What is happening in the development initiative: Statistics and follow-up of clinical studies
Christian Thörn has been project manager for the development initiative Statistics and follow-up of clinical studies. In the interview below, Christian tells about the work that is done together with the regional nodes and what happens in the near future.
Why did we have a development initiative on statistics and follow-up of clinical studies?
There are currently no high-quality statistics for the clinical studies that are not drug trials and there is also no list or comprehensive database of ongoing studies in Sweden. Furthermore, the Swedish Research Council is required to report to the Government how we work with statistics, analysis and follow-up in this area.
In the beginning, the work was conducted as a project and the idea was to create statistics on clinical studies based on information from the former regional ethic review boards. This work was paused due to delays in the digitization of the ethical review application and the reorganization to the new Ethics Review Authority. This, in combination with the fact that it is the healthcare regions that have the mandate and the opportunity to actively follow up on ongoing clinical studies, has led us to now instead coordinate a working group with representatives from the regional nodes, who meet about four times a year to work on the challenges.
What is the aim of the working group?
The focus is on working with follow-up of ongoing studies and trying to increase the use of the study databases that are available for the healthcare regions. For example, some regions have a system called Researchweb, while others use clinicaltrials.gov to a greater extent. There is no simple solution that suits all regions, but the work will be done in different ways based on the respective regions' own conditions. The working group also provides good opportunities for learning from each other. Another important part will be local anchoring of the work with the regions' R&D management. The R&D managers are demanding information and statistics on ongoing clinical studies and need to contribute to long-term changes in order for researchers to make their current research more visible.
What happens in 2019?
The ambition is for the nodes to work within their regions on follow-up of drug trials and medical device studies, as well as the studies that the Swedish Research Council finances within clinical treatment research. Now that the new Ethics Review Authority is in place (since January 2019), it will hopefully also be easier to get information about which clinical studies are approved to start in Sweden. The new digital ethical review application means that it should be possible to obtain information about, for example, the study time frames, the estimated number of patients and names of all the principals where the study is to be conducted, which has not been practically possible before.