CONEXT: Denmark | De-Centralised Trials | Regulatory Update | RWR and Regulators | RWR
IMPACT: Regulator endorsed initiative for de-centralised trials|Making clinical research results more ‘real’
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Participate in a clinical trial from the comfort of your own home. It may sound a little crazy, but it is actually possible in many respects. The Danish Medicines Agency has started a project to enable researchers and pharmaceutical companies to conduct so-called decentralised clinical trials which by means of new technologies make it easier for people to participate in clinical trials. It makes it more convenient for the participants and increases efficiency, while ultimately getting medicines to market faster for the benefit of patients.
Traditional clinical trials usually take place at one participation site – either a hospital or other research site. For participants, this could mean numerous visits to the hospital where the trial is conducted and thus hours of travelling back and forth, which could be burdensome for participants – and detrimental to the recruitment of willing participants and the diversity of the trial participants.
The Danish Medicines Agency is working together with patients, researchers and the patient industry, etc. to find ways for more elements of clinical trials to be home-based (decentralised) in the development of medicines.