WHAT IS CLINICAL TRIAL?
DEFINITION OF CLINICAL TRIAL.
A clinical trial is a scientific activity conducted with volunteers to illuminate unanswered questions about a particular health problem. The development of new treatment methods and drugs against diseases including cancer, diabetes and cardiac diseases, which cause the most deaths in societies, is possible thanks to carefully conducted clinical researches.
In order for potential drugs, medical devices, other diagnostic/therapeutic products and methods to be made available to the public, the safety and effectiveness of these products/methods must be proven through a series of studies. These scientific studies, which are carried out with the participation of volunteers and aim to obtain medical information, are called clinical research.
In addition to researching new treatment methods/products, clinical trials can also be conducted to find a more effective way of using a known treatment method/product or to obtain more information about this method/product.
THE IMPORTANCE OF CLINICAL RESEARCH.
All the drugs we use were once put to the test in clinical trials, and thanks to clinical trials, these treatments are now saving many lives. Clinical studies with drugs are carried out to clarify the effects of the candidate substance or a treatment method on the body (pharmacokinetic effect), the effect of the drug on the body (pharmacodynamic effect), and the efficacy and safety data of the treatment. In this way, the necessary information is obtained for the delivery of more effective and safe treatments to the society. The results of each clinical study are shared by other scientists in the international arena. Thus, each study contributes to new studies, new diagnosis and treatment methods.
CLINICAL RESEARCH PRACTICE.
Who does clinical research?
Clinical trials are conducted under the chairmanship of the principal investigator, with a team that has sufficient training and experience in line with the nature of the research. The principal investigator is the physician or dentist who has completed the specialization or doctorate education in the field related to the research subject and is responsible for the conduct of the research.
Where is clinical research done?
Units where clinical research is carried out;
To ensure the safety of volunteers,
It is convenient for the research to be carried out and followed in a healthy way,
Having the necessary and sufficient personnel, equipment and laboratory facilities according to the nature of the research,
Having sufficient means and equipment to provide appropriate care services for the volunteer, including in situations where emergency intervention may be required, and to enable the volunteer to be transferred to a more advanced health institution or organization when necessary,
it should be.
It can be done in university health practice and research centers, approved research and development centers affiliated with universities, and in training and research hospitals of the Ministry of Health, preferably in places designed to conduct clinical research.
Other health institutions and organizations with the specified qualifications may be included in the clinical researches carried out in these centers and hospitals, provided that they are under the coordination or administrative responsibility of these centers and hospitals, if necessary.
Who can participate in a clinical trial?
Voluntary patients or healthy individuals may participate in a clinical trial, by obtaining the written consent of themselves or their legal representatives.
Who reviews and authorizes clinical trials?
Clinical trials are carried out with the approval of the Ethics Committees approved by the Ministry of Health and with the permission of the Ministry of Health.
Ethics Committees are independent committees established to provide scientific and ethical opinions on research in order to protect the rights, health safety and well-being of the volunteers who will participate in the research.
What are the duties of the Clinical Research Department?
The Clinical Research Department will be carried out on volunteers within the framework of international agreements and conventions, European Union standards and good clinical practices;
Clinical trials of medicinal products for human use (Phase 1, 2, 3, 4 and BY/BE),
Clinical trials of products with health claims,
Clinical studies of treatment methods, excluding stem cell, organ tissue transplantation and traditional complementary medicine applications,
Observational drug studies,
Responsible for executing the related business and transactions.
Where can I get information about the clinical trials under investigation and conducted in our country?
Information on clinical trials under investigation and conducted in our country can be accessed via the Ministry of Health Clinical Research Portal.
