Few patients participate in medicine trials
The Swedish Research Council has analyzed the development of clinical trials with medicines in Sweden between 2010 and 2016 by focusing on the number of patients scheduled to participate in trials. The report shows, among other things, that regardless of the diagnosis area, few Swedish patients participate in trials and the proportion of children and adolescents is low.
Between 2010 and 2013, the number of medicine trials in Sweden has remained stable, while the planned recruitment of patients has varied between 12,900 and 38,400 per year. The number of patients per study varied between 50 and 150. Regardless of the diagnosis area, there is a small proportion of patients taking part in trials. The highest proportion is patients diagnosed with blood disorders or disorders in the immune system, where 1.5 percent participate in trials.
‒ By highlighting patient participation, we broaden the image of clinical trials with medicines, which until now often focused on the number of trials. The low proportion of patients in medicine trials means great opportunities to involve more. In the future it would be interesting to look in to whether the opportunity to participate in trials differs between different regions, says Håkan Billig, chairman of the Committee för Clinical Studies between 2014-2017.
Most patients participate in trials concerning cardiovascular disease
The size of the different topics in medicine research differs depending on whether the division is based on the number of patients or the number of trials. When looking at the number of patients, cardiovascular disease along with lung diseases is the largest research area. When looking at the number of trials, the cancer area is the largest. The summary also shows that the proportion of children and adolescents in clinical trials with medicines is low, around five percent, compared with 58 percent of participants in working age and 37 percent of particapnts over the age of 65.
‒ There has been a lot of discussion about whether more clinical studies are needed in pediatrics. With regards to clinical trials with medicines, we now at least have real numbers to discuss.
Four percent of patients in international trials are Swedish
71 percent of the clinical trials with medicines that were located to Sweden during the period 2010-2016 were international. These trials accounted for 39 percent of the recruited patients and recruited on average 1,060 patients, of which 40 were Swedish. National drug trials recruited on average 170 patients.
‒ It is obvious that large national trials involve the majority of Swedish patients, but it is important to maintain or to increase participation in international studies in order for new medicines to be adapted to the conditions of Swedish patients.
Clinical trials on medicines constitute ten percent of the research approved by the Ethics Review Board each year.
‒ The results of the report should be used with caution in terms of interpretation of clinical studies as a whole, states Håkan Billig.
Take part of the entire report "Statistik för läkemedelsprövningar ur ett patientperspektiv" (in Swedish with a summary in English)
For questions about the report, contact Håkan Billig, chairman of the Clinical Studies Committee between 2014-2017, phone +46-70-884 09 76.
For questions about management of the statistics in the report, contact Christian Thörn, phone +46-31-757 41 62.
The Swedish Research Council has the task of supporting and developing the conditions for clinical studies in Sweden, as well as reporting statistics, analysis and follow-up in the area. The report is based on data from the period 2010-2016. Data sources are the European database for drug trials (EudraCT) with data for planned patient recruitment and the National Board of Health and Welfare's register for number of diagnoses for Swedish patients.