Karolinska Trial Alliance about the ongoing work on regional and national coordination

Karolinska Trial Alliance is the regional node for Stockholm and Gotland in the national collaboration Clinical Studies Sweden. Maria Englund, node manager for Karolinska Trial Alliance, tells more about the ongoing work on regional and national coordination.

Maria Englund, nodföreståndare - Karloinska Trial Alliance

How do you work with regional coordination?

Karolinska Trial Alliance (KTA) has the advantage of being a node in a geographically relatively unified area, Stockholm-Gotland. At the same time, there are very many academic, healthcare and industry players involved in clinical studies in our region.

Based on this, KTA works to create new collaborations and contacts with various actors in the Life Science industry, core facilities at KI and research staff and clinics in hospitals. In addition, we also coordinate a number of networks in the region, such as for research nurses, R & D managers and research units. We do this in order to create a platform for dialogue on common issues in clinical studies.

Overall, we strive to make make structures and functions that facilitate the planning and implementation of clinical studies available in the region. We work to be a "One Point of Contact". This means that KTA should be available for questions and / or assignments regarding clinical studies and offer support, alternatively refer the case to a relevant actor in the region. We also accept feasibilities and help identify interested practitioners and / or clinics for both industry-sponsored and academic clinical studies in all therapeutic areas.

Among other things, KTA is working on report describing how a research nurse-pool could be coordinated and functioning. In the framework of statistics, KTA has also conducted a regional preliminary study to investigate the current situation and the need for collecting statistics in the Stockholm-Gotland region. We do this in order to provide a recommendation for continued work on the development of a process and possibly a database for reporting and extracting descriptive statistics on clinical studies.

We will continue the mapping of actors and identification of new needs in the future.

How does Karolinska Trial Alliance work with national coordination and what does it mean for operations within the Stockholm-Gotland region?

As a regional node in the collaboration Clinical Studies Sweden, we work with development initiatives to find solutions that can be applied nationally and regionally. Ongoing coordination is also taking place between nodes through nodal meetings and in the networks for communicators and lawyers, as well as in the work of the National Conference on Clinical Studies. In addition, cooperation with other nodes has also increased in general, for example. in data management, contractual matters and phase I studies.

KTA also participates in and leads a number of networks nationwide, some new and some existing since several years. A newly established network, for example, is SwedPedMed, where the focus is on collaborating around children's studies in Sweden and thereby allowing more clinical studies. Another network that has existed for several years is Clinical Studies in Primary Care, where the focus is on sharing knowledge and experiences regarding clinical studies in primary and outpatient care.

A concrete example of national coordination is the GCP course for managers now spread nationally. By 2017, the Swedish Medical Products Agency and KTA have drawn up a training package on research ethics, regulations and GCP, which is now mandatory for managers in Stockholm County Council as part of the Macchiarini scandal action program. It also proved to be a national need, and therefore, the Swedish Medical Product Agency developed a quality assured course package that all nodes can share. To ensure equal content and quality, a "Train the trainer" concept is offered. Representatives from the nodes are trained to pass on their knowledge and training material to additional colleagues who can also complete education. This way we can increase the spread rate and ensure that more healthcare professionals are reached by the information. A similar concept will be drawn up for the completed development initiative "Standardized Agreement Process" to implement the result.

What do you think is important in this cooperation to create long-term sustainability?

In order for Clinical Studies Sweden to be a long-term and sustainable collaboration, we need to work together and have ongoing dialogue between academia, healthcare and industry.

We now have the opportunity to improve the conditions by influencing and developing the processes for clinical studies. One example is the development initiatives, where both the nodes, the Swedish Research Council and reference groups with representatives from academia, health and industry participate.

However, it is important that the dialogue continues after the end of the initiatives and that we maintain what we agree. We must create a constructive and positive dialogue!