the benefit/risk status.

• Who Can Participate in a Clinical Trial?

There are standards that determine who can participate in clinical trials. These standards are called “eligibility criteria” and these criteria are specified in the research protocol/plan. Some studies involve healthy volunteers, and some studies include patients.

Volunteers should meet the conditions predetermined in the protocol. Criteria must be specified such as "hypertensive male patients over 50 years old will be included in the study"

Those who meet these criteria are included in the study, while those who do not are not included in the study.

• How Are Volunteers Informed?

Volunteer candidates are initially informed about the details of the trial. Bu amaçla For this purpose, the "Informed Consent" process is used. The informed consent process aims to inform participants, helping them understand the risks, potential benefits, and alternatives of the study.

If the volunteer agrees to participate in the study, they must sign a clinical trial-specific “informed consent form” to declare that they have been informed and have understood the risks, potential benefits, and alternative treatment options prior to participating in the trial.

Signing the document is not a contract. Volunteers can leave the study at any time and without giving any reason, even if the study is not completed yet.

• How Are Volunteers Protected?

In order to conduct scientific research on humans and for the protection of volunteers' rights,  clinical trials should be carried out in accordance with the Good Clinical Practices (ICH-GCP) prepared within the framework of the European Union Standards, the Regulation of the Ministry of Health on Clinical Trials of Pharmaceuticals and Biological Products, related legislations and ethical principles.

Ethics Committees are independent committees, established to provide scientific and ethical opinions about the research in order to ensure the rights, health, safety and well-being of the volunteers who will participate to the research. Studies can be carried out after the approval of the ethics committee and the Ministry of Health.

In order to determine whether the criteria for inclusion in the study are met, the current health status and the drugs used should be reported to the research team. If participation in a clinical trial is deemed appropriate, treatments for existing health problems should be taken.

The candidate should know as much as possible about the study and should feel comfortable for asking the research team questions about the study.

• What are the Questions to Ask the Research Team?

The following questions can help you get detailed information about the clinical trial you are considering to participate in. The answers to some of these questions are provided in the informed consent document. Many of the answers are specific to the clinical trial to be conducted.

•   What is being studied?

•   Has it been tested before? Why is it believed to be more effective?

•   What are the possible tests or practices that will be perfomed on me during the trial?

•   How will the interventions be determined?

•   Who will know which interventions have been performed?, Will I know it?, Will members of the research team know?

• If a product that does not contain an active substance is applied and my disease worsens, will it be intervened?

•   What are the possible risks, side effects and benefits of the new intervention compared to the current treatment?

•   What will I need to do?

•   How often will I need to visit the hospital or clinic?

•   Will hospitalization be required?

•   How long will the trial take?

•   Who will pay the treatment/intervention costs?

•   Will the expenses (such as travel, accommodation) that will arise with my participation in the trial be reimbursed to me?

•   Do I need to be followed for a long time?

•   If I benefit from the intervention, will I be able to continue receiving the investigational product after the trial ends?

•   Will I be able to learn the results of the trial?

•   Who will control my medical care while participating in the study?

•   What to do if I am injured while working? Will there be an insurance?