One way of finding information or statistics about clinical studies is to look at the number of applications for ethical approval. The only type of study for which there are comprehensive statistics are clinical trials using medicines, which need approval from the Ethical Review Authority, an EudraCT number and approval from the Medical Products Agency before starting.
The Ethical Review Authority keeps annual statistics
Research on living or deceased persons, on biological material from humans, or research that involves handling sensitive personal data must by law be reviewed and approved by the Ethical Review Authority. The agency (previously six regional ethical vetting boards) keep annual statistics of the number of applications handled, and information about all the clinical studies that have been granted ethical approval.
In 2018, the ethical review boards, as existed then, handled a total of around 2 450 new applications, of which 10 % related to intervention studies using medicines. The rest of the applications concerned other intervention studies, observation studies, diagnostic studies and qualitative studies. The diagram below shows the annual development of the number of applications since 2008.
On the Swedish Research Council's website, data from the ethics review boards is distributed among the various ALF regions (in Swedish). The figures show that just over 86% of the approved new applications in 2017 came from researchers active in an ALF region.
Statistics are available for clinical trials using medicines
For clinical trials with medicines, authorisation from the Medical Products Agency is also required. All applications for medicine trials registered with the Medical Products Agency are also registered in the European study database EudraCT. The European Medicines Agency (EMA) is responsible for EudraCT. The study database is available in the EU Clinical Trials Register, and includes both commercial and non-commercial medicine trials. Here you can find information about ongoing and completed studies using search categories such as medical condition, medicine, university or company. Information on Phase 1 studies is not publicly available.
The Swedish Medical Products Agency produces statistics on clinical trials in its information series “Information från Läkemedelsverket“. Lif, the trade association for the research-based pharmaceutical industry in Sweden, also produces statistics of the member companies’ pre-clinical and clinical research. Statistics from 2015 show that the pharmaceuticals industry was then Sweden’s second largest net exporting sector, and that the number of commercial clinical trials using medicines had fallen, while the number of non-commercial medicine trials remained at a fairly constant level. Since the middle of the 2000s, the number of applications for clinical trials using medicines from Lif members had fallen from just below 300 per year to just over 100.
To supplement the picture of medicine research in Sweden, the Swedish Research Council has produced two reports with statistics on medicine trials in Sweden. The first report deals with the planned patient recruitment and shows that the sizes of the different subject areas within medicine research differ significantly, depending on whether the classification is based on the number of patients or number of trials. Comparison to the number of patients on the Swedish National Board of Health and Welfare’s patient register also shows that only a small percentage of all patients take part in medicine trials. The proportion of children and youths taking part in medicine trials is low, at around five per cent. When it comes to Swedish patients in international trials located in Sweden, the proportion is around four per cent.
The second report shows how academic and industry-sponsored medicine trials differ in design, in terms of the estimated number of patients and the number of clinics planned to be included in the study. The report provides a picture of how medicine trials are distributed geographically in Sweden, which provides a perspective on the varying opportunities for patients to take part depending on where they live. The report also includes visualisations of the degree to which the healthcare regions participate in the same/joint trials. Academic medicine trials are usually only conducted within one healthcare region, while the majority of industry-sponsored trials have participating clinics in several regions. It also emerges that industry-sponsored medicine trials cover considerably fewer planned patients per clinic than academic trials do.
The U.S. Food and Drug Administration (FDA) has requirements for registration and result reporting of studies using medicines carried out in the USA. The studies are registered in clinicaltrials.gov. Just like in EudraCT, in this database you can find studies based on medical condition, medicine or where they are carried out.
In order for a medicine to be approved for marketing in both USA and Europe, the studies must be registered in both EudraCT and in clinicaltrials.gov. When it comes to Swedish studies, it is therefore primarily commercial clinical trials using medicines that are registered in clinicaltrials.gov, but it is possible to register all types of clinical studies in this database.
WHO summarises data from other databases in its own searchable database for clinical trials, International Clinical Trials Registry (ICTRP). The aim of ICTRP is to become a fully comprehensive database of ongoing and concluded clinical studies across the whole world.
Statistics for clinical trials using medical devices
Clinical trials involving non-CE-marked medical devices or medical devices that are CE-marked for other use than that intended in the study shall be registered by the Medical Products Agency. Over the last few years, the proportion of trials involving medical devices registered with the Medical Products Agency has represented less than one tenth of the total number of applications. In 2014, the proportion of medical device applications was 8 per cent.
Advantages of registering studies that do not involve medicines
There is no legal registration requirement for studies that are not clinical trials with medicines, that is to say other clinical trials, observational studies, diagnostic studies or qualitative studies. However, there are ethical principles to relate to as well as other benefits of registering your clinical study. WHO lists the following:
- Registering clinical studies is a prerequisite for enabling health and medical care to make well-informed decisions that take into account all available knowledge
- It counteracts only some results being reported
- Unnecessary repetition of research can be avoided when researchers and funding bodies have the chance of finding information about similar or identical studies that have already been carried out
- It makes it easier to understand where there are knowledge gaps
- Recruitment of study participants can be quicker if researchers and healthcare personnel can find information on ongoing studies more quickly
- Collaboration within clinical research becomes more efficient if researchers can find information about studies that are in progress
- Research quality increases if reviewers can identify at an early stage studies where the study design can be improved
Many respected scientific periodicals require studies to be registered in order for the results to be approved for publication, and in practice there is thus often a registration requirement even for studies that are not clinical trials using medicines.
A database recognised by WHO and the International Committee of Medical Journal Editors (ICMJE) is ISRCTN Registry. This database is operated by BioMed Central, which is a publisher of freely available publication of scientific information. In the ISRCTN Registry, both clinical trials and observational studies may be registered, and it can be searched for studies in progress or completed, and for information on study details and results. Clinicaltrials.gov can also be used to register studies for publication purposes.
Bibliometry and information on clinical research are found in the ALF-evaluations
Within the public sector, Swedish clinical research is carried out mainly at universities and higher education institutions. The two largest sources of funding are the R&D funds of county councils and the “ALF” contribution from the Government. ALF is a national agreement between the Government and seven county councils on physician training and research.
In 2015, a new ALF agreement came into force. This agreement has been entered into between the Swedish Association of Local Authorities and Regions (SKR) and the Government offices, and includes a new allocation model, where one fifth of research funds will be allocated according to the quality of clinical research. The Swedish Research Council and the National Board of Health and Welfare have been mandated by the Government to evaluate the quality of research. This is done through expert assessment of aspects such as the prerequisites of research, the clinical importance of the research conducted and the results in the form of number of scientific publications and citations. The first evaluation was published in March 2018 and bibliometry is accounted for separately. Full evaluations are then planned to be conducted every fourth year.
Some information can be downloaded from Researchweb
Many regions use Researchweb as an application system for, for example, ALF funds or other types of regional research funds. Researchweb is also used as a project database displayed under the name FoU i Sverige. There is some information about ongoing studies here, and you can search for research projects based on the topic and the workplace.
Register of cancer studies in Sweden
For purposes such as facilitating recruitment of study participants and reinforcing and supporting Swedish clinical cancer research, the Regional Cancer Centres in Collaboration (RCC) and the Network for University Hospitals’ Trial Unites within oncology have jointly produced a database with current clinical studies within cancer care. The register is searchable in respect of cancer form, participating hospital, words in the Swedish title and study type.
Regional statistical reports
Forum Middle Sweden has established a process for collecting information on ongoing clinical studies in the healthcare region’s seven subsidiary regions. The work results in, among other things, annual statistical reports. In the latest report on ongoing studies during 2019, all studies that require approval from the Ethical Review Authority (EPM) have been mapped. The report also describes what collaboration looks like between the different regions and how the number of studies is distributed in different diagnostic areas.