Rokote Laboratories Finland Ltd received funding from Sitra to prepare decentralised clinical trial
The purpose of the funding granted by Sitra is to expedite the popularisation of decentralised and virtual research methods in Finland. Rokote Laboratories Finland Ltd will use the funding to prepare a research plan and application for a phase 1a clinical trial of a nasal COVID-19 vaccine.
The efficacy and safety of pharmaceuticals are studied by means of clinical trials. Traditionally trial subjects visit the trial sites multiple times for laboratory and other examinations and to obtain the drugs being studied.
Decentralisation and virtuality provide new implementation methods for clinical research, which will facilitate participation, increase the amount and quality of research data and reduce costs. Decentralised clinical trials utilise physical and digital methods that are not dependent on time and place, such as measurements conducted at home. This means that trial subjects do not always need to travel to the trial site and the investigators gain more measurement and research data at an increased frequency.
Funding to be used to build basic structures for clinical trials
Rokote Laboratories Finland Ltd is developing a nasally administered adenovirus-based COVID-19 vaccine to which the spike protein gene of the SARS-CoV-2 virus has been transferred. The vaccine aims to programme the cells of the nasopharynx to produce the SARS-CoV-2 virus spike protein that generates the immune response. The company will use the Sitra funding to plan a phase 1 a decentralised trial and prepare the permit application documentation for it.
“The phase 1a trial is the first time our vaccine will be tested on humans. It will study the functionality and administration method of the vaccine among a smaller group of subjects before the larger phase 1 clinical trial, and it will be used for deciding on the administration methods used in the later clinical trials,” explains Katriina Lavikainen, Clinical Trial Manager at Rokote Laboratories Finland Ltd.
The preliminary screening of those interested in participating in the phase 1a clinical trial and the process of requesting their consent will be carried out through online services. In addition to this, the trial subjects can, as an example, record body temperatures and any symptoms brought on by the vaccine in a mobile app, which transfers the data to the trial database. This enables the investigators to stay up to date on the condition of the subjects and contact them if necessary. Only some of the measurements as well as the laboratory tests and regular medical examinations will be conducted physically at the trial site.
“There is an increasing number of digital methods and applications for decentralised clinical trials, and they are becoming more commonplace on a global scale. This clinical trial is the first of its kind for Rokote Laboratories Finland Ltd, and we want to take a pioneering approach in designing it from the start,” Lavikainen says.
Finland has what it takes to become a trailblazer in health data usage
Decentralised clinical trials have long been a hot topic in international discussion, and countries such as Sweden and Denmark are actively promoting the new research methodology. Digital methods are also utilised elsewhere in the world to a substantial degree; for example, consent for participation is usually provided through online services.
Finland’s comprehensive health data, digitally literate citizens and innovation-friendly authorities are helping to increase the prevalence of decentralised clinical trials. Successful decentralisation shifts the focus to the research itself, supplements the range of methods and strengthens Finland’s position in the field of clinical trials.
“Sitra’s goal is to build the health care and social welfare sector in Finland into a pioneer in the usage of health data. This will provide the population with health benefits and boost society’s economic growth. We also want to promote Finland’s active role in sustainable digital development within the European region,” says Johannes Ahlqvist, specialist for Sitra’s Health Data 2030 project.
The funding is significant for Rokote Laboratories Finland Ltd
The funding granted by Sitra is very important for Rokote Laboratories Finland Ltd. The use of decentralised and virtual methods in future clinical trials will improve data quality, provide up-to-date information on the condition of the subjects, facilitate recruitment, and increase the convenience to the trial subjects.
“It is great that we can be involved in developing and deploying these new and advanced operating methods,” says Tuija Keinonen, CEO of Rokote Laboratories Finland Ltd.
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Text: Anni Turpeinen