No special preparation is required for the first interview. Make sure you bring your complete medical documentation. The study doctor will answer all your questions during the first interview, so it is a good idea to write down everything that is not clear. If necessary, the patient can bring a trusted person with him/her for support.
Yes, the patient may choose to leave the study at any time. It is only necessary to inform the leading study physician, who will record the reason for the patient’s withdrawal from the study.
Each study is based on a protocol which covers the clinical study plan in detail. The protocol is carefully designed to ensure the safety of participants (patients) and the relevance of the final results. The protocol defines, among other things, what characteristics a patient must have in order to be included in a particular clinical study, the schedule of diagnostic tests, procedures related to the administration of study drug(s) and drug doses, and the duration of the study. In accordance to the protocol, patients regularly undergo clinical examinations by a competent physician to monitor their health status and determine the safety and efficacy of the study drug used.
Many studies are conducted in such a way that one group of patients receives a new experimental drug or other inovative treatment, while the other group receives the standard treatment or placebo. The latter group is referred to as the control group and is used to compare the results of the study drug with the current standard.
Clinical trials are conducted in phases. The preclinical phase of testing is the initial stage when in vitro (in laboratory) studies and in vivo (on animals) studies are performed. This is followed by the clinical phase of the trial, which can be divided into four segments:
Phase 1. Researchers are testing a new drug on a small group of healthy individuals (20-80) to analyze the safety of drug administration for the first time, in order to determine the safe dose of the drug and identify possible side effects.
Phase 2. The study drug is administered to a slightly larger group of patients (100-300) to analyze the efficacy of the drug and to continue monitoring of side effects.
Phase 3. The study drug is administered to a large group of patients (1000-3000) to confirm efficacy, monitor side effects, compare the effect of the new drug versus standard therapy, and to gather data that allows the drug to be safely administered.
Phase 4. These are so called post-marketing studies, which gather additional information of the risks and benefits of the drug and determine the optimal use of the drug.
