For research on human subjects, all studies must be registered before they start, and the results must be reported, so that both researchers and the general public can follow what the research resulted in. These are requirements and guidelines set by the World Health Organisation External link. (WHO) and the Declaration of Helsinki External link.. Many scientific journals in the area of medicine have also introduced study registration as a requirement for publication External link.. Some healthcare regions also have their own registration requirements.
It is important, from both an ethical and a scientific perspective, that it is possible to find information about all clinical studies. Having more researchers register their studies and report their results may contribute to more neutral and negative results being published. In this way, publication bias is counteracted. At the same time, the registration of studies contributes to avoiding unnecessary repetition of research, creating more efficient collaboration, and increasing research quality, as shortcomings in study design can be discovered at an early stage. This also improves the preconditions for health and medical care, and for research funding bodies making well-informed decisions.
For the clinical studies - see definitions at the bottom of the page - funded by the Swedish Research Council as from 2022, new guidelines apply. The administrating organisation is responsible for ensuring the project leader registers the study when it starts, and keeps the information updated. In the longer run, the Swedish Research Council may follow up and evaluate how well the guidelines are complied with.
Registering your study
- All clinical studies funded wholly or partly by the Swedish Research Council shall be registered in a public study register/database. More information on where to find these can be found in the fact box below.
- Please register the study before starting to include patients, or as soon as possible afterwards.
- The guidelines also apply for studies that have been started before being awarded funding from the Swedish Research Council. In these cases, the study registration must be done when the grant period starts.
- Make a study protocol (at minimum a summary of the protocol) and a statistical analysis plan (SAP) available before the study starts, either direct in the register, or stating in the register how this information can be downloaded.
- Update the registered information regularly (at minimum yearly) until the study is completed and published. Changes in the study protocol must be updated as soon as possible in the register. If the study is terminated early, the register must be updated with this information, plus the date and number of patients recruited at the time the study was terminated.
- Include information that the study is funded by the Swedish Research Council (project ID/registration number) in the register.
- Do not send the information about study registration to the Swedish Research Council.
Reporting and publishing your results
- Publish a result summary in the study register no later than 12 months after the study is concluded. For clinical trials on medicinal products, the results shall also be reported to CTIS (EU-wide database for clinical trials on medicinal products that replaces EudraCT in 2022), irrespective of whether the study is registered in several databases. This shall be done in addition to the study also being published in accordance with the Swedish Research Council’s general terms and conditions for grants.
- Include the registration number/ID in all publications, preferably in the summary/abstract of the article. This ensures better searchability in publication databases and clearer links between the publication and study registration.
Clinicaltrials.gov and Researchweb are the databases/study registers commonly used by Swedish clinical researchers. More information about and links to common registers are available on kliniskastudier.se External link. and ICMJE - Clinical Trials Registration External link..
Clinical studies are carried out on human subjects in order to study medical or health-related questions. Clinical studies can, for example, relate to the study and/or development of medicines, therapy methods or medical devices, for the purpose of improving health and medical care. All clinical studies also need approval from the Swedish Ethical Review Authority.
Examples of clinical studies are intervention studies and observation studies, including certain register-based studies.
- In intervention studies, study participants are exposed to some kind of intervention, for example a medicine, a medical device, a diet, or a surgical method. Intervention studies that include medicines or medical devices are also known as clinical trials.
- In observation studies, the study participants are observed without any influence from the researcher. Observation studies may consist of epidemiological investigations, such as cross-section studies, cohort studies, or case control studies.
- In register-based clinical studies, micro-data from national and regional quality registers or the registers of public agencies may be used to conduct epidemiological studies, or to plan, support or follow up intervention studies. Register-based clinical studies also include register-based randomised clinical trials (RRCT) and biobank studies.