Registration of noncommercial randomised clinical trials: the feasibility of using trial registries to monitor the number of trials

Trials

Tom Walley¹  Ruairidh Milne²  Alison Price²  Louise Dent²  Lisa Douet²  Eleanor Fairbank²  James Raftery² 

[1] University of Liverpool, Liverpool, UK;University of Southampton, Southampton, UK

关键词: Noncommercial randomised clinical trials;    Trial registration;   

Others  :  1095394
DOI  :  10.1186/1745-6215-13-140

 received in 2011-12-21, accepted in 2012-07-27,  发布年份 2012

【 摘 要 】

Background

A 2003 survey suggested the number of noncommercial trials in the UK was declining. Formation of the NIHR in 2006 and increased research spending by the Department of Health may have increased the number of noncommercial trials but no data are available.

Methods

Available data on UK noncommercial trials (were obtained from the two relevant registries: ISRCTN register for the UK, and US ClinicalTrials.gov. Data on each trial were sorted by start year, and compared with the: 2003 survey, and UKCRN portfolio database from 2007.

Results

The number of UK noncommercial trials registered rose from 25 in 1990 to 188 in 1999, peaked at 533 in 2003, and fell back to 334 in 2009. Total trials registered was similar to but slightly above those in the 2003 survey up to 1998, then rose sharply to 2002 before falling to 2007. From 2007 to 2009 the number registered to start each year was similar to but slightly above the UKCRN database. Less than 10% of UK noncommercial trials registered with ClinGov for most years before 2005, but this rose to 35% by 2009.

Conclusions

For the periods of overlap, trial registration data provide fairly similar totals to other sources on the number of noncommercial trials starting each year. The rise and fall in the number of trials registered between 1999 and 2007 was due to those registered in the ISRCTN database as funded by NHS Trusts. After 2007, the number of trials registered as funded by NHS Trusts has fallen in the ISRCTN register but these trials may have migrated to the US ClinGov register. The total number of noncommercial trial starts, excluding those funded by NHS Trusts, has been upward since around 2002. By 2009 the two main funders were NIHR and charities. Feasibility of using registration data to monitor the number of noncommercial trials has been demonstrated but is complicated by the use of two registers and difficulties in accessing the data. We recommend an annual report on the number of noncommercial trials registering each year.

【 授权许可】

   
2012 Raftery et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

Figure 2.

【 参考文献 】

• [1]Gallan A: Number of clinical trials done in UK fall by two thirds after the EU directive. BMJ 2009, 33:1052.
• [2]Press Release: New Report Examines Obstacles to Non-commercial Clinical Trials. [ http://www.mhra.gov.uk/PrintPreview/PressReleaseSP/CON041316 webcite].
• [3]MHRA Freedom of Information Request. [ www.mhra.gov.uk/home/groups/es-foi/…/foidisclosure/con2031623.pdf webcite].
• [4]Chalmers I, Rounding C, Lock K: Descriptive survey of non-commercial randomised controlled trials in the United Kingdom, 1980–2002. Br Med J 2003, 327:1017-1019.
• [5]UKCRN Portfolio Database. [ http://public.ukcrn.org.uk/search/ webcite]
• [6]Bian ZX, Wu TX: Legislation for trial registration and data transparency. Trials 2010, 11:64. BioMed Central Full Text
• [7]De Angelis CD, Drazen JM, Frizelle FA, Haug C, Hoey J, Horton R, Kotzin S, Laine C, Marusic A, Overbeke AJ, Schroeder TV, Sox HC, Van Der Weyden MB: Is this clinical trial fully registered? A statement from the International Committee of Medical Journal Editors. Ann Intern Med 2005, 143:146-148.
• [8]NHS Research Governance for Health and Social Care: Second Edition. [ http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_4108962 webcite]
• [9]ClinGov. [ http://clinicaltrials.gov/ct2/ webcite]
• [10]Registration of Randomised Clinical Trials and Public Access to Findings. Further Information. London: Department of Health; 2009. [ http://www.controlled-trials.com/ webcite]
• [11]ISRCTN MetaRegister of Current Controlled Trials. [ www.controlled-trials.com webcite]
• [12]National Research Register. [ http://www.nihr.ac.uk/Pages/NRRArchive.aspx webcite]
• [13]House of Commons Health Committee 2004. Evidence by CCT. [ http://www.google.co.uk/#hl=en&cp=36&gs_id=3s&xhr=t&q=CCT+evidence+house+commons+health+committee&pf = p&sclient = psyb&source = hp&pbx = 1&oq = CCT + evidence + house + commons + health + co&aq = 0w&aqi = qw1&aql = &gs_sm = &gs_upl = &bav = on.2,or.r_gc.r_pw.,cf.osb&fp = 15bc013397bd8a17&biw = 1008&bih = 841 webcite]
• [14]Stephen H, Shyama K, Bryony S, Nicholas M: Who Needs What from a National Health Research System: Lessons from Reforms to the English Department of Health’s R&D System. Health Research Policy and Systems 2010, 8:11. BioMed Central Full Text
• [15]Shergold M, Grant J: Freedom and need: the evolution of public strategy for biomedical and health research in England. Health Res Policy Systems 2008, 6:2. BioMed Central Full Text
• [16]Culyer AJ: Funding Research in the NHS. York: University of York; 1994. [Discussion Paper]
• [17]NIHR Annual Report 2009/10 Embedding Health Research. [ http://www.nihr.ac.uk/files/pdfs/400891_NIHR_AnnualReport2010_acc3.pdf webcite]
• [18]Department of Health. 2008/09 NHS R&D Transitional Funding. [ http://www.dh.gov.uk/en/Aboutus/Researchanddevelopment/AtoZ/NationalNHSRDfunding/index.htm webcite]