Feasibility request – a nationally coordinated service
The development initiative Coordination of feasibilities has developed a service, Country/Early feasibility, to discover whether a clinical study is feasible in Sweden. In the interview below, Abraham Mellkvist-Roos, project leader, tells us more about this, and what will happen next.
What is happening in the development initiative Coordination of feasibilities?
The new service aimed at investigating efficiently whether a clinical study is feasible in Sweden that the project team has developed is now being launched by Clinical Studies Sweden. By looking at successful initiatives in other countries and interviewing representatives from both the life science industry and clinical investigators in health and medical care, the project team identified both obstacles to and needs for clinical studies. Among life science companies, we identified a major need to improve the opportunities for investigating whether it is feasible to conduct a clinical study in Sweden.
Why is it important to make country feasibility requests easier?
Before life science companies decide which country a study shall be conducted in, they investigate factors such as the number of potential study participants, therapy guidelines in the country in question, and access to infrastructure and personnel. It is therefore important that health and medical care can provide the information requested, and a quick answer increases the chance that the study will be located in the country. In addition to creating preconditions for knowledge-based healthcare that is safe for patients, clinical studies also contribute to quicker implementation of new innovative treatments and methods. The importance of clinical studies has also be recognised in the Government’s new life science strategy, which has an increase in the number of company-initiated clinical studies as one of its goals. We hope that the new service for country feasibility requests that we have designed within the development initiative will contribute to increase the number of company-initiated clinical studies in Sweden.
How does the service with country feasibility requests work?
Life science companies and academic researchers can use the service that offers a portal for country feasibility requests aimed at Swedish healthcare. When a feasibility request is sent to any of the nodes within Clinical Studies Sweden, a rapid national distribution is made to a network of experienced clinical investigators. To ensure a more efficient process, a standardised request form is used that the clinical investigators reply to. The feedback received by the nodes is immediately sent to the person or company making the request.
The service means it is possible to get an indication of feasibility specifically based on national therapy guidelines in Sweden, as well as overall feedback on the study design.
The continued work on a clinical study is also made easier, as the clinical investigators contacted are able to state whether they would be interested in the study.
The process and working methods was recently tested in a pilot study, with very good results. The time frames set were achieved, despite being ambitious in international comparison.
How can the work with feasibility requests be simplified further?
A survey conducted within the development initiative showed great interest in a digital solution that matches investigators and clinics with current feasibility requests. We will be doing further work on this within the initiative.
Information and contact
Further information and contact details for the service are available at Clinical Studies Sweden: Country feasibility.