All licensed medicines that have been put into the service of humanity and have been sold must undergo these experimental and clinical trials. Today, it is possible to treat many diseases which are the problems of humanity with the drugs that are obtained from the information obtained from these clinical studies.
The decision to participate in a drug trial is an important individual decision. Below are many frequently asked questions about drug clinical trials in ARGEFAR Clinics I and II. In order to make such a decision, we recommend that you consult your doctor, family members and / or friends in addition to the following information and ask for their opinion and assistance.
1 - What is clinical research?
It is inevitable that candidate products, which may be pharmaceuticals, should be subjected to clinical studies with limited and framed human beings under the supervision and supervision of adequate and competent researchers before they are presented to the broad public.
These drug candidate product studies on humans are called “Clinical Studies.. Clinical research in humans is the most valid, fast and safe way to develop new drugs and therapies to improve human health. The necessity of carrying out these researches was developed by pharmaceutical companies.
The aim of these four-step researches is to prepare the most detailed and detailed information about the efficacy and safety of the drug candidate product in the patients and / or healthy volunteers selected by qualified researchers in the field and within the scope of a pre-designed and determined plan and program under the supervision of competent and responsible researchers. is to obtain.
A “Clinical Study” decision requires a long process. Previously obtained information about the investigational product at each step should be sufficient and scientifically proven for the next step. A text called “Research Protocol hazırlanan, which is prepared in the framework of this information and contains the details of each step and all the procedures to be applied during the research, is created. A research center with the most advanced facilities offered by the technology that will allow the execution of this protocol, which includes all the details about the research, and a responsible researcher and assistants who can implement this protocol are selected.
This group of investigators submits this protocol and any forms in the annex to which it is to be recorded and an application form attached to the information of the investigational product in order to obtain permission from the relevant authorities in accordance with regulations and guidelines. Clinical trials may only be carried out under the conditions approved by these authorities.
2 - What are the stages of clinical research?
Clinical trials are carried out in 4 steps with different purposes.
Stage I research: The aim of this study is to investigate the safety of new drugs, to determine the adverse effects and to test the small dose range of 20-80 people.
Stage II studies: It is applied to larger groups of 100-300 people to investigate the efficacy and safety of the drug.
Stage III studies: It is applied to large patient groups of 1000-3000 people to investigate the efficacy and safety of the drug.
Stage IV studies: These are the studies that are carried out to reveal the most appropriate use, benefits and risks of the drug after it has been licensed and released.
3 - What is bioequivalence study?
There are many drugs on the market that contain the same active substance but are produced by different companies. The drug of the company that first launched the drug is called al original drug,, while the drugs of other companies are called erik generic drugs ilaç. Although generic drugs contain the same active substance as the original drug, it may not have been proven whether many of their therapeutic powers are equivalent to the original drug. The blood levels of these generic drugs, which are generally determined after single dose administration to healthy volunteers, can be compared with the blood levels obtained after the administration of the original drug, which is generally performed as a single dose.
These studies are called “bioequivalence research”. Briefly; The aim of this study is to evaluate the blood levels of drugs containing the same amount of the same active substance and to determine whether they have the same efficacy. Etkin The active ingredients of the drugs used in the researches are definitely available in the Turkish pharmaceutical market and can be obtained from pharmacies.
4 - What is PHASE I study?
Phase I studies are the collection of product safety data, determination of the dose range, and the tolerable dose and pharmacokinetic properties of 20-80 people in healthy volunteers. The main purpose of this phase is 'safety'. Phase I studies can also be performed on patient volunteers in some cases.
5 - How to conduct clinical trials?
First of all, volunteers who are called to the clinic for the study are given detailed information about the study under the name of ‘Information Meeting‘. If any questions are answered. They are then asked to carefully read, fill out and sign the ‘Informed Volunteer Consent Form ılan which is distributed to them. Only after this stage can the screening examination be initiated. All examinations and laboratory findings of the volunteers who are screened for health are evaluated and the data obtained are transmitted to them. Volunteers who were selected to participate in the study should be present at the clinic for hospitalization one day before the administration of the drug. The next morning, between 10 am and 9 am, usually a 10-hour post-hunger research drug is administered.
According to the research protocol, breakfast can be served as required. Blood samples are taken from volunteers at pre-determined intervals before and after drug administration. In some cases, the subject is allowed to leave the clinic at the 12th hour (20:00 pm) following the administration of the drug, but under the circumstances, the volunteer may be required to stay in the clinic for one or more nights under certain conditions. Again, according to the protocol, volunteers may need to come to the clinic and give blood on the other days after taking the drug.
Bioequivalence studies generally consist of two application periods (Bioequivalence studies consisting of four separate application periods). The period between the application periods is at least 1 week (a period varying according to the protocol) and this period is necessary for the body to be completely cleaned from the drug. Volunteers are admitted to the clinic for the second period. The processes applied are the same as in the first application period. At the end of the study, the volunteers are given a final examination and laboratory tests.
Phase I studies are usually the only application period and volunteers who complete the clinical hospitalization period continue to come to follow-up visits within the period specified in the study protocol. At the end of the study, the volunteers are given a final examination and laboratory tests.
6 - How to participate in a clinical trial?
Each clinical trial has its own “inclusion” and “exclusion” criteria. These are important principles for achieving acceptable results from clinical trials. Inclusion criteria specify the conditions for the volunteer to participate in the study, while exclusion criteria specify the characteristics that the volunteer should not have.
These criteria may be related to age, sex, type of disease, prior treatment, habits or physical characteristics. After a thorough investigation and examination including physical and laboratory tests, it is recommended to participate in this study if the individual is found to be eligible.
7 - What to do before you participate in a clinical trial?
Volunteers invited to the clinic for health screening are provided with detailed information about the study. Volunteers who want to participate in the study sign the miş Informed Volunteer Consent Form..
After signing the Informed Consent Form, a detailed physical examination and laboratory tests (blood and urine) are performed before the clinical trial. Electrocardiography (ECG) of the volunteers are taken and blood pressure, pulse and body temperatures are measured. Height and weight measurements are made and evaluated for their suitability.
No cost related to all the examinations, tests and medications to be used is charged to the volunteers.
8 - What is the informed consent form?
Any information available on the product to be applied before accepting the proposal to participate in the research, its possible benefits and hazards, what will be done during this application and their possible hazards, how many individuals will participate in this study, and so on. içeren Informed Volunteer Consent Form hazırlanmış which is prepared in a way that the volunteer can understand, which includes the information in detail, is given to the individual by taking into consideration the time required for reading and making a free decision.
It is also stated who can answer the questions in mind in the decision-making process and all kinds of conditions are provided for making the decision within the framework of voluntariness without any effect and pressure.
9 - How to ensure the safety of volunteers in clinical trials?
The clinical trial to be conducted is absolutely approved by the Ministry of Health and Ethics Committees. Each researcher has a research protocol containing a work plan indicating the obligations of the researcher and the research is conducted in accordance with this protocol.
The results of the study can be presented in scientific meetings or published in scientific journals. In these cases, the privacy of the participants is strictly protected. In addition, in each trial, volunteers are insured against any undesirable situation that may occur as long as they take the drug. Safety is a top priority in clinical trials.
10 - Is it possible to leave the clinical trial at any time? Is there a risk of damage in this case?
The volunteer has the right to leave the clinical trial at any time. Separation of the volunteer from the study other than for medical reasons may cause disruption of the clinical trial. No compensation or corporate sanction can be applied to the volunteer due to this decision.
11 - Who is called a volunteer?
Clinical research is carried out in accordance with international standards, guidelines, declarations and local legislation in the world and in our country. Patients or healthy persons who participate in the clinical trial by obtaining written consent in accordance with the relevant legislation.
In this context and in accordance with the rules of this kind of people who participated in such research volunteer or participant, never and never in any country "guinea pig" or "subject" adjective and should not be approached.
12 - What rights do volunteers have in a clinical trial?
To know that the study is a clinical research,
To be aware of the known risks,
To be aware of the known benefits,
To know alternative treatments or practices,
Knowing that privacy is protected,
Knowing whom to consult for further information,
To know that participation is voluntary and can be withdrawn from the research at any time,
Knowing that treatment and follow-up will be performed if necessary,
To know that even the smallest damage that may occur due to the research will be covered.
13 - What are the benefits of participating in a clinical trial?
Although there are differences in the specificity of each study, the following benefits can be listed:
Obtaining the highest level of medical care, laboratory facilities free of charge and using the drugs to be applied free of charge by the doctors who know the disease status,
Benefit from a new treatment before it is released,
To contribute to the development of medicine and drug science on behalf of humanity,
In some types of study, there is no option that the medicines used may benefit their illnesses because the participants are healthy.