National standard R-RCT

The purpose was to develop a national standard for R-RCT (Register-based Randomised Clinical Trials) that facilitates and increases the number of register-based randomised clinical studies.

The number of randomised clinical trials (RCT), primarily medicine studies, has fallen in Sweden over the last few years. This is detrimental to the opportunities of healthcare to take active part in developing better therapy methods.

One of the reasons for the reduction in the number of studies is the high implementation cost. This is due to factors such as the high cost of data collection, but also because RCT requires a lot of personnel. This can be a challenge because of the currently limited resources of healthcare. As R-RCT is a new area, there are as yet no standards for it, and R-RCT is not mentioned in the current regulatory framework for studies involving medicines.


The project delivered a quality-assured national standardised framework that offers the opportunity to carry out R-RCT in a quality register. The purpose was to:

  • reduce the cost of conducting R-RCT studies
  • reduce the implementation time through increased rate of inclusion
  • increase the number of studies located in Sweden through the establishment of a publicly available standardised national framework/guidelines for R-RCT studies

Time plan

The development initiative started in Q1 2017 and was expected to be completed in Q1 2018.