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Pilot study: Satellite sites – enabling shared study work between several healthcare principals, clinics and units

The purpose of the development initiative is to investigate whether the preconditions for conducting clinical studies in Sweden are strengthened by using satellite sites, thus enabling several clinics and study participants to take part in clinical studies. The pilot study shall result in documentation that describes any opportunities and challenges of satellite sites. The project shall also identify the support that the nodes within Clinical Studies Sweden could offer to studies conducted according to a satellite site model.

Bakgrund

The traditional format for conducting a clinical medicine trial at a specific hospital clinic, or within a designated speciality, does not favour the preconditions for including study participants from across the whole country. An increasing number of medicine trials are currently conducted on small sub-populations with specific diagnoses, and to ensure a sufficient number of study participants, the entire population base of Sweden needs to be used. Academic studies also need to be able to include participants from the whole country, and to distribute study tasks between several principals.

The model with satellite sites means that some parts of the study work can be conducted at clinics other than the primary site, such as screening, follow-up and extra appointments. Under certain circumstances, all the study appointments can be conducted at another clinic.

Mål och genomförande

The goal is to use contemporary environment and needs analysis to:

  • identify challenges and opportunities of using satellite sites
  • investigate what type of studies have used models similar to satellite sites, and consider advantages and disadvantages
  • investigate what type of support the nodes within Clinical Studies Sweden could contribute when satellite sites are used
  • investigate whether there is a need and interest in developing the use of satellite sites, and if so, to conduct a more in-depth development of a model for Sweden.

Tidsplan

The pilot study started in Q4 2019 and is expected to be completed at the end of Q4 2020.