Clinical trials of new drugs, conducted in cooperation with medical professionals around the world, are an indispensable part of clinical research. They aim to find out whether an experimental treatment is safe and effective for patients with a particular disease. People who take part in clinical trials are always volunteers. Clinical trials are broken down into several phases. It may take several years to ensure the new treatment has been properly tested before it is made available to a broader population of patients.
Clinical trials help:
Develop potential new medicines
Discover if certain medicines work better than others
Find new users for already-approved medications
The Phases of a Clinical Trial
Phase I primarily evaluates the safety of an experimental drug that is administered to a human for the first time. This experimental drug is administered to a small group of healthy volunteers (20-80 people).
Phase II is focused on evaluating the efficacy of the experimental drug. It involves a group of 100-300 patients, and is conducted in several centers globally.
Phase III is the most important phase of a clinical trial. Typically, it is a comparative clinical trial and involves a group of 1,000–3,000 people. The aim is to demonstrate that the experimental drug is more effective than the standard available treatment.
Phase IV is performed once a drug has reached the market, to provide additional information about the efficacy of the drug as well as its risks.
Some medical centers in the Czech Republic are involved in various phases of over 70 international clinical trials conducted by Novartis. All ongoing trials are supervised by the State Institute for Drug Control (SÚKL), as well as the medical centers’ respective ethical commissions.
Click here for a list of clinical trials currently underway in the Czech Republic.
Therapeutic areas in which clinical trials are being performed: