Decentralized clinical trials represents the future of clinical trials where technological solutions complement or partly replace on-site visits for the patients. Decentralized trials contribute to sustainability of the health care system, increased patient involvement and broader inclusion of patients to clinical trials as well as re-localization of treatment closer to the patient compared to traditional clinical trials.
The pilot project applied for here is well founded in the National Health and Hospital Plan 2020-23, the National Plan for Clinical Studies 2021-25 and the hospitals development plans (2035). The clinical studies, and the number of patients included in clinical trials, are expected to be doubled by 2025. To reach these goals, innovative actions must be taken, and implementation of decentralized studies through increased use of technological solutions to execute the trials in Norway will be an important contribution to reach these strategic goals.
The pilot will result in an interdisciplinary consortium of public and private partners with specialist competence within health, clinical studies and test facilities. The consortium will prepare for a main project to implement decentralized trials and infrastructure for testing eHealth solutions in Norway. User representatives and patient organizations will be central partners of the consortium and involved in the execution of the pilot and the co-creation of the main project.
The suggested pilot and main project will increase Norway’s ability to attract decentralized trials and enable clinical trial participation to a greater part of the inhabitants of Norway, and thus contribute to equality within the health care service, less drop-out and higher quality of the trials and tests.
In addition, increased competence and international network in this field will be a necessary building block in creating a sustainable ecosystem for commercialization of eHealth solutions under development.