A qualitative study on clinical research in Finland: fragmented governance and volume in the 2000s

Abstract

ObjectivesAlthough concerns over clinical research have been expressed, the governance of clinical research has been little studied. The aim was to describe research policy, volume, funding and concerns over clinical research in Finland.DesignA qualitative study and the data were collected from various sources, including documents, statistics and semistructured expert interviews.SettingFinland.ResultsWe found no national policy for clinical research. Many actors were responsible for facilitating, directing, regulating and funding clinical research, but no actor had the main responsibility. Health professionals were the main drivers for clinical research. The role of the health ministry was small. The ministry distributed state money for clinical research in health services (EVO-money), but did not use it to direct research. Municipalities responsible for health services or national health insurance had little interest in clinical research. The Academy of Finland had had initiatives to promote clinical research, but they had not materialised in funding. Clinical research was common and internationally competitive, but its volume had declined relatively in the 2000s. Industry was an important private funder, mainly supporting drug trials made for licensing purposes. Drug trials without an outside sponsor (academic projects) declined between 2002 and 2010. The funding and its targeting and amount were no one's responsibility. Concerns over clinical research were similar as in other countries, but it had appeared late.ConclusionsOur results suggest fragmented governance and funding in clinical research. The unsystematic research environment has not prevented clinical research from flourishing, but the public health relevance of the research carried out and its sustainability are unclear.

Clinical research in Finland in 2002 and 2007: quantity and type

“…In our previous study [11] we reported data from national statistics, concluding that the quality and quantity of Finnish clinical research had been high compared to some other countries, but volume had declined in the 2000s [15]. One possible factor that reduced the number of clinical projects is the European Clinical Trials Directive, which came into force in 2004 in Finland [16].…”

“…However, the number of different PIs declined between 2002 and 2007, and the number of projects per single PI increased. In a 2006 survey, a high proportion of physicians reported engagement in research (clinical research was not specified), but later surveys suggested that in many hospitals and health centers, the possibilities to undertake clinical research were deteriorating, particularly due to the burden of routine patient care and a lack of time [11]. …”

“…Municipalities allowed health professionals to use their working hours for clinical research, but they did not directly fund clinical research [11]. The work time compensation could be an important support for encouraging research, but in practice it is rather limited as the health professionals’ work-load often prevents research during working hours.…”

“…Regardless of these concerns, clinical research or clinical trials as a research institution have not been extensively studied. Previously, we have mapped the situation in one European country, Finland, using various sources [11]. Our results suggested that the governance and funding of clinical research in Finland was fragmented.…”

“…A comparison to five European countries showed that research and development (R&D) expenses in general were high in Finland, but much of that was due to R&D undertaken by corporations [11]. Connections between public and private research units were more common in Finland than in the comparison countries (Denmark, Ireland, the Netherlands, Norway and Switzerland) [12].…”