What is a clinical study?
Clinical studies are one of the last steps in the long process of drug development and approval, prior to placing the drug on the market. The only way to develop safe and more effective drugs is to use the information obtained from clinical studies. Drug testing is a process lasting several years, during which any negative impacts on human health are ruled out and benefits of the new drug or medicinal product are confirmed. If the drug efficacy and safety is not sufficiently proven, the study is terminated.
What is the purpose of clinical studies?
In clinical stages, drugs administered to people are investigated. In the course of the drug testing, it is determined whether the substance is effective, as well as whether it has any adverse effects. The substance behaviour in the body, its absorption, excretion or change to other substances is assessed.
The patient is the most important element of the clinical trial. There is no other way of simulating the behaviour of the investigated substance in the human body. Therefore, the participation and involvement of people in the process is essential – the result will not only help the individual, but can help many others suffering from the same illness.
Participation in a study – the drug approval process – is always voluntary and free.
What are the advantages of participation in a study?
By participating in a study, you get access to drugs that should potentially be more effective than standard available medicines, or that with the same level of efficacy, there will be a lower risk of adverse effects. Standard treatment is usually regarded as an alternative.
In the studies, the protocol usually requires more careful patient monitoring compared to common appointments with the attending physicians. This improves safety for the clinical study participants.
There is no need to worry about participating in a study, but you should always carefully consider whether the study conditions suit you. Don’t be afraid to ask, if you have any doubts or reservations.
What is the clinical study process?
I – This phase is not available with us
The drug is administered to people, usually healthy volunteers, for the first time. It is established whether the human body tolerates the substance and what its “journey” through the body is. At the same time, potential adverse effects are monitored. Research on healthy volunteers is not performed, if the substance administration to a healthy individual is unsuitable or would be dangerous (e.g. cytotoxic agents).
II – This phase is available with us
In phase II of the clinical trial, the drug is first administered to a small number of exactly defined ill patients, based on very strict criteria. Therapeutic effects are proved, suitable dosage is defined, and further drug information is collected. If the efficacy exceeding the risk of adverse effects is confirmed in this phase, it is possible to proceed with phase III, where hundreds to thousands of patients get involved in order to verify the drug efficacy. At the same time, additional safety information can be obtained.
III – This phase is available with us
In this phase of drug development, a large group of volunteers get involved and the treatment efficacy of the new drug is compared to the standard and currently available treatment. The efficacy and safety of the candidate drug is investigated, dosage is specified, etc. Only based on the results, the drug can be registered. In the Czech Republic, studies performed at this phase are the most common. They are organized internationally, there are several participating countries and centers.
IV – This phase is available with us
In this phase, the occurrence of adverse effects is carefully monitored, as well as the drug effects in long-term use and information about possible interactions with other drugs. Drugs have been approved and are available in the pharmacy.
Recruiting studies:
The recruitment for a clinical trial treating patients with active moderate to severe Ulcerative Colitis is in progress in the following cities:
- Strakonice
- Klatovy
- Olomouc
The recruitment for a clinical trial treating patients with active moderate to severe Crohn Disease is in progress in the following cities:
- Strakonice
- Klatovy
- Olomouc
The recruitment for a clinical trial treating women suffering from moderate to severe Vasomotor Symptoms (Hot Flashes) is in progress in the following cities:
- Cheb
- Plzeň
- Náchod
- Hradec Králové
- České Budějovice
The recruitment for a clinical trial treating patients with Cancer of unknown primary site is in progress in the following cities:
- Praha
The recruitment for a clinical trial assessing contraceptive efficacy, tolerability and safety of hormonal contraception is in progress in the following cities:
- Třeboň
- České Budějovice
- Vodňany
- Vysoké Mýto
The recruitment for a clinical trial treating patients with previously Untreated Unresectable or Metastatic Melanoma is in progress in the following cities:
- Praha
The recruitment of women for a clinical trial to verify the concept of treatment of patients with overactive bladder during the 12-week treatment period is in progress in the following cities:
- Plzeň
The recruitment of patients for a phase III clinical trial comparing the efficacy and safety of 2 drugs for the treatment of age-related neovascular macular degeneration is in progress in the following cities:
- Sokolov
- Praha
The recruitment of patients for a phase III clinical trial evaluating the efficacy of meningococcal vaccines given to adolescents and young adults is in progress in the following cities:
- České Budějovice
- Příbram
The recruitment of patients for a phase III clinical trial comparing the efficacy and safety of a medicine for moderate to severe acne is in progress in the following cities:
- Praha
The recruitment of patients for a phase III clinical trial comparing the efficacy and safety of a medicine for the treatment of moderate to severe Hidradenitis suppurativa, also known as acne inversa, is in progress in the following cities:
- Praha
The recruitment for a clinical trial treating women suffering from moderate to severe Vasomotor Symptoms (Hot Flashes) is in progress in the following cities:
- Dubnica nad Váhom
The recruitment for a clinical trial treating women with recurrent vulvovaginal candidiasis is in progress in the following cities:
- Bánovce nad Bebravou
- Nové Mesto nad Váhom
- Dubnica nad Váhom
- Púchov
If you wish to receive further information about a clinical trial, please do not hesitate to contact us.
See also:
What is a clinical study?
Clinical studies are one of the last steps in the long process of drug development and approval, prior to placing the drug on the market. The only way to develop safe and more effective drugs is to use the information obtained from clinical studies. Drug testing is a process lasting several years, during which any negative impacts on human health are ruled out and benefits of the new drug or medicinal product are confirmed. If the drug efficacy and safety is not sufficiently proven, the study is terminated.
What is the purpose of clinical studies?
In clinical stages, drugs administered to people are investigated. In the course of the drug testing, it is determined whether the substance is effective, as well as whether it has any adverse effects. The substance behaviour in the body, its absorption, excretion or change to other substances is assessed.
The patient is the most important element of the clinical trial. There is no other way of simulating the behaviour of the investigated substance in the human body. Therefore, the participation and involvement of people in the process is essential – the result will not only help the individual, but can help many others suffering from the same illness.
Participation in a study – the drug approval process – is always voluntary and free.
What are the advantages of participation in a study?
By participating in a study, you get access to drugs that should potentially be more effective than standard available medicines, or that with the same level of efficacy, there will be a lower risk of adverse effects. Standard treatment is usually regarded as an alternative.
In the studies, the protocol usually requires more careful patient monitoring compared to common appointments with the attending physicians. This improves safety for the clinical study participants.
There is no need to worry about participating in a study, but you should always carefully consider whether the study conditions suit you. Don’t be afraid to ask, if you have any doubts or reservations.
What is the clinical study process?
I – This phase is not available with us
The drug is administered to people, usually healthy volunteers, for the first time. It is established whether the human body tolerates the substance and what its “journey” through the body is. At the same time, potential adverse effects are monitored. Research on healthy volunteers is not performed, if the substance administration to a healthy individual is unsuitable or would be dangerous (e.g. cytotoxic agents).
II – This phase is available with us
In phase II of the clinical trial, the drug is first administered to a small number of exactly defined ill patients, based on very strict criteria. Therapeutic effects are proved, suitable dosage is defined, and further drug information is collected. If the efficacy exceeding the risk of adverse effects is confirmed in this phase, it is possible to proceed with phase III, where hundreds to thousands of patients get involved in order to verify the drug efficacy. At the same time, additional safety information can be obtained.
III – This phase is available with us
In this phase of drug development, a large group of volunteers get involved and the treatment efficacy of the new drug is compared to the standard and currently available treatment. The efficacy and safety of the candidate drug is investigated, dosage is specified, etc. Only based on the results, the drug can be registered. In the Czech Republic, studies performed at this phase are the most common. They are organized internationally, there are several participating countries and centers.
IV – This phase is available with us
In this phase, the occurrence of adverse effects is carefully monitored, as well as the drug effects in long-term use and information about possible interactions with other drugs. Drugs have been approved and are available in the pharmacy.
Recruiting studies:
The recruitment for a clinical trial treating patients with active moderate to severe Ulcerative Colitis is in progress in the following cities:
- Strakonice
- Klatovy
- Olomouc
The recruitment for a clinical trial treating patients with active moderate to severe Crohn Disease is in progress in the following cities:
- Strakonice
- Klatovy
- Olomouc
The recruitment for a clinical trial treating women suffering from moderate to severe Vasomotor Symptoms (Hot Flashes) is in progress in the following cities:
- Cheb
- Plzeň
- Náchod
- Hradec Králové
- České Budějovice
The recruitment for a clinical trial treating patients with Cancer of unknown primary site is in progress in the following cities:
- Praha
The recruitment for a clinical trial assessing contraceptive efficacy, tolerability and safety of hormonal contraception is in progress in the following cities:
- Třeboň
- České Budějovice
- Vodňany
- Vysoké Mýto
The recruitment for a clinical trial treating patients with previously Untreated Unresectable or Metastatic Melanoma is in progress in the following cities:
- Praha
The recruitment of women for a clinical trial to verify the concept of treatment of patients with overactive bladder during the 12-week treatment period is in progress in the following cities:
- Plzeň
The recruitment of patients for a phase III clinical trial comparing the efficacy and safety of 2 drugs for the treatment of age-related neovascular macular degeneration is in progress in the following cities:
- Sokolov
- Praha
The recruitment of patients for a phase III clinical trial evaluating the efficacy of meningococcal vaccines given to adolescents and young adults is in progress in the following cities:
- České Budějovice
- Příbram
The recruitment of patients for a phase III clinical trial comparing the efficacy and safety of a medicine for moderate to severe acne is in progress in the following cities:
- Praha
The recruitment of patients for a phase III clinical trial comparing the efficacy and safety of a medicine for the treatment of moderate to severe Hidradenitis suppurativa, also known as acne inversa, is in progress in the following cities:
- Praha
The recruitment for a clinical trial treating women suffering from moderate to severe Vasomotor Symptoms (Hot Flashes) is in progress in the following cities:
- Dubnica nad Váhom
The recruitment for a clinical trial treating women with recurrent vulvovaginal candidiasis is in progress in the following cities:
- Bánovce nad Bebravou
- Nové Mesto nad Váhom
- Dubnica nad Váhom
- Púchov
If you wish to receive further information about a clinical trial, please do not hesitate to contact us.
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