Applied clinical research
Applied clinical research is the foundation of evidence based medical practice. Based on scientific theories as well as clinical experience, it aims to provide accurate and verifiable knowledge about the effects of prophylactic intervention, diagnostic procedures and therapeutic treatment.
Clinical decisions should whenever possible be based on results from applied clinical research in addition to empathy and experience. Investigations indicate that "only" 50-80% of treatments in medical units and 20-50% of treatments in surgical units are well proven scientifically..
Definition of Applied clinical research
The Norwegian Research Council (NRC) has defined applied clinical research as the foundation of direct improvement in diagnosis, treatment and care of patients, and better cost-utilisation of health funds. These goals are achieved by three types of research.
- Basic research addresses epidemiological research as well as biological and psychological fundamental research. Although this research can be classified as applied clinical research if it has immediate relevance for the daily clinic, it is usually not included in the term applied clinical research.
- Clinical research in the usual sense. The golden standard is the controlled, randomised clinical trial, often in large groups of patients. Such projects are time and resource consuming. Observational studies, use of health records and medical method development are other forms of clinical research.
- Health Services Research. This is research based on established treatments or standards. Requirements, distribution, organisation and resource needs is measured to improve efficiency, quality and fairness.
The position of Applied clinical research in Norway
Norway is well suited for applied clinical research. We have a transparent system for treatment distribution, a coordinated and unified public health service with good contact between the different departments. And the population is motivated for clinical research.
The Health Region Mid-Norway benefits from good cooperation between the hospitals and the region has many highly qualified professionals. The infrastructure includes Helsenett and IT solutions taylored to facilitate medical research. NTNU is developing new medical technology, large health surveys are conducted in the region and the applied clinical research is given priority.
Despite the fact that Norway is well suited for clinical research, key figures for medical and health care research in 1999 show that the relative activity of clinical research in Norway is lower and has less "impact" (citation scores) than in the other Nordic countries. Production of scientific publications is low compared to most other OECD countries. However, the last few years a significant improvement has emerged.
Applied clinical research will be strengthened
While the pharmaceutical industry accounts for the bulk of applied clinical research in Norway, NRC wishes to strengthen the clinical research in areas where the industry has less or no interests.
Why should Applied clinical research be strengthened?
A large part of the activity in the health care system lacks scientific evaluation, and only a small number of diagnostic and therapeutic procedures are examined in terms of long-term health benefits. Not only is applied clinical research needed to assess the efficacy and harm of both established and new diagnostic and therapeutic practice, it is also a prerequisite for maintaining and renewing skills in Norwegian hospitals. It is important to have independent (often university-based) applied clinical research in addition to the industrially initiated research. Although these types of research are complementary, the incentive will often be different in terms of relations between medical, social and economic values.
In addition applied clinical research is in the long term good health economics. There are several examples of costly treatment regimes with no therapeutic benefit. The results of applied clinical research are meant to be applied to improve diagnosis and treatment, effects being expressed as significant outcomes such as morbidity, mortality, disability, pain, discomfort, quality of life, health, finances, etc.
How will the applied clinical research be strengthened
- Competence centres are established in all health regions. They are focused on establishing skill developing programs, generating regional networks, and being a source of advice regarding research planning, statistics and epidemiology.
- Project Support. More funds will be allocated to support projects. This economical support can be for salaries, management and necessary equipment.
- Clinical scholarship. The intention is to give clinicians time to do research. This is a priority intended to contribute to structural changes at the hospitals.
How to define a clinical research project?
Clinical trials can be very different. Depending on the nature of the experiment, the projects are divided into Phase I to IV. This has to be considered when projects are implemented.
Every research project is described in a research protocol. Such a protocol is required by the authorities and guides the researchers through the details of the project. Structure and content of the protocol depend on the type of project and what stage it is in. There should always be a clearly defined primary outcome. The protocol should also include information about the underlying motives of the project, the material, the intervention / treatment, method of evaluation, sample size, the expected effect, study design including randomisation, practical implementation, forms (CRF) and data handling, what method to use for data analysis, economics, how the resulting data is planned to be presented, ethical sides, etc. Specifications of obligations and rights in relation to the sponsors are given.
Once the protocol has been written, the project must be approved by the appropriate parties, such as the Regional Committee for Medical Research Ethics, Norwegian Medicines Control, Data Inspectorate, the hospital's internal committees, etc.
All personnel involved in a study must receive the necessary information and training. A schedule for the analysis of collected data is sett up, to enable participants to draw preliminary conclusions. Problems occurring during a clinical project often generate ideas about new research projects.
The results of a study are to be presented as lectures, posters, articles in scientific papers and popular science presentations. Implementation of new procedures in the clinic should also be considered.
Why should one conduct applied clinical research?
Personnel with experience in applied clinical research will be better health workers for their patients by improving critical thinking in the clinical decision-making process. Moreover, one should undertake research for future patients, the local work environment, and Norwegian medicine. In addition to making you a better health worker, research offers you education, satisfaction, and enrichment of clinical practice. Research provides career opportunities, it is gradually becoming a demand and it gives status both in the public and among patients.