What is happening in the development initiative: Satellite sites
Marja-Liisa Lammi Tavelin has been the project leader for the development initiative "Satellite sites, enabling shared study work between several healthcare principals, clinics and units". The initiative was recently finalized and in the interview below Marja_Liisa tells about the results of the initiative and what happens next.
Why have we had a development initiative relating to satellite sites?
Sweden has for various reasons in recent years lost its prominent position as a research nation regarding industry-initiated clinical trials. Access to clinical trials and academic clinical studies throughout the country is important and also a prerequisite for equal care.
When you want to include many patients in a clinical study, you use so-called multicenter studies. Then all participating centers perform all study-related tasks according to study protocols and have the same basic prerequisites for doing the study themselves. There is a need to map opportunities and obstacles for studies that are carried out at several clinics, units or healthcare authorities, but which can be considered to have been done at one site (main site with satellite sites). In these cases, the main site and satellite site (s) together perform the study-related tasks as a center of the study. The model can enable more clinical studies for more patients and more clinics.
The purpose of the pilotstudy was to carry out an external analysis and find out the needs for a satellite site model, from the perspective of health care, study participants, academia and life science.
What was the outcome of the development initiative?
The project group identified a great need for the satellite sites model among most of the relevant stakeholders, including clinical researchers, study support staff, patients, healthcare, academia and the life science industry. Aspects such as knowledge exchange, geographical spread of research, conditions for increased recruitment of study participants are highlighted as advantages of satellite sites by both clinical investigators and staff working with study support.
The patients surveyed only saw the benefits of being able to participate in studies to a greater extent. Companies and organizations also view the satellite sites model positively, but few use it. There are issues regarding safety, quality, costs and compliance with GCP as well as legal aspects, but in the discussions with regional lawyers, no direct legal obstacles emerged.
There are also synergy effects with the Swedish Medical Products Agency's project with the aim of establishing conditions for how clinical medicine trials can be carried out decentralized and virtually in Sweden.
What happens next?
The feasibility study identified a number of obstacles to the use of the satellite sites model, including the lack of clear guidelines and processes. Therefore, it is hoped that a new development initiative can be initiated on the feasibility of the satellite sites model in clinical studies. The goal is to facilitate the use of satellite sites model in the Swedish healthcare, academia and life science sector. This by following a pilot study with satellite sites and documenting the needs and content of support processes and documents and examining in more detail regulatory authorities' handling of studies with satellite sites and how satellite sites are used in other countries.