Clinical trials are research studies performed on volunteers with the purpose of answering some specific scientific questions. Clinical studies try to answer questions related to prevention, diagnosis and development of new medicines or therapeutic methods. At the same time these studies can often help specialists obtain valuable information regarding the biological mechanism of diseases.
Clinical studies are among the last steps in the long process of drug development, which starts out in a laboratory, it continues with pre-clinical testing on animals and finally, after the drug is proven to be safe and efficient on animals, the process continues with phase I clinical trials and bioequivalence studies.
An essential step in the development process for new therapies, clinical trials allow researchers to establish appropriate dosage and administration for a drug and also provide the means to confirm effectiveness of a new drug in humans, at the same time identifying any type of adverse drug reactions. Authorities use data from clinical studies to search for proof that new therapies are at least as safe and efficient, or even safer and more efficient than existing therapies. The unfolding of a clinical trial is the same all over the world, regulated by international laws and guidelines.
Participation in clinical trials gives patients the possibility to gain access to new medications, innovative and promising therapies before these are made available on the market.
Even though there is no guarantee that taking part in a clinical trial will have positive effects or that the patient will receive the new therapy that is being tested in the trial, volunteers participating in trials play an essential role in improving treatment for future patients.
To ensure that a clinical trial unfolds successfully, the dedication and commitment of medical and research personnel as well as that of the patients' is needed. That’s why it is very important to understand the whole process of clinical trials, the benefits and risks involved in participating, as well as the possibilities through which patients and medical staff can locate clinical trials in which they would like to participate.