Preparation of decentralised drug trials
Drug trials are increasingly using digital methods, such as measurements taken by patients at home, to facilitate the daily routines of researchers and patients. The projects involve preparing materials for the drug trial permit application process.
What is it about?
Decentralised drug trials have long been at the core of international discussions in the pharmaceutical industry. The term refers to clinical medical trials that use physical and digital methods that are independent of time and place, such as interventions or measurements carried out at the patient’s home. A significant portion of current drug trials already use digital methods, such as online consent.
However, the decentralisation of trials could be used much more extensively. Successful decentralisation makes the patients’ daily routines easier and facilitates participation in trials. Decentralised methods complement the range of tools used by trials and can thus bolster Finland’s status in clinical medical trials.
Sitra aims to increase the number of decentralised clinical medical trials in Finland. It mainly supports research groups in applying for a permit from the Finnish Medical Agency (Fimea) or corresponding agency to conduct trials in which the use of decentralised methods, such as remote measurements or drug administration at the patient’s home, play a key role. Funding can also be provided for the preparation of a research plan, provided that it is preparatory to the application for a research permit.
Projects in progress
The projects that were chosen on the basis of the call for funding broadly cover the drug trial field and represent different diseases and diverse methods utilised in them. There are currently three on-going projects, which are scheduled to end by summer 2023.
Effects of medicines on RCVS syndrome that causes severe headache
The treatment of the reversible cerebral vasoconstriction syndrome (RCVS), which causes sudden, debilitating headaches, is currently based on expert opinion and observation due to the lack of data from randomised medical trials. The syndrome is associated with the constriction and expansion of cerebral arteries. RCVS can be triggered by several factors, such as substance abuse or childbirth. The aim of the trial is to find out how effective drugs (nimodipine and amlodipine) are in reducing the symptoms. Surveys concerning symptoms are carried out digitally and the research personnel are trained to use decentralised methods.
Project implemented by: Hospital District of Helsinki and Uusimaa, Maria Mironova, maria.mironova (at) hus.fi
Nasally administered Covid-19 vaccine
This medical trial, conducted by Rokote Labs, is investigating the effects of a nasally administered coronavirus vaccine against SARS-CoV-2. The trial uses decentralised methods including the recruitment of patient groups, pre-assessment, providing consent and the measurement of patients’ body temperature. The funding covers both the application for a research permit and preparation of a research plan.
Project implemented by: Rokote Laboratories Finland Oy, Tuija Keinonen, tuija.keinonen (at) rokote.com
Digital diagnostics and monitoring of breast cancer
Breast cancer is the most commonly diagnosed cancer in women and a common cause of mortality. However, there is still room for improvement in the monitoring of the disease. The trial aims to promote personalised care, diagnostics and the use of digital monitoring of symptoms and treatment. Funding is also being used for customising the mobile app used in the trial.
Project implemented by: University of Jyväskylä, Sauli Vuoti, sauli.j.vuoti (at) jyu.fi
