International Clinical Trials Day 2011
20 May 2011 was the seventh International Clinical Trials Day, celebrating how the clinical trial can improve health and well-being around the world and helping to raise awareness of the importance of research to health care. The Cochrane Collaboration has worked with members of the UK Medical Research Council's Network of Hubs for Trials Methodology Research and others to prepare a new collection of podcasts to mark the event.
The Day highlights how partnerships between patients and practitioners are vital to high-quality, relevant research. Among the special events organised by the European Clinical Research Infrastructures Network (ECRIN) was a series of public lectures and discussions in Palais Harrach in Vienna, Austria, introduced by Christian Gluud from the Cochrane Hepatobiliary Review Group. In a podcast, Christian describes the importance of International Clinical Trials Day.
International Clinical Trials Day
Network of Hubs for Trials Methodology Research
Over the last three years, the UK's Medical Research Council has established a network of eight hubs for trials methodology research across the UK. These will conduct research, and will provide training and support for people planning, conducting and reporting trials. Emily Crowe is the Network co-ordinator and describes the role of the Network in a podcast.
Hubs for Trials Methodology Research
Mega-trials
One of the hubs is based at the Clinical Trials Service Unit (CTSU) in the University of Oxford in England. CTSU is home to some of the largest treatment trials, each of which randomised more than 20,000 individuals. In his podcast, Neeraj Bhala from CTSU talks about these 'mega-trials', including ISIS-3[1] and ISIS-4,[2] GUSTO,[3] the Chinese Acute Stroke Trial,[4] and the CRASH-2 trial,[5] which was featured in a Cochrane Review[6] and evidence pod and Cochrane Journal Club earlier this year.
Antifibrinolytic drugs for acute traumatic injury
Antifibrinolytic drugs for acute traumatic injury
Antifibrinolytic drugs for acute traumatic injury
Inconsistencies between protocols, trial registries and reports of trials
Earlier this year, a Cochrane methodology review led by Kerry Dwan from the MRC North West Hub for Trial Methodology Research examined several studies that showed how the initial information about a trial, as recorded in its protocol or entry in a trials registry, is not always reflected in the methods described when the trial's findings are reported.[7] Kerry discusses the review and its implications.
Changes between protocols and reports
Comparison of protocols and registry entries to published reports for randomised controlled trials
Clinical trials of traditional medicines and plants
The Multi-disciplinary University Traditional Health Initiative (MUTHI) is a new international consortium with the aim of increasing the capacity of African clinical and public health researchers to conduct trials of traditional medicines. Quinton Johnson, Director of the South African Herbal Science and Medicine Institute at the University of the Western Cape, outlines the work of MUTHI and its plans to facilitate the assessment of the medicinal properties of plants.
Trials of traditional medicines and plants
Evidence Aid and clinical trials in disaster settings
Evidence Aid was established by The Cochrane Collaboration to improve access to systematic reviews of relevance to natural disasters and other humanitarian emergencies.[8][9] It is helping to identify the need for clinical trials to resolve the many uncertainties that face people making decisions about interventions in such settings. Mike Clarke, from the All-Ireland Hub for Trials Methodology Research, based at Queen's University in Belfast, Northern Ireland, and one of the founders of Evidence Aid, highlights some of the trials that have been done.
Bioethics in disaster settings
The ethical challenges for trials in disaster settings is taken up in the podcast from Dónal O'Mathúna, who has initiated work into the bioethics of disasters research with his colleagues at Dublin City University in Ireland and elsewhere.[10] In April 2011, he co-organised a symposium at the Brocher Foundation in Switzerland to discuss these issues, and the presentations will be available on DisasterBioethics.com, with an edited volume to be published in 2012.
References
1. ISIS-3 (Third International Study of Infarct Survival) Collaborative Group. ISIS-3: a randomised comparison of streptokinase vs tissue plasminogen activator vs anistreplase and of aspirin plus heparin vs aspirin alone among 41,299 cases of suspected acute myocardial infarction. Lancet 1992;339:753–70. Abstract
2. ISIS-4 (Fourth International Study of Infarct Survival) Collaborative Group. ISIS-4: a randomised factorial trial assessing early oral captopril, oral mononitrate, and intravenous magnesium sulphate in 58,050 patients with suspected acute myocardial infarction. Lancet 1995;345:669–85. Abstract
3. The GUSTO investigators. An international randomized trial comparing four thrombolytic strategies for acute myocardial infarction. New England Journal of Medicine 1993;329:673–82. Full text
4. CAST (Chinese Acute Stroke Trial) Collaborative Group. CAST: randomised placebo-controlled trial of early aspirin use in 20,000 patients with acute ischaemic stroke. Lancet 1997;349:1641–9. Abstract
5. CRASH-2 trial collaborators, Shakur H, Roberts I, Bautista R, Caballero J, Coats T, et al. Effects of tranexamic acid on death, vascular occlusive events, and blood transfusion in trauma patients with significant haemorrhage (CRASH-2): a randomised, placebo-controlled trial. Lancet 2010;376:23–32. Abstract
6. Roberts I, Shakur H, Ker K, Coats T, on behalf of the CRASH-2 Trial collaborators. Antifibrinolytic drugs for acute traumatic injury. Cochrane Database of Systematic Reviews 2011, Issue 1. Art. No.: CD004896. Abstract
7. Dwan K, Altman DG, Cresswell L, Blundell M, Gamble CL, Williamson PR. Comparison of protocols and registry entries to published reports for randomised controlled trials. Cochrane Database of Systematic Reviews 2011, Issue 1. Art. No.: MR000031. Abstract
8. Tharyan P, Clarke M, Green S. How the Cochrane Collaboration is responding to the Asian tsunami. PLoS Medicine 2005;2:e169. Full text
9. Clarke M. Evidence Aid – from the Asian tsunami to the Wenchuan earthquake. Journal of Evidence-based Medicine 2008;1:9–11. Abstract
10. O'Mathúna DP. Conducting research in the aftermath of disasters: ethical considerations. Journal of Evidence-based Medicine 2010;3:65–75. Abstract
Image credit: David Aubrey/Science Photo Library, M625/1285
Date published: 19 May 2011 (updated 23 May 2011)
Contact: Cochrane Editorial Unit (editorial-unit@cochrane.org)
