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At the 2015 REWARD/EQUATOR conference on research waste, the late Doug Altman revealed that his only regret about his 1994 BMJ paper ‘The scandal of poor medical research’ was that he used the word ‘poor’ rather than ‘bad’. But how much research is bad? And what would improve things? We used Cochrane systematic reviews to get an idea of how many trials are bad: we used the Cochrane assessment of trial risk of bias as high as being a proxy for bad.  We were also interested in how many participants were in bad trials and how much these trials cost.  We identified 96 reviews authored by 546 reviewers from 49 clinical Cochrane Review Groups that included 1659 trials done in 84 countries. In summary: most trials are bad.  Only 133 (8%) of the 1640 presenting risk of bias information were low risk of bias.  Most participants were in a bad trial and the money spent on them could, we estimate, fund the UK’s biggest public trial funding programme for at least 10 years. We have five recommendations: trials should be neither funded (1) nor given ethical approval (2) unless they have a statistician and methodologist; trialists should use a risk of bias tool at design (3); more statisticians and methodologists should be trained and supported (4); there should be more funding into applied methodology research and infrastructure (5). In short, most randomised trials are bad and most trial participants will be in one. The research community has tolerated this for decades. This has to stop: we need to put rigour and methodology where it belongs — at the centre of our science.

Ms Stefania Pirosca

Stefania is a Neuroscience student at the University of Aberdeen and worked with Prof. Treweek on two projects: one concerned with the improvements needed for trial design, and one concerned with the ‘scandal of bad research’. Stefania has thoroughly enjoyed her time as a health research intern and as her time at university is coming to an end, she wishes to pursue a PhD in Neuroscience. When she is not studying or working, she enjoys reading fiction, weightlifting and science podcasts.

 Prof Shaun Treweek, Professor, University of Aberdeen

Shaun is a health services researcher interested in efficient trial design, particularly around recruitment and retention and the effective presentation of research evidence.  He also helped to develop PRECIS-2, a tool to match trial design decisions to the information needs of those intended to use the results.  He leads an initiative called Trial Forge (http://www.trialforge.org) that aims to be more systematic about how we identify, generate and use research evidence in making trial design, conduct, analysis and reporting decisions.  In 2019 Trial Forge won the international Cochrane-REWARD Prize for outstanding work in reducing waste in research.  Finally, Shaun is an Editor-in-Chief of the journal Trials.

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A UK wide survey conducted in 2020 suggested there was substantial variation in practice between CTUs when it comes to blinding trial statisticians. The Blinding of Trial Statisticians (BOTS) project was funded by the UK National Institute of Health and Care Research (NIHR) to investigate the reasons for this heterogeneity and to provide guidelines for best practice.

Ensuring statisticians remain blinded to treatment allocation prior to the final analysis reduces the risk that the statisticians could introduce any bias through their conduct and reporting. However, utilising an independent statistician comes with a substantial additional resource cost and can sometimes even lead to potentially suboptimal conduct of the trial.

This webinar will summarise the methodology and findings of the BOTS project. Outputs include a guidance document and risk assessment tool to help CTUs to apply evidence-based decision-making to the blinding of statisticians.

Mais Iflaifel is a clinical Pharmacist with a PhD degree in Pharmacy Practice from Reading University in the UK. Mais has a long experience in higher education teaching and research. Her research focuses on medication safety, insulin use, cardiac medications and best practices. She had 10 papers published in national and international journals.

Christopher Partlett is Assistant Professor of Medical Statistics at Nottingham Clinical Trials Unit in the UK. He has an MSci in Mathematics and PhD in Statistics from the University of Birmingham. He has worked as a Medical Statistician contributing to the design and delivery of randomised trials at multiple UK clinical trials units (CTUs). He also has an interest in trials methodology research and, in particular, the different approaches that CTUs take to randomisation and blinding of trial statisticians.

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Urinary tract infections (UTIs) are among the most common bacterial infections in the outpatient setting. The continued focus on antimicrobial stewardship has driven an increase in the volume of clinical trials investigating various interventions for the treatment of UTIs. The variation of outcomes being reported in these clinical trials, however, makes it difficult to make direct comparisons between the effectiveness of treatment interventions. This webinar will discuss the methods and results of COSUTI, a project that addresses this issue through the development of a Core Outcome Set for interventions to treat uncomplicated UTIs in adults. The project was conducted in collaboration with people who have experienced or cared for someone experiencing a UTI, healthcare practitioners, researchers and policymakers with a strong focus on ensuring the inclusion of stakeholders from countries of different income levels.

Dr Claire Beecher holds Bachelor’s degrees in both Business Studies & Event Management (Limerick Institute of Technology) and Midwifery Science (University of Galway). In 2014 she was awarded the Dr H.H. Stewart Medical Scholarship in Midwifery. Her PhD thesis was titled ‘The development of a survey instrument to evaluate women’s experiences of their maternity care in Ireland’.. The survey instrument developed has been adopted by the National Care Experience Programme as the Irish National Maternity Experience Survey and was implemented nationally in Ireland in February 2020.Claire is postdoctoral researcher on the Priority 3 project, a Priority Setting Partnership to identify and prioritise unanswered questions in the methodology of rapid reviews. Claire is also working on the COS-UTI core outcome set for interventions for the treatment of uncomplicated urinary tract infection in adults with the HRB-TMRN.

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Decentralised clinical trials, which use technological and organisational methods to move clinical trial activities closer to their participants’ homes, have been suggested as a solution to recruitment, retention, and overall trial efficiency challenges. The Innovative Medicines Initiative-funded Trials@Home project is a public-private consortium aiming to promote good practice and adoption of decentralised clinical trial methods in Europe. As part of this project, researchers at the University of Dundee, Scotland, have identified and reviewed completed and in-progress clinical trials that have used decentralised methods to produce initial guidance on decentralised trial conduct. Additionally, interviews with staff, patient representatives, and other stakeholders involved in decentralised clinical trial case studies have supported qualitative research to produce actionable learning from their experiences. This webinar will give an overview of the Trials@Home project and present the systematic review and case study findings.

Dr Amy Rogers is a Clinical Lecturer with MEMO Research at the University of Dundee. Having previously worked as General Practitioner, Amy now researches pragmatic clinical trial methods, focusing on the implementation of decentralised and healthcare-embedded clinical trials. Recent projects have included the ALL-HEART, TIME, and EVIDENCE trials. She is also particularly interested in the role of public engagement and involvement in clinical trials.