- Promote clinical research according to Good Clinical Practice (ICH-GCP).
- Develop national clinical research network
- Consolidate fundamental and experimental findings by the conduct of clinical research
- Provide access to new and innovative therapeutic approaches through means of a clinical study.
CLINICAL TRIALS
Clinical trials are conducted to allow safety and efficacy data to be collected for health interventions (e.g., drugs, devices, therapy protocols). Depending on the type of product and the stage of its development, investigators enroll healthy volunteers and/or patients into small pilot studies initially, followed by larger scale studies in patients that often compare the new product with the currently prescribed treatment. Clinical trials can vary in size from a single center in one country to multicenter trials in multiple countries. (From Wikipedia, the free encyclopedia )
Clinical research is aiming to improve knowledge either of a disease or a therapy with the human being at the center of interest. In pharmacology, clinical research is dominated by studies of new innovative medicine/drugs administered to either patients or healthy volunteers, within the framework of clinical trials (clinical trials or clinical evaluations).
Chronologically, clinical trials take place in Human after experimental pharmacologic studies conducted in laboratories (preclinical stage) and are driven by:
- A Rigorous Methodology,
- Legislation (règlement grand ducal / EU directive), and
- Ethics.
Clinical studies can be conducted either in general practices, in hospitals or in specific research structures whether public or private.
Complementary to the fundamental research, clinical research represents more than half of the development time and three-quarters of the costs for a new product, and ranges from translational research, the convergence of scientific research and therapeutic know-how at the patients’ bedside, up to the large-scale clinical trials at the hospital and in general practices.
Facilitate the transfer between basic research and clinical research, by integrating the most recent data of molecular biology (genomics, proteomics, etc.) into the experimental plans of clinical trials.
Besides the scientific value, clinical research is, for the patient, a privileged access to therapeutic innovation and, for the physician, a source of acquiring new knowledge and continuous medical training and education.
Clinical trials are the only objective method today to gain knowledge about the efficiency and the safety of a new drug.
The objectives of clinical research are:
- Gain a better knowledge of the pathologies (etiology, risk factors, prevision, evolution)
- Improve the prevention, screening, diagnosis and therapies
- Adapt the knowledge to individuals in order to treat the patients and not the diseases (personalized medicine)