The TARGET study had nearly 20,000 although it was conducted in two sub-studies each of which had slightly fewer than 10,000. (I was a member of the data safety monitoring board.)
See
Farkouh, M. E., et al. (2004), "Comparison of Lumiracoxib with Naproxen and Ibuprofen in the Therapeutic Arthritis Research and Gastrointestinal Event Trial (Target), Cardiovascular Outcomes: Randomised Controlled Trial," Lancet, 364, 675-684.
Schnitzer, T. J., et al. (2004), "Comparison of Lumiracoxib with Naproxen and Ibuprofen in the Therapeutic Arthritis Research and Gastrointestinal Event Trial (Target), Reduction in Ulcer Complications: Randomised Controlled Trial," Lancet, 364, 665-674.
and also
Senn, S. (2008), "Lessons from Tgn1412 and Target: Implications for Observational Studies and Meta-Analysis," Pharm Stat.
It makes a very interesting teaching example - the CONSORT diagram in the Lancet is wrong and there is considerable imbalance between the substudies, which helps make valuable points about randomisation.
Stephen Senn
Professor of Statistics
School of Mathematics and Statistics
Direct line: +44 (0)141 330 5141
Fax: +44 (0)141 330 4814
Private Webpage: http://www.senns.demon.co.uk/home.html
University of Glasgow
15 University Gardens
Glasgow G12 8QW
The University of Glasgow, charity number SC004401
From: Evidence based health (EBH) [mailto:[log in to unmask]] On Behalf Of Neeraj Bhala
Sent: 11 May 2011 16:03
To: [log in to unmask]
Subject: Large-scale randomised trials?
Dear colleagues,
My name is Neeraj ('Nij') Bhala and I am an epidemiologist in Oxford. Mike Clarke (previously of the UK Cochrane Centre and now Director of the All-Ireland Hub for Trials Methodology Research) and I are putting together a list of the large simple randomised trials of healthcare interventions therapies (excluding vaccines and screening) with more than 10,000 participants.
Do any of you have any suggestions for other large randomised trials we might have missed (including their size), people to ask or places to look?
Trials greater than 20,000
Women's Health Initiative
Physicians' Health Study
Women's Health Study
ISIS-3
ISIS-4
GUSTO-1
Chinese Acute Stroke Trial (CAST)
ALLHAT
Heart Protection Study
COMMIT-CCS2
OASIS-5 (MICHELANGELO)
CRASH-2
We look forward to hearing from you.
Kind regards,
Neeraj and Mike
