The Danish Medicines Agency has issued guidance on the opportunities and challenges associated with conducting decentralized clinical trials that allow patients to participate in research from their homes.
The guideline reflects the knowledge and feedback that the Danish regulator has gathered from an ongoing national project on decentralized trials launched earlier this year. The project resulted in the DMA launching a pilot on decentralized trials and establishing a dialogue forum comprising all affected stakeholders, such as ethics committees, patients, companies, researchers and regulatory authorities