There are several national and international sources of statistics and information on clinical studies in Sweden. No source is complete, but overall there is a lot of information that can be used to analyse and monitor the development. Data from the Swedish Ethical Review Authority give an important overview of the research that is planned, but do not contain any information on whether the studies are also implemented according to plan, or how many research subjects are participating.
Several different databases are used for registering clinical studies, finding information on the studies, and monitoring ongoing clinical studies. These databases often have a low or varied degree of coverage compared to the number of approvals from the Swedish Ethical Review Authority. Nor is the information always kept updated.
Clinical studies or clinical trials on medicinal products?
There are concepts that are important to know in order to make correct compilations and comparisons. The concepts of ‘clinical studies’ and ‘clinical trials’ are used differently, and sometimes synonymously, which leads to misunderstandings and confusion. The Swedish Research Council has therefore produced definitions of the most central concepts linked to clinical studies. For clinical studies involvning medicines, the concept of ‘clinical trials on medicinal products’ is used.
The Swedish Research Council’s definitions of concepts in medical and clinical research
Sometimes the concepts are mixed up, and the statistics for the development of clinical trials on medicinal products have been used to represent the development of clinical studies as a whole, which produces a misleading picture. One reason may be that, for many years, there has been considerably more information about clinical trials on medicinal products specifically, which is due to there having been clear legal requirements for aspects such as study registration. A further important perspective when discussing the concepts is that clinical trials on medicinal products make up 11 per cent of the total number of planned clinical studies during the years 2013–2022.
Follow-up of planned COVID-19 studies
The Swedish Research Council has compiled statistics on the COVID-19-related ethical review applications during the pandemic years 2020–2022. The statistics show how the number of approved studies developed in relation to the transmission of infection, and how the studies were distributed geographically compared to other clinical studies.
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