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Researchers working on randomised trials would probably describe this as an exciting and challenging time for trials. The costs and regulations associated with trials are increasing, and as they become more expensive and complex, some researchers are moving away from them to other types of study to evaluate the effects of healthcare interventions. However, the biases inherent in such non-randomised trials hinder their ability to produce the estimates that are needed to make well-informed choices about interventions, actions and strategies. These choices often require data on cost effectiveness and as the pressure on the resources available for health care grow around the world, there is increasing demand for reliable and robust estimates of the effects of health care, so that people can make well informed choices. Alongside this, the number and variety of treatments continues to grow, increasing pressures on researchers to find out if these are useful alternatives to current treatments. This background means that high quality research to make sure that the right trials are done, in the right ways and reported fairly and clearly is now needed more than ever.

One of the ways to help achieve this will be through research into research, as highlighted in recent issues of the Journal.[1] This research needs to be seen in the context of other similar studies and an important means of achieving this is through systematic reviews of methodology research. A major source of these reviews is the Cochrane Methodology Review Group. Unlike other Cochrane Reviews Group which focus on reviews of the effects of healthcare interventions or diagnostic test accuracy, the Methodology Review Group brings together the evidence on issues relating to randomized trials, systematic reviews and other studies of health and social care.

Cochrane Methodology Reviews apply the systematic review approach to the assessment of methodology relevant to these evaluations. They include reviews of the effects of interventions or actions and reviews that are more descriptive. Some of the most popular Cochrane Methodology Reviews are those looking at the effects of different recruitment strategies for randomized trials[2] and ways to improve the response rates for postal questionnaires.[3] There are also reviews of different ways to conduct systematic reviews, such as electronic versus hand searching in systematic reviews[4] and the value of checking the references lists of included studies.[5]

Cochrane Methodology Reviews that explore the prevalence of problems in research include those looking at the impact of publication bias[6] and changes between the protocol for a trial and its subsequent publication.[7] While among the more descriptive reviews, Ben Djulbegovic and colleagues recently showed that new treatments are, on average, only slightly better than established trials when tested in randomised trials.[8]

This section was prepared as part of the work of the All-Ireland Hub for Trials Methodology Research and the TENALEA project. The TENALEA project provides an online system for the registration and randomisation of participants into research studies in health care. It has been developed by the National Cancer Institute in Amsterdam in The Netherlands, working with partners in some of the largest cancer research groups in Europe and is now being deployed, with funding from the European Union (contract C029334). More information, including details of how to use the system, is available at http://www.tenalea.com. Further information on the All-Ireland Hub for Trials Methodology Research and the MRC Network of Hubs is available from. http://www.qub.ac.uk/research-centres/CentreforPublicHealth/Research/TheAll-IrelandHubforTrialsMethodologyResearch/.

  • 1
    Anon. Education section – Studies within a trial (SWAT). Journal of Evidence Based Medicine 2012; 5(1): 445.
  • 2
    Treweek S, Mitchell E, Pitkethly M, Cook J, Kjeldstrøm M, Johansen M, Taskila TK, Sullivan F, Wilson S, Jackson C, Jones R, Lockhart P. Strategies to improve recruitment to randomised controlled trials. Cochrane Database of Systematic Reviews 2010, Issue 4. Art. No.: MR000013.
  • 3
    Edwards PJ, Roberts I, Clarke MJ, DiGuiseppi C, Wentz R, Kwan I, Cooper R, Felix LM, Pratap S. Methods to increase response to postal and electronic questionnaires. Cochrane Database of Systematic Reviews 2009, Issue 3. Art. No.: MR000008.
  • 4
    Hopewell S, Clarke MJ, Lefebvre C, Scherer RW. Handsearching versus electronic searching to identify reports of randomized trials. Cochrane Database of Systematic Reviews 2007, Issue 2. Art. No.: MR000001.
  • 5
    Horsley T, Dingwall O, Sampson M. Checking reference lists to find additional studies for systematic reviews. Cochrane Database of Systematic Reviews 2011, Issue 8. Art. No.: MR000026.
  • 6
    Hopewell S, Loudon K, Clarke MJ, Oxman AD, Dickersin K. Publication bias in clinical trials due to statistical significance or direction of trial results. Cochrane Database of Systematic Reviews 2009, Issue 1. Art. No.: MR000006.
  • 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.
  • 8
    Djulbegovic B, Kumar A, Glasziou PP, Perera R, Reljic T, Dent L, Raftery J, Johansen M, Di Tanna GL, Miladinovic B, Soares HP, Vist GE, Chalmers I. New treatments compared to established treatments in randomized trials. Cochrane Database of Systematic Reviews 2012, Issue 10. Art. No.: MR000024.