Clinical Intervention Research

Clinical intervention research is used synonymously with the research of treatment methods, which includes the research on people with the purpose of gaining greater knowledge of diseases, concerning a better prevention and diagnostics, along with how ill people are treated or cared for in the best way possible.

Clinical intervention research is comprehended by the Helsinki-II Treaty, the Act on Scientific Ethical System of Committees as well as the EU-Directive 2001/20/EF concerning the regulations on Good Clinical Practice.

In 2003, Denmark had approx. 270 PhD students with project titles that came within clinical intervention research. The methods are largely the same, no matter what kind of disease or clinical condition, the PhD project is about. The education in clinical intervention research takes place in many different small and medium-sized environments of clinical research. DIRAC is a new national initiative, established with the final purpose to implement a national coordination and advance the quality of the theoretical research education within this field. DIRAC has founded 16 new courses on a high internationally level within clinical intervention research. This is to be seen in the light of the different developments such as the termination of the human genome project, the epidemic growth in a long row of life style and infectious diseases, the striking change in population age composition and the explosively growing costs on pharmaceuticals similarly to the pharmaceutical industry exporting for more than 30 billion Danish Kroner. From the start DIRAC will establish 6 new co-financed PhD scholarships within the field of clinical intervention research, but if the co-financing allows it, this number can be increased.

Clinical intervention research forms the basis of the pharmaceutical industry’s clinical development of new drugs (phase I-IV). Valid and credible results of “lege artis” performed clinical intervention studies form the basis of the authorization of the marketing permission of new drugs of the authorities, and is at the same time the fundamental condition to the future equality assurance and prioritising in the health service.

When it comes to clinical testing, the pharmaceutical industry has gained a prescriptive right to perform this type of research. The research aims at welcoming the authorities’ growing demands for documentation of the desired and undesired effects of the pharmaceuticals as a part of the long term financial goal of the companies. However there is an additional need for clinical intervention research within fields that are not covered by the commercial interest of the industry, and this is where the public authorities must step in. The enormous commercial staking of the pharmaceutical industry and the extensive and rigid demands of the authorities has appeared to be an inappropriate setting for the development of new methods for clinical intervention research.

Simultaneously there is a great need to educate researchers, who can perform clinical intervention research, both in the pharmaceutical industry and in the public health service.

The amount of newly developed pharmaceuticals is decreasing year by year, in spite of the last 20 years of tremendously aiming at biotechnology, it is reasonable to assume, that a part of the explanation is due to the stagnation within the development of methods in clinical testing.

The Randomised Controlled Examination (Randomized Control Trial, RCT) is the golden standard by the estimation of the efficiency and security of the clinical interventions. RCT forms the basis for the testing of pharmaceuticals (phase I-IV), and also for the estimation of non-pharmacologic interventions.