Service System Department, National Institute for Health and Welfare, Helsinki, Finland.
BMJ Open. 2013 Feb 13;3(2). doi: 10.1136/bmjopen-2012-001856. Print 2013.
Although 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.
A qualitative study and the data were collected from various sources, including documents, statistics and semistructured expert interviews.
Finland.
We 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.
Our 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.
尽管人们对临床研究表示担忧,但对临床研究的治理却鲜有研究。本研究旨在描述芬兰的临床研究政策、数量、资金和对临床研究的关注。
定性研究,数据来自各种来源,包括文件、统计数据和半结构化专家访谈。
芬兰。
我们没有发现国家层面的临床研究政策。许多行为体负责促进、指导、监管和资助临床研究,但没有任何一个行为体承担主要责任。卫生专业人员是临床研究的主要推动者。卫生部的作用很小。该部在卫生服务(EVO 资金)中分配国家资金用于临床研究,但并未利用这些资金进行指导。负责卫生服务或国家健康保险的市政府对临床研究几乎没有兴趣。芬兰科学院曾有过促进临床研究的举措,但这些举措并未体现在资金上。临床研究很常见,且具有国际竞争力,但在 21 世纪 00 年代其规模相对下降。工业界是重要的私人资助者,主要资助用于许可目的的药物试验。2002 年至 2010 年间,没有外部赞助商(学术项目)的药物试验有所减少。资金及其针对性、数量均无人负责。对临床研究的关注与其他国家相似,但出现较晚。
我们的研究结果表明,临床研究的治理和资金分散。非系统性的研究环境并没有阻止临床研究的蓬勃发展,但所进行的研究对公共卫生的相关性及其可持续性尚不清楚。