The primary objective of phase I clinical studies is to demonstrate the safety of using drugs in healthy human volunteers, the secondary objective is to assess the effects of the study drug on the condition and overall body functions, based on physical examination, complaints, instrumental and laboratory methods of examination. Clinical studies of that phase are not aimed at assessing effectiveness of the medicinal drug, therefore the studies are conducted on healthy volunteers, not on patients with the target indications.
Bioequivalence study is a comparative study of two drugs manufactured by different companies, with the same active ingredient. The objective of such studies is to compare pharmacokinetics (absorption, distribution and excretion) of two drugs and to assess their relative safety.
All studies which are being conducted should be approved by the Ministry of Healthcare of the Russian Federation and by Independent Ethics Committee, are conducted in an inpatient setting under strict monitoring by healthcare personnel, company monitors, auditors of independent and state-owned institutions. Basic principles of study conduct, including safety and confidentiality of data are met.
All potential risks related to the study are detailed in the Volunteers’s information leaflet which is an integral part of the clinical study or bioequivalence study documents. A volunteer may take part in a study only after signing this document.
The study sponsor ensures insurance of all volunteers according to the current legislation, and payment for participation in clinical studies.
A study participant on completion of the study receives a compensation for participation in the study. The volume of payment may vary depending on complexity, duration of the study and is discussed before each specific study.
Food, medical examinations, stay at the study site are free for all volunteers.
Who is entitled to become a clinical study participant (volunteer)?
If you are older than 18 years old, you are overall healthy, you may potentially participate in a clinical trial as a volunteer.
You cannot participate in a clinical trial if:
Frequently asked questions of volunteers before taking a decision to participate in the study:
How long does the study last?
It depends on a specific study. Hospitalization may last on the average 2 to 4 days, which means that you will need 2 to 4 days off that you will have to spend in a clinic. In some cases additional outpatient (without the need to stay at hospital) visits may be required. The duration of the study depends on the drug, the dosing regimen, blood collection and test frequency and other factors.
Do I have to have the illness the test drug is targeted at?
No. The study of medicinal drugs in healthy volunteers does not involve the study of efficacy of the drug, only its safety is assessed.
May volunteers take part in several studies?
Yes, of course. Many healthy volunteers take part in several studies. The only condition that should be met, one cannot take part in several studies simultaneously. Besides, there must be a break between the studies, so called “washout period” of 3 months.
What would be the risks for me and my health if I take part in the study?
Any clinical study undergoes thorough preparation and review. All clinical studies are conducted according to god practice, each study must be approved by the Ministry of Healthcare of the Russian Federation and International Ethics Committee, is conducted at inpatient or outpatient setting under strict control of healthcare personnel, company monitors, auditors, independent and state-owned institutions. Health risks in phase 1 studies and bioequivalence studies are minimal, however, considering the investigational nature of the medicinal drugs studied at phase one clinical studies, side effects are possible. They are not suspected or expected for each medicinal drug. Full information on effects of the drug and on its potential adverse reactions is described in the Volunteer information leaflet. By reading it carefully before the study you may take your own decision to participate in the study or not. Before the study begins, your study doctor will explain to you the study objective, indications of the drug and other important information in simple understandable lay terms. This information is also important to assess the risks and take an informed decision on participation.
May I discontinue from the study if something happens to me (illness, injury) during the study or if I am no longer willing to take part in the study, or if I change my mind?
You may discontinue from the study at any time.
Will I have to comply with some terms, conditions during hospitalization?
Yes. The requirements vary with specific study, detailed description of conditions to be complied with during the study, while in clinic or in an outpatient setting, will be specified in the Volunteer information leaflet.
May I expect to receive emergency medical aid?
Yes. The safety of volunteers is the priority at phase 1 studies of drug bioequivalence.
What are the benefits I am entitled to if I decide to become a volunteer?
After completion of the study you will receive a compensation. You will be informed of the sum of compensation before inclusion into the study. You will undergo instrumental and laboratory studies (normally including physical examination, complete blood cell count, urine test, blood biochemical test, ECG), which will provide a true picture of your current health condition.