The SMART pragmatic clinical trial toolbox

Purpose and goal

The purpose of the project is to produce a complete toolbox to carry out pragmatic diabetes studies with the help of doctors and patients in primary care. The goal is to pave the way for the SMART study, which can then be followed by other studies. The project has shown that the developed tools meet the needs of the study. The toolbox can be reused and further developed for future clinical trials, which will thus be both cheaper and more effective.

Expected results and effects

The results of the project largely reached the desired results. The part that has not yet been resolved is the electronic informed consent module, which will be resolved during the exension of the project. This means that the expectations on the digital toolbox that the project proved possible will be met. Hence, the SMART study will be able to carry out once budget and all permits are in place for that study.

Planned approach and implementation

The plan has been to work agile with the various parties involved in the project. Joint workshops have been done, complemented with own work. The own work has been followed through skype, chat and phone. The setup has proven to work well for this type of project. The various parties have been able to work independently with the possibility of rapid reconciliation if necessary. Occasionally, the project has competed with other commitments of the various parties, which has caused a certain amount of delay in the project, but nothing that could not be handled properly.