Trials is an open access, peer-reviewed, online journal that encompasses all aspects of the performance and findings of randomized controlled trials in health. 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
The reporting of adverse events during clinical trials is generally believed to be poor. An investigation into the reporting of harms in psychological intervention trials funded by the National Institute of Health Research supported this belief and highlighted that reporting criteria for adverse events may be inadequate.
The use of gentamicin to treat Meniere's disease has increased over recent years, though no consensus exists regarding dose regime. This RCT aimed to investigate dose regime, but was prematurely ended due to multiple patients exceeding the accepted amount of hearing loss, one of the primary outcome measures.
Recruitment of young adults for weight gain prevention clinical trials can be challenging. Here, the authors tracked and evaluated the recruitment methods used in the Study of Novel Approaches to Prevention (SNAP) trial to identify which methods held the highest recruitment yield.
Recruiters to randomised trials can be trained to facilitate recruitment by exploring patients' treatment preferences
Barriers to recruitment for RCTs are often caused by a patient’s preference for treatment. This study assessed how recruiters reacted to patient preferences, and observed that recruiters who explored and discussed the reasons behind a patient’s preference facilitated the reconsideration of those who originally declined, promoting more informed decision making.
Informed consent is both an ethical and a legal requirement for trial participation. This study prospectively assessed the deliberation stage of the informed consent decision-making process of potential trial participants from across different clinical areas, highlighting some important considerations for those designing trials.
Latest from the ISRCTN Register
- 29 August 2014
- ISRCTN61977500 - To understand the impact of rifaximin on the NHS hospital resource use associated with the management of patients with hepatic encephalopathy (HE)
- 28 August 2014
- ISRCTN55309164 - Developing and testing the feasibility of an intervention to reduce alcohol consumption in obese men
- 28 August 2014
- ISRCTN70918594 - Effectiveness of short message services reminders on a childhood immunization programme in Kadoma, Zimbabwe
- 27 August 2014
- ISRCTN10316077 - An initial study of an online self-help programme for individuals seeking employment
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).