Information for patients
A clinical trial is any research conducted with participation of individuals for the purpose of discovering or confirming the efficacy of medicinal products. (definition as per Art. 2 Item 2 of the Pharmaceutical Law, Journal of Laws of 2017, Item 2211).
Phases of Clinical Trials
Phase 1: Is it safe?
Phase 1 includes research conducted with a small group of healthy volunteers (20–80), usually aimed at:
- making a basic evaluation of the safety using investigational medicinal product,
- determining the dosage level of the medicinal product,
- obtaining data on gastrointestinal absorption of the medicinal product tested, on its level in blood and tissues, excretion, toxicity, interactions with other medications and with food.
Length of Phase 1: Several months.
Phase 2: Does it work?
Phase 2 includes research conducted on a specific number of people with the disease or condition (100–300). Phase 2 is aimed at:
- assessing and specifying the dosage,
- determining the efficacy of the investigational medicinal product,
- assessing the safety of use.
This kind of research is usually randomised, which means that one group of patients will be administered the test product, while the other as a control group is given a standard treatment.
Length of Phase 2: Several months to several years
Phase 3: Is it better compared to the products available on the market?
Phase 3 usually involves multicentre trials in which the size of the research group is from several hundred up to several thousand patients. The primary purpose of phase 3 is:
- comparing the new product to the commonly used therapeutic standards,
- confirming the efficacy of the investigational medicinal product,
- monitoring adverse reactions.
Due to the fact that phase 3 is the most extensive one, the research is frequently conducted in the form of blind tests to eliminate bias or the placebo effect. Phase 3 trials provide the most information as they are conducted on a large number of people and may last for several years.
Phase 4: What are the long-term effects?
Phase 4 of the research is conducted after the medicinal product has been authorised for marketing. The purpose of phase 4 is:
- monitoring the efficacy of the medicinal product and the safety of long-term use of the product,
- analysing the efficacy of the medicinal product in comparison with alternative products used in standard treatment,
- determining the costs of introducing the new medicinal product to standard treatment.
This phase is concerned with various groups of people and an even larger number of volunteers. The results of phase 4 trials may be used to modify the known treatments and even to set new standards of treatment.
Bioequivalence studies are a special type of research where the effects of the investigational medicinal (generic) product are compared with the effects of a reference product already available on the market. Bioequivalence analyses are designed to confirm the new product’s equivalence and safety of use.
New generic medicines contain the same active ingredient and show the same pharmacological effect as the original medicines.
During the administration of the generic drug as well as of the original drug, the subjects are monitored in the Centre for approx. 2 to 3 days. For each stay, we ensure full board and 24/7 specialist care.
Between the administration of the generic drug and the original drug, it is necessary to ensure time for washout of the active ingredient, it usually takes from 1 to 3 weeks. The order in which the drugs are administered is random.
The detailed schedule of visits and stays in the Centre are determined separately for each study.
The subjects of bioequivalence studies usually include healthy non-smoking volunteers between 18 and 55 not currently under long-term course of medications.
Prior to the decision on taking part in the study, the volunteers are invited to attend information meetings when the study plan, subject profile and medication type are described. The volunteers are ensured sufficient Q&A time and time for making an informed decision about participation.
Bioequivalence study stages
The benefits of participating in clinical trials
Watch the videos below to find out more about the process of clinical trials:
A clinical trial means any research conducted with participation of individuals for the purpose of discovering or confirming the efficacy of medicinal products (definition as per Art. 2 Item 2 of the Pharmaceutical Law, Journal of Laws of 2017, Item 2211).
- assessing the safety and efficacy of medicinal products
- comparing new treatment methods with the standard therapies
- investigating new indications, form or dosage
- evaluating the quality of life of patients
The subjects of clinical trials may be healthy individuals (bioequivalence studies) or individuals with particular conditions (phase 2 and 3 trials). The subjects are recruited based on their medical history, examinations and tests as well as qualification criteria specified for each trial.
- For trials conducted on healthy volunteers, prior to the commencement of trial, each potential subject will undergo a series of tests to assess the condition of his or her organism so as to exclude the possible negative effects of the studied medicinal product.
- During the qualification of subjects with diagnosed conditions, the scope of examinations and tests is determined in accordance with the qualification criteria indicated in the trial protocol.
- Prior to commencing participation in a clinical trial, the volunteer receives information on the potential risks that may arise from participating in the trial.
- Our highly qualified and experienced specialists spare no effort to ensure safety of the subjects during their stay in the Centre.
- The Clinical Trials Centre operates according to procedures adopted to ensure safety of the subjects as well as quick reaction in case of any adverse events.
- The clinical trials are conducted in accordance with Good Clinical Practice and the procedures adopted in the Centre.
- Prior to commencement, each clinical trial must be approved by the Minister of Health and an institutional review board. These institutions are to determine whether the trial is organised with due safety precautions.
- In case of injury during the study each subject may claim damages.
- Before deciding to participate in a trial, you should obtain as much information on the trial as possible – for this purpose, information meetings are organised, where the Principal Investigator will answer all your questions. During the meeting, subjects should carefully read the Subject/Patient Information.
- Attending the information meeting is not equal participation in a trial. Before you decide to take part in a trial, consider the benefits and risks, and determine your availability.
- Each of the subjects of a clinical trial may withdraw from it at any time without stating a reason. The subject will not face any consequences of withdrawal.
- The Clinical Trial Centre is located in the building of Vratislavia Medica St. John Paul II Hospital in Wroclaw, 1Lekarska Street. During the bioequivalence studies, the subjects stay in a special ward on the 3rd floor, in spacious double rooms with bathrooms.
- So as to ensure maximum comfort, we provided a TV set in each room and a free Wi-Fi network.