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Trials Research and Methodologies Unit- TRAMS

Contact: Dr. Frances Shiely

Senior Lecturer, Director MSc Clinical Trials, HRB TMRN PI UCC

TRAMS places trial methodological research at the heart of clinical trials.  Our aim is to build capacity in trial methodology for the improvement of clinical trial efficiency, with the ultimate goal of delivering better treatments and improving quality of life and health outcomes in patients. TRAMS maps directly to the CRF-C vision and the strategic goals of the College of Medicine and Health, UCC and the HRB.

Dr. Frances Shiely is the Director of TRAMS. If you wish to get involved in methodological research within your own discipline, contact Frances at f.shiely@ucc.ie.  Methodological research is feasible within all study types, not just clinical trials, e.g., cohort studies, case-control studies, and cross-sectional studies. Funders welcome methodological research embedded in larger research proposals.  The purpose of methodological research is to improve our processes and hence make our research more efficient, leading to less research waste and better patient outcomes.

Prof. Joe Eustace 

Name: Prof. Joe Eustace

Biography: Prof. Joe Eustace is the Director of the HRB Clinical Research Facility at UCC (CRF-C), Chairman of the HRB CRCI Senior Management Team and Professor of Patient Focused Research at UCC. The CRF-C facility is co-funded by the University and by the Health Research Board and supports the design, conduct and analysis of Patient Focused Research throughout UCC and its affiliated Medical Centres. He is also a Consultant Renal Physician at Cork University Hospital.

Niamh O’Shea, HRB TMRN PhD

Name: Niamh O’Shea

Education: MSc in Healthcare Ethics and Law

Biography: Niamh O’Shea began working on her PhD scholarship with UCC and the Health Research Board – Trial Methodology Network (HRB-TMRN) in early 2019. Prior to that Niamh worked as a Research Support Officer at the HRB Clinical Research Facility Cork, where she was the Project Manager of a pilot study

From 2010 to 2017 Niamh was based at the INFANT Centre, University College Cork, where she was the Clinical Trial Coordinator for a double blind, international, multicentre EU FP7 funded project in conjunction with being the Project Manager of various Neonatal Clinical Trials, Medical Device Trials and Observational Studies.

Niamh was previously employed as the Project Manager for an independent, single-centre CRO which performed Phase I bioequivalence and bioavailability clinical trials, dental and cosmetic studies. Niamh has been working within the research industry for 12 years.

Kirsty Loudon

Name: Kirsty Loudon

Education: DPhil University of Dundee – PRECIS-2 “Making trials matter: providing an empirical basis for the selection of pragmatic design choices in clinical trials”, MPH (Emory) Environmental and Occupational Health, BN/RGN (University of Glasgow)

Biography: Interested in developing PRECIS-3 following increasing interest in the PRECIS-2 tool, an online trial design tool – registration site (http://www.PRECIS-2.org/). Previously employed by Springer Nature Trials journal as a SPIRIT protocol editor and lecturer at Stirling University teaching undergraduate nurses.

Current Project: To systematically collate all published ideas from a citation review of Web of Science to inform the development of PRECIS-3 working with Professor Zwarenstein and Alison Howie in Toronto, with an international steering group including Frances Shiely. Also, assist with update of the Cochrane methodology review – Publication Bias review incorporating the time-lag bias review lead by Marian Showell, Cochrane NZ.

Aoife O’Keeffe, HRB TMRN Summer Student Scholarship

Name: Aoife O’Keeffe

Education: Fourth year BSc Public Health Sciences

Biography: BSc Public Health Sciences Student Aoife O’Keeffe has been awarded a HRB TMRN Summer Student Scholarship. Aoife is from Blackrock, Cork and is eagerly looking forward to working on trials methodological research.

Current Project: The project is titled, “Trial managers: an undervalued resource in the clinical trials team?”. The purpose of the study is to ascertain the current training level of clinical trial managers, their approaches to clinical trial management and in their view, the important factors that successfully deliver a clinical trial. For more information, contact Dr. Frances Shiely at f.shiely@ucc.ie

 

Ellen Murphy, Research Assistant

Name: Ellen Murphy

Education: BSc Public Health (First Class Honours) from University College Cork.

Biography: : Ellen Murphy graduated with a BSc (First Class Honours) in Public Health from University College Cork in 2020. She was previously awarded a HRB TMRN Summer Scholarship, 2019, which started her interest in clinical trial methodology research. She is currently a Research Assistant at the HRB Clinical Research Facility. She works with Dr. Frances Shiely. In September Ellen will be starting a PhD on trial methodology. She will focus on communication in clinical trials across the lifecycle. Ellen was recently awarded her first grant as a co-applicant to the UCC LTA Enhancement Fund. The project is entitled “How to read and grade a research paper and the evidence for why”.

Current Project: Ellen is currently working on a costing project, costing the top ten most routinely used participant retention strategies for RCTs in the United Kingdom. She is also working as a collaborator on the Health Research Board Trials Methodology Research Network EXCELSIOR project (EXploring the ComplExity and Language of ConsSent and participation InfOrmation in Randomised Controlled Trials).  As well as this Ellen works on two SWAT projects; “Effects of a multi-trial programmable animation platform on the efficiency and success of pre-screening and subsequent recruitment to a randomised trial” and “Does patients’ guided self-reflection on their illness increase engagement with and recruitment to clinical trials: a mixed-methods study within a trial (SWAT)”.

Danielle Murphy, HRB Summer Student Scholarship 2021

Name: Danielle Murphy

Education: Second year Medical and Health Science, UCC.

Biography: Danielle is from Innishannon, Co. Cork. Conducting group projects is a fundamental element of her University course, which she thoroughly enjoys. Danielle hopes that this experience will prove invaluable as she embarks on her research work. Danielle was awarded a HRB TMRN Summer Student Scholarship in 2020 for a study titled ‘Involving the research nurse in the design phase of clinical trials: should it be compulsory? She is preparing this manuscript for publication.

Current Project: EXCELSIOR project (EXploring the ComplExity and Language of ConsSent and participation InfOrmation in Randomised Controlled Trials).

Genevieve Shiely Hayes

Name: Genevieve Shiely Hayes

Education: Coláiste na Toirbhirte, Bandon, Co. Cork.

Biography: Genevieve is a fifth year student at Coláiste na Toirbhirte, Bandon, with an interest in medical and health sciences.

Current Project: EXCELSIOR Project(EXploring the ComplExity and Language of ConsSent and participation InfOrmation in Randomised Controlled Trials). EXCELSIOR will compile a research repository of Participation Information Leaflets (PILs) and Informed Consent Forms (ICFs) used in RCTs. This repository will be publicly available for research purposes. It will use the collated participant information and ICFs to help the study, together with patients and the public, to understand the language and complexity of the information provided to potential trial participants in Ireland and the UK. Genevieve is working on data extraction for her internship.

Dylan Bearman

Name: Dylan Bearman

Education: Second-year student from C.I.T. studying for BSc Software Development.

Biography: Dylan is from Crossbarry, County Cork. Dylan has a keen interest in everything computer related. He hopes this experience will serve him well as he progresses in his carrier.

Current Project: Dylan will work on a number of projects including: CRF-C website; Nephrology registry using RedCap; interfacing between R and CASTOR.  Dylan will be working with the CRF-C Instructional Designer Vincent Russell and Associate Statistician Dr Brendan Palmer.

 

Kerrie Lousie Gallagher

Name: Kerrie Lousie Gallagher

Education: Third-year Bachelor of Science in Public Health Sciences.

Biography: Kerrie is a mature student from Cork City. Kerrie is a Quercus College Scholar for the years 2019/2020 and 2020/2021, she is working towards a research-based career in public health. Epidemiology, the determinants of health and medical sociology would be Kerrie’s main academic interests.

Current Project: Title: How to read and grade a research paper and the evidence for why. Project Details: Research paper/report writing is a key skill for all health researchers.  The craft of writing this report can be challenging and teaching the craft is even more challenging.  Most healthcare research papers are written in IMRAD format: Introduction, Methods, Results And Discussion, but when it comes to teaching paper/report writing, it is unclear where the emphasis should be. Literature suggests that when deciding if a paper is worth reading, you should do so based on the design of the methods section. However, there is no evidence that this is what happens in practice. The questions when teaching are thus: should one place more emphasis on particular sections? how does one assess the research paper/report? what marks should be assigned to each section? We will answer these questions.

Stefania Pirosca

Name: Stefania Pirosca

Education: MSci Neuroscience with Psychology, University of Aberdeen, Scotland, UK.

Biography: Stefania Pirosca graduated from the University of Aberdeen, Scotland with a MSci in Neuroscience with Psychology. Stefania worked before as an intern in health research on a project concerned with the improvements needed for trial design.

Current Project: The project Stefania is currently working on has the potential of generating some real evidence that will draw more attention to how urgent it is for the current research to get better. Currently Stefania is working on the Scandal of Bad Research. In 1994 the late Doug Altman wrote a seminal piece titled ‘The scandal of poor medical research’ which drew attention to researchers using the wrong techniques. Doug later said that his only regret about his article is that he didn’t use the word ‘bad’ instead of ‘poor’.  The work Stefania is doing over the summer is to support through actual data from Cochrane library Doug’s preferred word– ‘bad’ – and show how methodologically bad many trials are, what this means, and what needs to change. Stefania previously worked as an intern in health research on a project concerned with the improvements needed for trial design.

 

Learning about Clinical Trials

A useful resource on the MRC-NIHR TMRP webpage, aims to raise awareness and understanding of trials methodology research including how it can benefit patients.

Access the “What is Trials Methodology Research?” webpage here

 

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