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Dictionary:

Coordination of feasibilities

The purpose is to increase the number of clinical studies in Sweden by coordination study requests nationally, regionally and locally via the regional nodes. The aim is to improve the ability to provide quick, coordinated and reliable answers to study requests (feasibilities) from companies.

Background

A funding body (a company, academia or individual clinical investigator) carries out a study request (“feasibility”) to select a country or area in which to conduct a clinical study. The study requires access to clinics with the correct category of study participants, trained personnel, premises, equipment, etc. The process is time-consuming, involves many parties and is currently carried out in a variety of different ways. For the funding body, it is a complex process that is very time-consuming in terms of producing basic information ahead of a decision to locate a study in Sweden. The difficulty of finding information may result in the funding body choosing another country for the study. For clinics, the current process entails investing a lot of time in responding to study requests for studies that are then not located either in Sweden or at the clinic in question.

Implementation

In order to obtain the perspectives of all parties, two reference groups are set up. One is composed of representatives from researching pharmaceutical companies and CRO, who are the senders of study requests, and the other of representatives from clinics receiving study requests.

The project members will be interviewing the representatives of clinics in the various regions and those of pharmaceutical companies and CRO. They will also collect views and suggestions for improvements of existing processes for study requests. The result will be summarised in an introductorystudy report, which together with a process proposal will form the basis for a decision on a national test of a coordinated process. An evaluation will be made before the process moves into an implementation phase.

Goal

The following items shall be completed within the framework for the development initiative:

  • map the current process for study requests in Sweden
  • identify the needs of the various stakeholders for an improved and coordinated process
  • make proposals for a coordinated process

The information shall be summarised in the form of an introductory study. If a decision is made to implement the proposal, the implementation will take place within the framework for the same initiative.

Timeline

The development initiative started in Q1 2017 and is expected to be completed in Q4 2019. The initiative has been divided up into the following steps:

  • Preliminary study
  • Process test
  • Evaluation of process
  • Implementation of process
  • Development of system support to support the process developed