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UTVÄRDERING AV DEN KLINISKA FORSKNINGENS KVALITET VID DE LANDSTING SOM OMFATTAS AV ALF-AVTALET 41

INTRODUCTION

The

alf

agreement24 regulates the compensation from the Government to certain county councils for participating in medical education, clinical research and development of health services, i.e. “

alf

fun-ding”. In 2015, the total amount of

alf

funding for clinical research was approximately 1 700 million

sek

. Regional agreements between the county councils and the universities providing medical edu-cation complement the national

alf

agreement. In this report, the county council and the university are jointly referred to as an “

alf

region” (Table 10).

Table 10. The ALF regions, county councils and universities that are subject to the ALF agreement. Note that Region Örebro did not receive ALF funding before 2015.

ALF region County Council University Share of total ALF funding

for clinical research (2015)

Stockholm Stockholms county council Karolinska institutet 27 % Västra Götaland Region Västra Götaland University of Gothenburg 21 %

Skåne Region Skåne Lund University 20 %

Uppsala Region Uppsala Uppsala University 12 %

Västerbotten Västerbottens county council Umeå University 11 % Östergötland Region Östergötland Linköping University 8 %

Örebro Region Örebro county Örebro University 2 %

Evaluation of clinical research

The current

alf

agreement came into effect in 2015. One of the additions in the current agreement is a quality-based model for allocating a percentage of the

alf

funding. This model entails that as from 2019, 20% of the

alf

funding will be allocated based on the results of evaluation of the quality of the clinical research. The main purpose of the new allocation model and evaluation of the clinical resear-ch is to identify good examples of

alf

regions that may serve as role models for the other

alf

regions, in order to enhance the overall quality of clinical research in Sweden.

The Government has therefore commissioned the Swedish Research Council to evaluate the quality of the clinical research conducted in the county councils that are subject to the

alf

agreement.25 The results of the evaluations will be used in the new model for allocating

alf

funding.

According to the

alf

agreement, clinical research is defined as research that requires access to the structures and resources of the health services, and for which the aim is to solve a problem of ill health, or identify factors that lead to improved health.26 Clinical research in the county councils is conducted both by the county councils and the universities, and often in collaboration between the two. Thus, the evaluations include all clinical research conducted by both the county council and the university, jointly referred to as an “

alf

region” (Table 10).

The National

alf

Steering Committee has decided on the starting points for the evaluations.

Accordingly, three international expert panels have been appointed to perform the evaluations of:

the quality of the scientific output (

alf

panel 1)

the clinical significance and societal impact of the clinical research (

alf

panel 2)

the prerequisites for clinical research (

alf

panel 3).

24 U2014/07551/F National ALF agreement

25 U2016/02935/F Uppdrag att utvärdera den kliniska forskningens vetenskapliga kvalitet. (Commission to evaluate the scientific quality of clinical research); U2016/04203/F Uppdrag att utvärdera den kliniska forskningens kvalitet avseende forskningens kliniska betydelse och samhällsnytta samt forskningens förutsättningar (Commission to evaluate the quality of clinical research in terms of clinical significance and social benefit, as well as prerequisites for research).

26 Section 7, National ALF agreement

According to the National

alf

Steering Committee, the results of the evaluations should be weighted, so that the results from

alf

panel 1 accounts for the distribution of 50% of the allocation pool, and the results from

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panels 2 and 3 account for the allocation of 25% of the allocation pool respec-tively. Each panel should provide an overall assessment and group each

alf

region into one of three categories.

Inferior quality

alf

regions are only expected to be placed in this category in exceptional cases. This category is used if the evaluation of the collected documentation indicates an inferior performance in relation to the share of allocated

alf

funding, and/or the

alf

region in question has failed to fully contribu-te to the evaluation (for example by producing inferior/non-assessable self-evaluation or otherwise delivering incomplete data, etc.). Any

alf

region that ends up in this category will not be included in the panel’s allocation pool.

Good–high quality

A majority of the

alf

regions are expected to be placed in this category. This category is used if the evaluation of the collected documentation indicates a performance at a level that is to be expected based on the share of allocated

alf

funding. The

alf

regions in this category are guaranteed alloca-tion of funds from the panel’s allocaalloca-tion pool.

Very high quality

This category is used for the

alf

regions that have performed better than expected, based on the share of allocated

alf

funding. According to the National

alf

Steering Committee, this category should consist of the 1–3

alf

regions that excel and set a national example within each panel’s area.

These

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regions receive a premium of a larger share of the allocation pool than the

alf

regions

placed in category 2.

The three panel reports are summarised into a joint evaluation report by the Swedish Research Coun-cil, and delivered to the Government at the latest on 31 March 2018.

Each panel report begins with a description of the appointment of the panel and the evaluation process followed by the panel’s reflections and overall comments. The panel’s full assessments and justifications for each

alf

-region are found last in each panel report.

UTVÄRDERING AV DEN KLINISKA FORSKNINGENS KVALITET VID DE LANDSTING SOM OMFATTAS AV ALF-AVTALET 43

EVALUATION OF THE QUALITY OF