Medical progress has not only enhanced patients’ quality of life but also contributed to a substantially greater chance of a cure and survival. Yet the need for research remains great. Our understanding of many diseases, even common ones, is still extremely rudimentary.
In very general terms, clinical research is the scientific study of the identification and treatment of diseases and health impairments. More specifically, it usually refers to research carried out directly in and with patients or healthy subjects. This includes primarily clinical trials in all phases, epidemiological and case-control studies and much of the research carried out into healthcare provision. In many cases, clinical research involves clinical trials of therapeutic products.
Assumptions in clinical research
Today, clinical research into therapies usually takes place in several countries at the same time. This enables the influence of local factors on trial results to be kept to a minimum. At the same time, a clinical trial needs enough patients in order to be carried out correctly. For less common diseases in particular, it is usually difficult to find enough patients in a single country. Clinical trials are also becoming more extensive. Clinical Phase III alone, in which a new substance is tested in a large number of patients under real-life conditions, lasts an average of two years nowadays, with bigger trials taking even longer. It generally takes over a year to recruit the participants into the trial.
The different regulations at the various trial centres pose another major challenge for clinical research. Multinational companies that carry out clinical trials in several places simultaneously need to comply with both national and local requirements. In many cases, the pharmaceutical industry also employs external contract research organisations (CRO) to assist in planning and running clinical trials. In clinical research, participants are usually recruited into trials in hospitals, necessitating close cooperation with the clinical experts.