Trials is an open access, peer-reviewed, online journal that encompasses all aspects of the performance and findings of randomized controlled trials. We publish articles on general trial methodology as well as protocols, commentaries and traditional results papers - regardless of outcome or significance of findings.
- Doug Altman, University of Oxford
- Curt Furberg, Wake Forest University of Medicine
- Jeremy Grimshaw, Ottawa Health Research Institute
Predicting the potential success of an ongoing clinical trial can be of interest to many different bodies. This study uses the National Surgical Adjuvant Breast and Bowel trial C-08 to illustrate a methodology for incorporating publicly available results from interim analyses to assess the probability the trial will be successful.
The development of approaches to prevent HIV infection have increased in recent years, with many generic candidates now in early clinical development stages. To accelerate the early development of HIV vaccine strategies this study designed a randomised multi-arm phase I/II trial for assessing both safety and immunogenicity.
The potential importance of community engagement during biomedical research conducted in resource poor settings is becoming increasing recognised, leading to the authors of this study assessing and discussing their experiences of formal community engagement during a paediatric malaria vaccine RCT conducted in Kenya.
Patient information leaflets (PILs) for UK RCTs: Do they support informed decision making in trial participation?
Informed consent from participants of clinical trials is the foundation of ethical healthcare research. Unfortunately, as this feasibility study demonstrates, PILs given to potential participants may not meet current standards to support a well-informed decision, and hence the authors suggest an evaluation tool to assess the quality of PILs.
Obesity leads to many adverse effects on health and preventative measures have been shown to be most effective early in life. The use of ‘Health Promoting Agents’ in a school-based programme was consequently assessed and concluded to have a positive impact on reducing obesity prevalence in boys.
Latest from the ISRCTN Register
- 10 March 2014
- ISRCTN27961345 - A study to look at the safety and performance of Neuromuscular Electrical Stimulation (NMES) with the NeuroTech Vital device compared to the itouch Sure Pelvic Floor Exerciser for the treatment of stress urinary incontinence
- 10 March 2014
- ISRCTN31383218 - The Hull and East Yorkshire Angioplasty (HEYA): A study investigating the effects of balloon inflation time on patient quality of life outcomes and long term arterial patency in the superficial femoral and popliteal arteries
- 07 March 2014
- ISRCTN24593488 - Pomalidomide Specific Targeting in Relapsed and Refractory Myeloma (MUK Seven)
- 07 March 2014
- ISRCTN80682973 - A medical trial looking at ways to improve the quality and delivery of care for patients having emergency abdominal surgery
Trials 2014, 15:73
Trials supports the AllTrials initiative, campaigning for the registration of all trials past and present, and the reporting of full methods and the results of all trials.
Restoring invisible and abandoned trials: a call for people to publish the findings published in the BMJ in June 2013, calling for wider publication of stopped and unfinished trials.
Professor Doug Altman graduated in statistics from the University of Bath and has worked for the Medical Research Council as a statistical consultant in a wide variety of medical areas. In 1988 he became head of the newly formed Medical Statistics Laboratory (now Medical Statistics Group) at ICRF (now Cancer Research UK), and in 1995 also became founding director of the Centre for Statistics in Medicine (CSM) in Oxford. In 1997, Professor Altman received the Bradford Hill Medal for his contributions to medical statistics and a DSc from the University of London and, in 1998 was made Professor of Statistics in Medicine by the University of Oxford. His varied research interests include the use and abuse of statistics in medical research, studies of prognosis, regression modelling, systematic reviews and meta-analysis, randomised trials, and studies of medical measurement.
Curt D. Furberg
Professor Curt D. Furberg is a co-Editor-in-Chief of Trials. He is a Professor of Public Health at Wake Forest University Health Sciences, where he has been since 1986. Professor Furberg earned his MD in Sweden in 1963 and has worked at the Minneapolis LRC Clinic as the Chief of the Clinical Trials Branch and the Clinical Trials Research Branch of the National Heart, Lung, and Blood Institute - where he was the Associate Director for the Clinical Applications and Prevention Program. In addition, Professor Furberg is a nationally and internationally recognized expert on the design, conduct, analysis and monitoring of clinical trials. He has worked closely with investigators at the NIH and several pharmaceutical companies and is also a world-renowned cardiovascular epidemiologist with special expertise in lipid-lowering and blood pressure-lowering therapies. He is a strong proponent for evidence-based medicine, and his public health background provides a strong foundation for his views on drug evaluation and patient safety.
Professor Jeremy Grimshaw is the Director of the Clinical Epidemiology Program at the Ottawa Health Research Institute and the Director of the Center for Best Practice at the University of Ottawa. He holds a Tier 1 Canadian Research Chair in health knowledge transfer and uptake and was made a Professor of Medicine by the University of Ottawa. Prior to this, he held a Personal Chair in health services research at the University of Aberdeen and was the Program Director of the Effective Professional Program within health services research, one of the largest implementation research programs within the UK. Professor Grimshaw’s research interests are in knowledge translation,quality improvement,complex interventions. systematic reviews, cluster randomized trials, quasi experimental studies and behavioural theories (and their application to professional behaviour).
Reviewer acknowledgements 2013
Published: 26 February 2014
Last updated: 10 March 2014
Study protocols of trials in the Tailored Implementation for Chronic Diseases (TICD) project
Published: 5 December 2013
Last updated: 9 January 2014
Volume 14 Suppl 1 (29 November 2013)
Edinburgh, UK. 18-19 November 2013