Using a technical framework and a national standard that makes methods and techniques available, it will be easier to perform register-based randomised clinical trials. Peter Hedman, the project manager for the development initiative, tells more about the project and its near future in the interview below.
There is a great need for randomised studies in order to get better evidence for existing treatments and to evaluate new therapies and drugs. Using registries in the form of register-based randomised clinical trials (R-RCT) has proven very effective. By developing a national standard that contains documentation on how to make a R-RCT as well as a technical framework, we make methods and techniques available, and it will be easier for more actors to perform register-based randomised clinical trials. Here at UCR (Uppsala Clinical Research Center) we have built up features that we are happy to share.
We have done lots of different activities in the project. Early in the project, we worked extensively with Sweden's registry center organizations and regional clinical nodes in order to map the conditions and needs around the country. Based on that, we developed a first version of documentation for the national guidelines. The guidelines have been reviewed and discussed and we have then proceeded with a new version based on all the comments and questions received.
We focus on adapting the technical framework for R-RCT to make it easy to customize for anyone who wants to use it. When we are done, some work remains with the documentation, but then we begin to approach the end of the project, and start the exciting work with more register-based randomised studies around Sweden.
Office for Clinical Studies, Swedish Research Council
Östra Hamngatan 26
SE-411 09 Göteborg
Phone (Swedish Research Council, switchboard):
+46 (0)31 757 41 75
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