What is a clinical trial?
Clinical Trial is every trial conducted with participation of people, in order to:
- discover or confirm clinical, pharmacological, including pharmacodynamic effects of action of one or many tested therapeutic products
- identify undesired effects of one or a larger number of examined therapeutic products
- investigate absorption, distribution, metabolism and elimination of one or a larger number of examined therapeutic products, having in mind their safety and effectiveness; (definition under art.2 item 2 of the Pharmacy Act, Journal of Laws, Dz.U.2017 item 2211).
Clinical trials are aimed at finding new methods of treatment as well as of new drugs to combat known diseases. Every drug, wound dressing or medical procedure which is released to be used on a medical market, undergoes three phases of clinical trials.
Phases of Clinical Trial:
- In Phase 1 a trial is conducted on a small number of healthy persons or sick patients in case of a drug for incurable disease. In the trial of Phase 1 the safety is verified, along with effectiveness of a drug being tested, as well as its impact on an organism. Such a trial is conducted mainly in laboratories.
- In phase 2 a clinical trial is conducted on a larger number of patients suffering from a given disease, on whom effectiveness of an examined drug for a specific disease is checked, along with the safety of a drug being tested. Also, an effective dose of the examined drug is specified by a comparison with the so-called placebo, administered as part of a trial to a group of patients. Trials of phase 2 are conducted in centers specializing in given diseases.
- Clinical trial of Phase 3 is conducted on a very large number of patients. Main objectives of a trial of this phase include: first and foremost, evaluation of safety and effectiveness of a given drug, specification of appropriate dosage to be used in therapy, evaluation of undesired incidents, i.e. counterindications to use of this drug in patients with a given disease or comparison of clinical trials results with standard methods of treatment.
Trials of phase 3 last even for several years. After a completion of a trial and obtaining of a good result one can apply for registration of a new drug for a given disease.
- Clinical trial of Phase 4 constitutes the so-called trial following the registration and release of a given drug to the market. Such a trial lasts for a relatively long time and is conducted on a large number of patients in order to confirm effectiveness, safety as well as undesired incidents, for example, effects after many years of using a given substance or undesired interaction with other substances used by a patient.
Is participation in clinical trial safe for a patient?
Participation in a clinical trial is completely safe. Each clinical trial in Poland is required to have a consent of the bioethical committee and the President of the Agency for Registration of Medicinal Products, Medical Devices and Biocidal Products.
Patients’ s safety and the patient’s rights have been outlined in Good Clinical Practice guidelines. A clinical trial is conducted pursuant to the Polish as well as international legal norms. Prior to the commencement of a clinical test a patient signs an Informed Consent Form (ICF), in which a course of the trial, a method of dosage of a drug and undesired effects are described in detail. During a trial a patient will remain under the continuous care of an experienced and qualified research team.
What are the rights of the patient participating in a clinical trial?
All rights and obligations of a patient are described in a trial protocol. Patient, making a decision to participate in a treatment being a part of a clinical trial, will sign an Informed Consent Form (ICF) and therefore declares to conform to a trial protocol, i.e. to come for appointments in a center, dose a drug according to a researcher’s guidelines. Patient’s personal data during a trial and after its completion are confidential. Patient’s participation is voluntary and at every moment a patient can resign for any reason, without any consequences.
Who can participate in a clinical trial?
Every patient suffering from a disease related to a specific trial or a healthy volunteer can participate in a clinical trial. Patient who decides to participate in the treatment must, first and foremost, sign an Informed Consent Form (ICF), meet criteria of inclusion and exclusion contained in a trial protocol, which are evaluated by the Principal Investigator -PI (a physician in charge of a clinical trial).
The following categories of patients will be disqualified from participation in a clinical trial: patients using drugs, the effect of which on the tested drug is undefined or unfavorable, as well as patients suffering from co-existing diseases, where the impact of a tested drug on this disease will be unfavorable – all counterindications of participation in a given clinical trial are described in criteria of exclusion and will be evaluated by the Principal Investigator.
What are the costs incurred by a patient participating in a clinical trial?
All costs related to a trial will be paid by a trial sponsor (a pharmaceutical company). If a patient incurred any costs, for example travel costs, they will be reimbursed after a completion of a trial Patient participating in a clinical test remains under the free-of-charge of the best specialists.
Is it worth participating in a clinical trial?
Obviously, yes. Owing to a participation in a clinical trial a patient will receive:
- free-of- charge examinations, diagnostics and treatment with the latest generations of drugs;
- free-of-charge care of the best specialists in a private medical center;
- admittance to the latest methods of treatment and innovative products, which are unavailable or barely available on a medical market.