Current Controlled Trials Ltd - 2003 Report for Advisory Board
http://www.controlled-trials.com/
January 2004

Introduction

Since its creation in 1998, Current Controlled Trials Ltd (CCT) has remained committed to its guiding principle of providing free and open access to information about ongoing randomised controlled trials. Following the unsuccessful funding bid to the European Union, CCT introduced charges in late 2002/early 2003 to contribute to the cost of hosting trial information in the metaRegister of Controlled Trials (http://www.controlled-trials.com/mrct/) and of assigning a registration number via the International Standard Randomised Controlled Trial Number scheme (http://www.controlled-trials.com/isrctn/). 

CCT has looked to trial sponsors and registers holders to support the effort to provide trial information free to users. The request for such a contribution has been well accepted in general. An ongoing survey of our site users shows that:

• The majority of users are in academia, industry or the health professions
• The balance of interest in the metaRegister and ISRCTN Register is in proportion to their current sizes
• When disease areas of particular interest are specified, cancer is top of the list
• Users comment favourably on the overall usefulness of the site
• As of January 2004, there are over 22,000 registered site users, a 25% increase on the 17,500 users registered in January 2003.

What happened in 2003?

• Gerd Antes, Director of the German Cochrane Centre (http://www.cochrane.de/) took over from Iain Chalmers as the new chair of the Advisory Board in July 2003. He has been actively promoting the ISRCTN cause in Germany and has been instrumental in securing the support of the Cochrane Haematological Malignancies Group (CHMG) in Cologne, a specialised group of researchers and consumer representatives that belong to the Cochrane Collaboration (http://www.chmg.de/html/relatedtopics.htm).
• Other organisations that have committed to support the ISRCTN scheme include:
• The European Science Foundation (ESF) who have renewed their recommendation that all member organisations make trial registration a condition of funding, provide a core dataset to the metaRegister and support the development and use of the ISRCTN in their 2003 communiqué http://www.esf.org/esf_genericpage.php?language=0&section=2&domain=2&genericpage=1867.
• The Canadian Institutes of Health Research (http://www.cihr-irsc.gc.ca/e/193.shtml) who are planning to assign ISRCTNs to over 100 trials in 2004.
• The Australian National Health and Medical Research Council (NHMRC) who have included a reference to the ISRCTN scheme on their website under their Project Grant Funding Policy Document (<http://www.nhmrc.gov.au/funding/advice.htm>)
• The Vancouver Group (http://www.icmje.org/) who are responsible for the Uniform Requirements for Manuscripts Submitted to Biomedical Journals have agreed to discuss the ISRCTN scheme at the committee's next meeting in June 2004.

• After a successful pilot by the UK Medical Research Council and the UK Co-ordinating Committee for Cancer Research, the ISRCTN register was officially launched in May 2003. One of the key improvements is the availability of an online ISRCTN application form on http://www.controlled-trials.com/isrctn/submission/. The number of ISRCTNs has more than doubled since January 2003 and reached 1,370 in January 2004.

• In September 2003, as part of a 3 year contract with the Department of Health, CCT launched the NHS Trust Clinical Trials (NHSTCT) Register containing over 500 trials sourced from the NHS National Research Register (http://www.update-software.com/National/) and wholly funded by the NHS in England. The register is designed to complete the picture of randomised controlled trials being undertaken in England by adding to the three other NHS trial registers (the national, regional, and health technology assessment programmes). Scotland, Wales and Northern Ireland have been asked to consider building similar registers.
• CCT was actively involved with the National Cancer Research Institute (NCRI - http://www.cancertrials.org.uk/index.html) in their effort to set up a UK Cancer Trials Register and also collaborated with the NHS National electronic Library of Health (http://www.nelh.nhs.uk/) on a joint paper regarding the need for a UK register of all randomised controlled trials. Funding has not yet been confirmed for these initiatives.
• There has been increased synergy with CCT’s sister publishing company BioMed Central, making sure that visitors to BioMed Central journals can also search CCT trials and that authors publishing a protocol or the results of a trial do not pay the ISRCTN fee if they belong to the BioMed Central institutional scheme (see for example http://breast-cancer-research.com/info/authors/instructions/#h1general)

What is planned for 2004?

• There will be a push to give more international support to the ISRCTN scheme. Following a meeting with the World Health Organisation, Medical Research Council and The Lancet in December 2003, there is hope that the WHO may be interested to become an active supporter of the ISRCTN scheme. The WHO is currently reviewing the possibility of registering about 200 of their own trials but they have not yet decided their preferred registration option.
• CCT will also aim to maintain close contacts with the other key international trial registration schemes (such as EUDRACT in Europe and www.ClinicalTrials.gov in the USA) and discussions have started in that direction.
• CCT will endeavour to promote the ISRCTN scheme in countries which are supporting trial registration such as:
• Germany, in which a new funding scheme for clinical trials was introduced in November 2003 by the German Federal Ministry of Education and Research (http://www.bmbf.de/en/index.php3) and the German Research Foundation (http://www.dfg.de/en) - the scheme makes it compulsory to register a trial with an ISRCTN
• The Netherlands, which are planning to set up a national trials register at the Dutch Cochrane Centre (http://www.cochrane.nl/)

• Technical improvements will continue on the CCT website in order to implement better search facilities and facilitate payment for registration services.

• The ISRCTN fee has been increased to £80/€116/US$128 to cover increased internal costs for running the scheme.

For further details, please contact info@controlled-trials.com