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

Health Research Policy and Systems

Elena Regushevskaya²  Piret Veerus⁴  Jorma Virtanen¹  Elina Hemminki³ 

[1]University of Oulu, Faculty of Medicine, P.O. Box 5281, Oulu 90014, Finland

[2]National Institute for Health and Welfare, P.O. Box 30, Helsinki 00271, Finland

[3]Hjelt Institute/Department of Public Health, University of Helsinki, P.O. Box 41, Helsinki 00014, Finland

[4]National Institute for Health Development, Hiiu 42, Tallinn 11619, Estonia

关键词: Sponsoring;    Finland;    Drug trials;    Clinical research;   

Others  :  809791
DOI  :  10.1186/1478-4505-11-17

 received in 2013-02-22, accepted in 2013-04-30,  发布年份 2013

【 摘 要 】

Background

Regardless of worries over clinical research and various initiatives to overcome problems, few quantitative data on the numbers and type of clinical research exist. This article aims to describe the volume and type of clinical research in 2002 and 2007 in Finland.

Methods

The research law in Finland requires all medical research to be submitted to regional ethics committees (RECs). Data from all new projects in 2002 and 2007 were collected from REC files and the characteristics of clinical projects (76% of all submissions) were analyzed.

Results

The number of clinical projects was large, but declining: 794 in 2002 and 762 in 2007. Drug research (mainly trials) represented 29% and 34% of the clinical projects; their total number had not declined, but those without a commercial sponsor had. The number of different principal investigators was large (630 and 581). Most projects were observational, while an experimental design was used in 43% of projects. Multi-center studies were common. In half of the projects, the main funder was health care or was done as unpaid work; 31% had industry funding as the main source. There was a clear difference in the type of research by sponsorship. Industry-funded research was largely drug research, international multi-center studies, with randomized controlled or other experimental design. The findings for the two years were similar, but a university hospital as the main research site became less common between 2002 and 2007.

Conclusions

Clinical research projects were common, but numbers are declining; research was largely funded by health care, with many physicians involved. Drug trials were a minority, even though most research promotion efforts and regulation concerns them.

【 授权许可】

   
2013 Hemminki et al.; licensee BioMed Central Ltd.

【 参考文献 】

• [1]IOM (Institute of Medicine): Transforming Clinical Research in the United States: Challenges and Opportunities: Workshop Summary. Washington DC: The National Academies Press; 2010.
• [2]IOM (Institute of Medicine): Public Engagement and Clinical Trials: New Models and Disruptive Technologies: Workshop Summary. Washington DC: The National Academies Press; 2011.
• [3]New Pathway for the Regulation and Governance of Health Research. London: The Academy of Medical Sciences; 2011.
• [4]Kramer JM, Smith PB, Califf RM: Impediments to clinical research in the United States. Clin Pharm Ther 2012, 91:535-541.
• [5]Gotzsche PC: Why we need easy access to all data from clinical trials and how to accomplish it. Trials 2011, 12:249. BioMed Central Full Text
• [6]European Science Foundation: Investigator-Driven Clinical Trials. Setting Science Agendas for Europe. Strasbourg: ESF Report; 2009.
• [7]European Science Foundation: ESF-EMRC Position Paper: Proposal for a Revision of the “Clinical Trials Directive” (2001/20/EC) and Other Recommendations to Facilitate Clinical Trials. ESF: Strasbourg; 2011.
• [8]Swan J, Robertson M, Evans S: Managing Clinical Research in the UK. Warwick: Warwick Business School; 2009.
• [9]Gestrelius S: Nordic Cooperation in Clinical Research – Opportunities and Challenges. Nordic Forum for Innovation in Health Care and Medicine. 2009. http://www.regjeringen.no/pages/16778530/200900715_D1_V10.pdf webcite
• [10]Patsopoulos NA, Ioannidis JPA, Analatos AA: Origin and funding of most frequently cited papers in medicine: database analysis. BMJ 2006, 332(7549):1061-1064.
• [11]Hemminki E, Piret V, Virtanen J, Juhani L: A qualitative study on clinical research in Finland - fragmented governance and volume in the 2000s. BMJ Open 2013, 3:2.
• [12]Viljamaa K, Lehenkari J, Lemola T, Tuominen T: Tutkimuspolitiikan välineet ja käytännöt – viiden maan vertailu. Suomen Akatemian julkaisuja 2/10. Suomen Akatemia: Helsinki; 2010.
• [13]CCMO: Research Involving Human Subjects 2006–2010. Annual Report 2010. http://www.ccmo-online.nl/main.asp?pid=2&sid=5 webcite
• [14]Califf RM, Zarin DA, Kramer JM, Sherman RE, Aberle LH, Tasneem A: Characteristics of clinical trials registered in ClinicalTrials.gov, 2007–2010. JAMA 2012, 307(17):1838-1847.
• [15]Academy of Finland: Clinical Research in Finland and Sweden. Helsinki: Publications of the Academy of Finland; 2009.
• [16]Hemminki A, Kellokumpu-Lehtinen PL: Harmful impact of EU clinical trials directive. BMJ 2006, 332:501-502.
• [17]Clinical trials statistics. http://www.fimea.fi/instancedata/prime_product_julkaisu/fimea/embeds/fimeawwwstructure/19618_kliinisten_laaketutkimusten_tilasto_2010.pdf webcite
• [18]Hartmann M: Impact assessment of the European Clinical Trials Directive: a longitudinal, prospective, observational study analyzing patterns and trends in clinical drug trial applications submitted since 2001 to regulatory agencies in six EU countries. Trials 2012, 13:53. BioMed Central Full Text
• [19]Lundh A, Sismondo S, Lexchin J, Busuioc OA, Bero L: Industry sponsorship and research outcome (review). Cochrane Database Syst Rev 2012., 12
• [20]Lexchin JR: Implications of pharmaceutical funding on clinical research. Ann Pharmacother 2005, 39(1):194-197.
• [21]Avorn J: Torcetrapid and atrovastin – should marketing drive the research agenda? NJEM 2005, 352:2574-2576.
• [22]Den Boer A, Jansen C: Expert Meeting on Publicly Funded Clinical Trials, 22–23 November 2010. Amsterdam: Wemos Foundation; 2011.
• [23]Light DW, Lexchin J: Will lower drug prices jeopardize drug research? A policy fact sheet. Am J Bioeth 2004, 4:W1-W4.
• [24]Berendt L, Hakansson C, Bach KF, Dalhoff K, Andreasen PB, Petersen LG, Andersen E, Poulsen HE: Effect of European clinical trials directive on academic drug trial in Denmark: retrospective study of applications to the Danish medicines agency 1993–2006. BMJ 2008, 336:33-35.
• [25]EFGCP European Forum for Good Clinical Practice: Impact of Clinical Research of European Legislation. 2009. Final report of ICREL to European Commission, Directorate Research. http://www.myesr.org/html/img/pool/Final_report_ICREL.pdf webcite
• [26]Apperely J: Has the European clinical trials directive been a success? BMJ 2010, 340:937-938.