Information for patients
Clinical studies
Clinical trials are research projects in which patients can voluntarily participate. They are part of the many-year process of developing a new medicinal product, at the end of which the drug may be registered and used in routine practice.
The journey of each drug begins in laboratories, animal tests continue, and after long research, medicinal products that have been proven to be sufficiently safe and effective begin to be tested in clinical trials involving patients or healthy volunteers. All clinical studies are approved by the State Institute for Drug Control and relevant ethics committees.
What precedes clinical trials
In order for a drug to enter clinical evaluation, it must undergo thorough testing in laboratory conditions. In reality, out of every 50,000 new molecules developed in laboratories, only 5 potential drugs reach the clinical trial phase. Of these, only 1 survives and reaches the patients. Others do not demonstrate sufficient efficacy, suitability or safety, etc. during extensive clinical evaluation. In these cases, the research is terminated.
Who can participate in clinical trials
The subject of the evaluation can be either a healthy volunteer or a patient. A volunteer or patient can only be included in the study after meeting all the criteria given by the protocol, regarding his illness and general health, and after passing the prescribed entrance examinations. He confirms his agreement to participate in the clinical study by signing the so-called informed consent, but the patient can change his opinion at any time and end the participation without further consequences. Participation in the study is free.
How security is guaranteed
All information about the conducted study is checked and analyzed in detail. If the drug does not demonstrate sufficient efficacy and safety, the study is terminated.
The tools to ensure security are:
- compliance with the study protocol
- securing the signature of the Informed Consent and patient instruction
- control by ethics commissions
- control of the State Institute for Drug Control, or other state administration bodies
- mandatory insurance of clinical trial participants
- compliance with the principles of Good Clinical Practice
The clinical study at a specific workplace is also monitored by so-called monitors, who are sent by the study sponsor for regular control visits, so that each clinical study takes place exactly according to the given rules. All safety information can also be found in the Informed Consent.
Benefits and risks in the study
Possible benefits:
- access to a new treatment before it is generally available
- helping future or other patients by participating in research on new treatments
Possible risks:
- not all side effects of the researched treatment are known yet, they may be less or more serious compared to standard treatment
- this is a clinical research project and it may turn out that the treatment is not better or even as good as the standard treatment
Availability of information regarding ongoing studies
Clinical studies are taking place all over the world, including many Czech workplaces. The database of all ongoing clinical trials is offered by the State Institute for Drug Control, you can also find the workplace where the given clinical trials are taking place. You can, of course, ask a targeted question about the possibility of inclusion in a clinical trial directly to your attending physician.
Where to find more information:
http://www.linkos.cz/slovnicek/klinicka-studie/
http://www.cancer.gov/clinicaltrials (English)
http://www.clinicaltrials.com/
https://www.clinicaltrialsregister.eu/ (English)
https://www.mou.cz/klinicke-studie
Source of information