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
Neonatal hypoxemic respiratory failure is generally associated with widespread vasoconstriction of the pulmonary microvasculature. Two pilot RCTs were conducted to assess the safety and feasibility of using aerosolized prostaglandins E1 (PGE1) as a selective pulmonary vasodilator, which highlighted the need for pragmatic study designs.
Comparison of anticipated and actual control group outcomes in randomised trials in paediatric oncology
Historically controlled studies are often conducted in paediatric oncology. However, control groups in RCTs were observed to perform better than anticipated, indicating that historically controlled studies using similar assumptions for the control group were likely to overestimate benefits of new treatments.
First postulated in 2011, the ‘unpredictability paradox’ states that randomised and non-randomised studies differ in an unpredictable direction. The authors discuss problems that arise from this inference and conclude further justification is required in regards to the unpredictability paradox.
Radioembolisation with yttrium-90 microspheres versus sorafenib for treatment of advanced hepatocellular carcinoma
Untreated advanced hepatocellular carcinoma is linked to poor prognosis. The SARAH trial will compare the current recommended treatment, sorafenib, against radiation therapy with yttrium-90 microspheres, which has shown efficacy in cohort studies, in patients with advanced hepatocellular carcinoma.
It is often considered inappropriate for patients to enrol in multiple ongoing trials due to ethical, safety, statistical, and practical reasons. These aspects are discussed and the authors propose that co-enrolment can be managed, which would increase opportunities for research-led improvements in clinical practice.
Trials 2014, 15:486
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).