Why are they so important?
Clinical trials are special purpose research programmes dedicated to therapeutic agents, and conducted with the participation of patients, that aim at determining whether a new form of therapy is safe, and how effective it is. The clinical trials can also be conducted in order to check new disease prevention modalities. As a result of the research, new modalities for prevention, diagnosis or treatment of specific diseases are set out. The clinical trials do directly contribute to the progress in medicine.
In the last several decades, the progress in medicine – including the development of many new drugs and therapies – has made us be able to cope today with numerous diseases that until recently were incurable.
The clinical trials are conducted according to strict rules, i.e., in accordance with the Good Clinical Practice guidelines (in short, the GCP), with respect for the rights and guaranteeing the safety of patients – study participants.
What are clinical trials based on?
The most important goal of clinical research conducted in clinical research centres is to confirm that drugs that end up in the hands of doctors and patients are safe and effective.
The clinical trials constitute a very important part of the process of creating a new therapeutic agent; about 2/3 of the average cost of work on a molecule are related to the clinical research, which are an important factor in the development of medicine.
Taking into account the increasing sophistication of medical technologies, used in novel drugs, and the need to adapt to ever-higher standards of drug safety – the role of clinical trials is steadily growing.
The clinical trial are a series of medical examinations with the participation of patients and/or healthy volunteers. Their purpose is to determine whether a specific drug or therapy brings the expected medical benefit and, at the same time, to establish whether it is effective and safe for the patient.
A typical process includes four phases of clinical research (preceded by a phase of preclinical studies during which, in cellular and animal models, the concept of new therapeutic method is being verified). In accordance with the standards of Good Clinical Practice (GCP).