New guidelines for registering and reporting clinical studies
The Swedish Research Council has decided to adopt new guidelines for clinical studies funded by us. As from 2022, all clinical studies shall be registered in a public database. Currently, the results of only 50–60 per cent of all clinical studies are published. Many researchers also fail to register their studies before starting.
The World Health Organisation (WHO) and the Declaration of Helsinki have guidelines and requirements for openness for research on human subjects. Clinial 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. Registration and reporting are important, both to avoid unnecessary repetition of research, and also to create opportunities for more collaboration. Researchers planning a new study need to know what research has been carried out, and what is ongoing.
The Swedish Research Council’s new guidelines are based on WHO’s guidelines and apply for clinical researchers funded by the Swedish Research Council. The guidelines mean that information about and the results of studies shall be published in a public study register, such as Clinicaltrials.gov or Researchweb.
– In practice, our new guidelines clarify what researchers who comply with good research practice are already expected to do. It is important to have openly accessible information about ongoing research, and that the research results are reported to a greater extent than is the case today. “Irrespective of whether the reason is forgetfulness, lack of incentive, or that some types of results may be difficult to publish, the goal must be that all results shall be made accessible,” says Madeleine Durbeej-Hjalt, Secretary General for Medicine and Health.
Around 200 research grants from the Swedish Research Council will be affected by the guidelines each year.
MORE WITHIN THE SAME SUBJECT AREA
Published 27 October 2022
Over the last few years, many changes have occurred in the area of ethics. The Swedish Research Council is now reviewing how best to address our ethics mandate – in relation to other actors, and the needs of our own work.
Published 12 April 2022
Increased knowledge, national coordination and regular mappings of unclear areas and obstacles. This is the way forward for improving the utilisation of health data for research and innovation. We are now beginning the work of establishing national s...
Published 6 April 2022
High quality and good opportunities to contribute to societal benefits summarise the applications approved within the research initiatives for post-COVID syndrome and follow-up studies of COVID-19 vaccines. In relation to studies of COVID-19 vaccines...