CLINICAL TRIALS DICTIONARY
Here you will find basic concepts related to clinical trials and other basic concepts in the field of healthcare.
Adverse drug reaction
An adverse and unintended response to a medicinal product that occurs after a dose commonly used for the prophylaxis, treatment, diagnosis, or restoration, adjustment, or other effect of physiological functions.
Information obtained by interviewing the patient or his relatives.
Family history: Information on family diseases can help doctors make the right diagnosis. If a disease occurs more often in the family or at a younger age than usual, it is necessary to think about such a disease in the patient.
Personal history: Information on previous diseases.
Social and work history: Information on the patient's social and work situation.
Pharmacological history: Information on past and current drugs.
Habits: Information on whether the patient smokes, consumes alcohol or other drugs.
Biosimilars are biological medicinal products similar to original products. They can be registered and used in practice only after the expiration of their patent protection. Like all biological products that are the product of living organisms, they are naturally variable. Unlike conventional, so-called generic products (see G.), preclinical and clinical studies comparing biosimilars with the original product are required in the registration procedure to assess the efficacy and safety of biosimilars.
Positive effect of treatment.
Also a clinical trial serves to verify the safety and efficacy of new treatments, most commonly drugs or drug combinations. Each medicine used in practice had to undergo clinical trials.
Clinical study protocol
Each study is performed according to precisely given instructions - protocol. The protocol specifies the objectives of the study, its duration, required examinations, method of treatment, method of solving some predictable situations (for example postponement of the next treatment cycle or dose reduction in case of side effects), as well as dates of ongoing evaluations, method of statistical processing, etc.
Body evaluating the ethical side of the clinical study - eg that unjustified examinations are not performed, that the patient is not at disproportionate risk, that appropriate treatment is used in the comparison group, etc. The composition and activities of ethics committees are determined by law they have no relation to the medical facility. The Ethics Committee also receives ongoing information on the safety of the study drug - in the event that the risks to patients increase disproportionately, it may order the study to be terminated. He therefore oversees the clinical trial throughout its duration.
It is a food intended to supplement a normal diet and which is a concentrated source of vitamins and minerals or other substances with a nutritional or physiological effect, contained in the food alone or in combination. Dietary supplements do not prove to be effective, but only harmless.
Proces, který zahrnuje sledování užívání léčivých přípravků v každodenní klinické praxi tak, aby bylo možné odhalit dříve nerozpoznané nežádoucí účinky nebo změnu charakteru nežádoucích účinků.
Generický léčivý přípravek (generikum)
Legal copy of the original medicinal product. After the expiry of the withdrawal period, during which only the original drug could be on the market, generic products containing the same active substance in the same pharmaceutical form (eg tablets or injections) come very quickly. Generics may contain other excipients. The launch of a generic drug is not preceded by any complex research.
Good Clinical Practice
A standard for planning, conducting, conducting, monitoring, and other activities that ensure reliable and accurate data, protect the rights and integrity of those enrolled in a clinical trial, and keep their data confidential. The principles of good clinical practice must be followed by each workplace where the clinical trial takes place and all staff involved in conducting the clinical trial.
Recommended procedures - are understood as non-binding, highly professional recommendations for the diagnosis and treatment of the disease.
Informed patient consent
It is consent to be included in a clinical study by which the patient declares that he has received written information and that he has had the opportunity to ask the doctor about the study, that he agrees with some of the tests performed and that he enters the study voluntarily. The patient can revoke his consent at any time, but it is advisable to think carefully before signing the consent, or consulted with family, etc., and if he has any ambiguities or reservations not to agree to inclusion in the study. The form describes the entire course of treatment, individual examinations, lists all risks and expected side effects.
The simplest medical devices - glasses, bandages, stethoscope, wheelchair, syringes without needles, crutches, etc., as well as needles, surgical gloves, contact lenses, orthoses and prostheses, hearing aids and other electromechanical devices - SONO, ECG, etc. up to technologically very advanced and complex, which must meet strict requirements (artificial joints, imaging devices). It also includes in vitro diagnostic medical devices (IVD) - eg laboratory diagnostic devices (biochemical analyzer), diagnostic tests (pregnancy test, tests of various diseases) and active implantable medical devices - eg pacemakers, cochlear implants.
The Medicinal Products Act defines a medicinal product as a substance or combination of substances with therapeutic or preventive properties that can be used either to restore, modify or influence physiological functions through a pharmacological, immunological or metabolic effect, or to make a medical diagnosis. It does not matter whether we use the term medicinal product, drug or medicine. All statements mean the same thing.
Original medicinal product
An original medicinal product ('reference medicinal product') is the first authorized medicinal product with a new active substance that has not been contained in any other medicinal product. The active substance and possibly also the production process (know-how) is protected by a patent. An original medicinal product that successfully passes the marketing authorization will then have a withdrawal period during which no one will be able to place copies (generics) of such a product on the market.
OTC as "over the counter" - a drug that can be dispensed without a prescription or over-the-counter drug.
A process that involves monitoring the use of medicines in everyday clinical practice so that previously unrecognized side effects or a change in the nature of the side effects can be detected.
An inactive substance that is administered in the same form as the active substance. It is used in conducting clinical trials.
Price of the drug
The determination of the price and reimbursement of a medicinal product from health insurance is carried out within the Czech Republic by the State Institute for the Control of Medicinal Products in a demanding process of so-called administrative proceedings.
Random division of subjects into groups, ie either the group receiving the test drug or the control group. The control group can be given either placebo (an inactive substance that is formulated in the same way as the medicine) or the medicine with which the test medicine is compared (eg in cases where placebo instead of the active medicine could harm the patient). The purpose of randomization is to reduce bias and increase the validity of the obtained data. Double blinding is also used to obtain objective results, a procedure in which neither the examining physician nor the subject of the evaluation knows which group he was included in.
Rx (also "Rp")
Medicinal product subject to medical prescription or prescription.
Closer connection of laboratory research with clinical practice.