Forum for dialogue on decentralised clinical trials
To ensure strong interactions between authorities, patients, researchers and the industry, we and Trial Nation have set up a forum for dialogue. The formalities and participants are available in the terms of reference (pdf, in Danish).
The Danish Medicines Agency wishes to collaborate with clinical trial sponsors to conduct a small number of pilot projects with sub-elements of decentralised clinical trials. In these pilot projects, the sponsors and the Danish Medicines Agency will work closely together regarding the elements that challenge the traditional framework of clinical trials, and the experience gained will be thoroughly assessed. Please note that this is not confined to the members of the forum for dialogue, and sponsors are welcome to contact us if this is of interest to them. Please also note that we encourage applicants to seek regulatory scientific advice before submitting an application for a decentralised clinical trial. It must appear clearly from the application for scientific advice that it concerns advice regarding a decentralised clinical trial.
The knowledge gained from the project and this forum for dialogue will be regularly published through implementation in our national guidelines. The Danish Medicines Agency will also hold open meetings in 2021 for anyone interested.