On the territory of “Certa Clinic”, clinical studies of drugs involving humans are carried out. Not all patients, but those eligible for inclusion and exclusion criteria are invited for participation in a clinical study.
Main criteria for study inclusion are the presence of a certain diagnosis and a patient’s willingness to participate in a study.
Other selection criteria are used not to enroll people to the study for which study participation and drug administration can appear not safe.
- Unexpected and previously unknown adverse reactions can occur;
- New treatment can be inferior to common treatment or ineffective;
- A new treatment method may not be obtained in a randomized clinical study – if a new method is compared with a “conventional” treatment method or “placebo” (simulation of a drug not containing a drug substance).
In studies comparing two treatment methods, about one half of patients takes a new drug, and the second half takes either a conventional treatment or placebo. Neither a patient nor attending physician can select which of the treatment methods a patient included to the study will get. And a patient does not know which of the treatment methods he/she gets. Participation in a clinical study does not prejudice patient’s rights. Any patient can withdraw from study program on any stage, in any moment not explaining his/her reasons.