New supporting documents: How satellite sites can enable decentralisation of clinical studies
Clinical Studies Sweden started a project in the autumn of 2021 to find out how the satellite sites model can increase the availability of patients in Swedish healthcare to participate in clinical studies, while studies get a larger patient base and several parties can be involved. This work is now complete and has resulted in four new supporting documents.
The satellite site model allows specific study elements, such as screening, follow-up or extra visits, to be carried out at a so-called satellite site - a study clinic that may be geographically distant from the main study site, but which has a delegated or contracted responsibility for taking care of study participants and specific study work. A satellite site does not need to have a principal investigator on site, but is led by an investigator at the main site. The guidelines for decentralised clinical trials (DCT) apply to clinical trials with satellite sites. The model can be a piece of the puzzle to increase the number of clinical studies in Sweden in the long run.
Clinical Studies Sweden is now publishing new research support in the form of four supporting documents and a project report. Please contact us if you want to access the documents:
Investigated feasibility in Sweden
The overall aim and objective of the project was to investigate the feasibility of the satellite site model in clinical studies and to facilitate the use of this model for clinical studies conducted within healthcare.
“We have conducted a survey of the use of satellite sites in a number of countries and investigated how regulatory authorities think about satellite sites in selected countries within and outside the EU. We have also documented generic processes for a clinical trial that used the satellite site model. We have done this by following in the project the planning of an academically initiated trial step by step until initiation, and in parallel we have been in contact with another industry-sponsored clinical trial that planned to include satellite sites,” says Marja-Liisa Lammi Tavelin, Project Leader of the satellite sites project.
Supporting documents to facilitate use of the model
The project has concluded that there are prerequisites for conducting clinical studies with a satellite site model in Sweden, but also found areas where clarity and adaptation are especially important for studies using satellite sites. These are:
- Communication between main site and satellite site.
- Risk analysis specifically with satellite sites in mind.
- Established agreements between main site and satellite sites
- Adaptation and amendments to the study protocol and application to the Swedish Medical Products Agency.
Clinical Studies Sweden has developed four supporting documents that can facilitate and guide the use of the satellite site model in Sweden.
The supporting documents are based on the results of the project's milestones and have been developed in a fruitful collaboration with the reference group, which included representatives from the heath authority, the life sciences industry, healthcare, study support functions and lawyers within healthcare and university.
The supporting documents can be adapted to all types of clinical studies with satellite sites.
“We hope that the supporting documents can offer help in planning and implementation that can shorten the initiating process and lower the thresholds to start applying the satellite site model more widely in Sweden,” says Marja-Liisa Lammi Tavelin.
“Easier to introduce satellite sites in a structured way”
One person who believes that the model can simplify things for both study participants and research staff is Ulrika Norèn-Nyström, Senior Physician in charge of research at the Department of Paediatric Haematology and Oncology at the Children and Youth Centre at Norrland University Hospital. Ulrika works with paediatric oncology in Umeå - in a unit that has half of Sweden as its catchment area, but only a tenth of the population:
“All children diagnosed with cancer in the northern region are evaluated and treated in and from Umeå. Many treatment protocols are set up as clinical studies, which can already be partially decentralised to other paediatric clinics in the region. This has contributed to more equal care for all children with cancer in northern Sweden. But the knowledge base for this approach has been limited, so we welcome the report and the supporting documents, which I believe will make it easier to introduce satellite sites in a structured way and thereby improve the conditions for more people to be included in clinical studies,” says Ulrika Norèn-Nyström.
Decentralised studies are well suited to a country like Sweden, where many people live far from the nearest university hospital.
“Due to the long distances involved, families sometimes decline to take part in studies, when the study treatment will be administered far from home. By offering satellite sites in more places, hopefully more people will consider participating in studies,” says Ulrika Norèn-Nyström.
Some conclusions from the report
Below are brief details of the various conclusions reached by the project:
Applicability
The applicability of the model to a specific clinical study depends on many factors, such as the complexity of the study, the study-related tasks to be performed by a satellite site, the experience of each satellite site with clinical studies, the management of the investigational medicinal product, and the involvement of several regions or private healthcare providers. Studies using the satellite site model must meet the same regulatory requirements as other clinical studies, and clinical trials must be conducted according to Good Clinical Practice (GCP).
Satellite sites may be a possible approach, for example, when surgery is performed or initial treatment is given in a university hospital, but further treatment or follow-up is planned in regional hospitals or within primary care. Study participants may also be informed about the study and screened/included at the satellite site, but continue treatment at the main site.
Regulatory conditions
The regulatory prerequisites for the satellite site model for clinical studies are not fully understood in Sweden today. There is uncertainty about what is required for a study with satellite sites to be considered as having fulfilled the requirements for the principal investigator's oversight of the study, especially if the study is a clinical trial in accordance with ICH-GCP. However, there is good guidance from the Swedish Medical Products Agency and the European Medicines Agency (EMA) for decentralised clinical studies of which satellite sites are a type, and also the possibility to get regulatory advice before a planned study. The regional nodes of Clinical Studies Sweden offer research support for these studies as well as for all types of clinical studies.
More studies with decentralised elements will generate more knowledge and experience on how support processes can be developed in the future. Once the Swedish Medical Products Agency has inspected some clinical studies using the satellite site model, the sponsors and study clinics can get clear information about whether the steps taken are sufficient to meet good clinical practice (GCP) and other regulatory requirements.
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