Clinical trials – informations

Drugs and medical devices must be assessed as safe and effective before entry into the market.

For this purpose rigorous clinical trials are conducted to observe and control the product action on the included patients. Studies are conducted in several phases and in accordance with Good Clinical Practice principles.

4 Clinical trial phases

The individual phases of clinical trials vary in terms of their objectives and nature as well as persons who take part in these studies.

The first phase involves testing a drug on a small group of healthy patients in order to determine whether the product is safe for the human body, diagnose side effects and provide dosage recommendations.

The second phase is conducted on a larger group of persons suffering from the conditions for which medical device was developed. The short- term efficacy and safety is observed and the optimal dosage is determined.

The third phase involves a group of thousands of persons, the purpose of this phase is to ensure the efficacy and safety over a long period of time. This phase also compares the action of a new product with standard drugs and placebo to see if the drug works more effectively.

The final, fourth phase takes place after the product has received marketing authorisation and involves collecting results from the patients who have been prescribed the product by their doctors.

Principles for conducting a clinical trial.

All clinical trial activities must be conducted in accordance with Good Clinical Practice (GCP) guidelines. According to these, patient’s safety, welfare and rights take precedence over the interests of science. Clinical trials must therefore be conducted in accordance with legal regulations and ethical principles.

They can only be undertaken if justified scientifically and if the potential benefits for the patients justify the possible risks. The constant presence of qualified medical personnel who meet the requirements in terms of education, experience and training is also essential.