What is the PRioRiTy Study?

The Prioritising Recruitment in Randomised Trials study (PRioRiTy) identified research priorities for how to improve the process of how people are recruited to clinical trials. The study was a priority setting partnership (PSP) based on the methods of the James Lind Alliance (JLA). The JLA (UK) brings patients, carers and healthcare professionals together in Priority Setting Partnerships. These partnerships identify and prioritise unanswered questions about healthcare that the public, carers and professionals jointly agree are the most important.  The aim of this is to help ensure that those who fund health research are aware of what future research will really matter in everyday use.

The PRioRiTy PSP was focussed on methodological uncertainties rather than on treatment uncertainties and therefore a modified JLA approach was developed and used.

The PRioRiTy study was the first time a modified JLA approach was used to address methodological uncertainties within randomised trials. This was an Ireland and UK initiative and was funded by the Health Research Board (Ireland) under the Knowledge Exchange and Dissemination Scheme Awards (2015).

What do we mean by “Trials”?

A randomised trial is a type of research study that compares groups of people receiving different interventions and looks at which of these improves health outcomes the most. An intervention is anything that aims to make a change to someone’s health. For example, providing a counselling service, giving a drug, or giving people information and training are all described as interventions. The decision about which group a person joins is at random (for example, by a computer deciding the group the person is put into), which means that a person is put into one of the groups by chance.

Challenges in how randomised trials are planned and carried out are often experienced by researchers at different stages of the research project. For example, difficulty in recruiting people to a trial often results in a delay in completing the trial or difficulty in using the trial results to make informed decisions about clinical care. For this reason, it is important that research into how trials might be ‘done better’ is considered so that the strength of trials’ findings are increased.

Who took part in the survey?

  • Members of the public who have been asked to take part in a randomised trial by a health professional or researcher
  • Members of the public who has taken part in a randomised trial steering committee
  • Health professionals or any member of a research team who has ever been involved in helping people to join randomised trials
  • People who have designed, conducted, analysed or reported on randomised trials
  • People who have experience of the methods of randomised trials.

Who is running this project?

A Steering Group that represents the public, researchers, health professionals and trial experts carried out this project (many of whom are in the photograph on the left – NEED TO ADD PHOTO – did I send?). The project, supported by the Health Research Board (HRB, Ireland) and the James Lind Alliance (JLA, England) is based on a process developed by the James Lind Alliance, which brings patients, carers and healthcare professionals together in Priority Setting Partnerships. This partnership identified and prioritised unanswered questions about methodological uncertainties in recruitment to trials that the public , carers and professionals jointly agree are the most important. The aim of this is to help ensure that those who fund health research are aware of what future research will really matter in everyday use.

Who developed / conducted the PRioRiTy study?

The PRioRiTy study was developed and conducted by the Health Research Board- Trials Methodology Research Network, the MRC-Hubs for Trials Methodology Research network, Trial Forge, The James Lind Alliance and the National Institute for Health Research. The project was governed by a Steering Group with public, researcher, health professional and trial expert representation.

Steering Group Members

Declan Devane - Director of the Health Research Board-Trials Methodology Research Network / Project Principal Investigator and steering group Chairperson

Declan Devane is Professor of Midwifery at the National University of Ireland Galway and Director of the Health Research Board-Trial Methodology Research Network. He has led a number of clinical trials recruiting from 100 to over 3000 participants and serves on a number of Trial Steering Committees and Data Monitoring Boards. He is also an Associate Editor with the Cochrane Pregnancy and Childbirth Group, an Associate Senior Lecturer with the UK Cochrane Centre.

Amanda Blatch-Jones - Lead Senior Research Fellow for the Research on Research programme, NIHR Evaluation, Trials and Studies Coordinating Centre

Amanda Blatch-Jones is the Lead Senior Research Fellow for the Research on Research programme, which is an internal programme of work contracted through the NIHR Evaluation, Trials and Studies Coordinating Centre. She is responsible for leading the RoR team and the strategic development of the programme. Amanda has worked at NETSCC for the past eight years in various roles including portfolio management of HTA projects and the Technology Assessment Reviews (TARs) programme. She has experience of conducting research funded by the Health Technology Assessment (HTA) programme as well as holding numerous research positions at the University of Southampton since 2001.

Chris Bray - Head of Clinical Research at the University of Oxford’s Diabetes Trials Unit

Chris Bray is the Head of Clinical Research at the University of Oxford’s Diabetes Trials Unit. He has over 20 years’ experience working in trial administration and management, primarily in relation to large-scale international trials. Since 2014 he has been an active member of the Working Group that oversees the UK Trial Managers’ Network.

Peter Brocklehurst - Professor of Women's Health and Director of the Birmingham Clinical Trials Unit

Peter Brocklehurst is Professor of Women's Health and Director of the Birmingham Clinical Trials Unit at the University of Birmingham. Peter is an obstetrician and clinical epidemiologist, with expertise in randomised controlled trials and observational epidemiology. He is an NIHR Senior Investigator and Fellow of the Academy of Medical Sciences.

Mike Clarke - Director of the MRC All Ireland Hub for Trials Methodology Research

Mike Clarke is the Director of the MRC All Ireland Hub for Trials Methodology Research, based in the Centre for Public Health at Queen’s University Belfast and current Chair of the Network of Hubs. He has worked for more than two decades on rigorous assessments of the effects of health care and other interventions and actions. He is the former Director of the UK Cochrane Centre, which is part of The Cochrane Collaboration, a global effort to prepare summaries of the effects of health interventions and is Co-ordinating Editor of the Cochrane Methodology Review Group, which prepares and maintains systematic reviews relevant to the methods of randomised trials, reviews and other evaluations of interventions, actions and strategies. He has worked on more than 30 systematic reviews in a wide range of areas, including healthcare interventions, survey design, publication bias, and civil service pay in resource poor settings; and been actively involved in some of the largest ever randomised trials in areas as varied as maternity care, breast cancer, poisoning and stroke. Mike is one of the founders of Evidence Aid, which is improving access to reliable information of relevance to people involved in disaster risk reduction, planning, response and recovery.

Mary Clarke Moloney - Clinical Operations Manager for the Health Research Institute, University of Limerick

Mary is the Clinical Operations Manager for the Health Research Institute, University of Limerick. Mary is a qualified registered nurse since 1994 and was awarded her PhD from the University of Limerick in 2006. She is an experienced clinical researcher having worked in the area of clinical research since 2002. In her time working in clinical research, she has led and co-ordinated many research projects from concept to publication. Mary is the outgoing Chair of the Irish Research Nurses Network (IRNN); during her term she led on the introduction of an Orientation Program and a Competency Framework for Irish Clinical Research Nurses.

Abdel Douiri - Senior Lecturer in Biostatistics at King’s College London (KCL)

Abdel Douiri is a Senior Lecturer in Biostatistics at King’s College London (KCL). His research interests include clinical trials design and predictive medicine. Abdel is module leader of further epidemiology and statistics for public health and co-lead of the statistical consultancy services at KCL. He is also a statistical advisor with the Research Design Service London, Biomedical Research Centre, and King’s College Hospital.

Sandra Galvin - Coordinator for the HRB-TMRN

Sandra Galvin is the Programme Manager for the HRB-TMRN and a Senior Research Fellow based in the School of Nursing and Midwifery, National University of Ireland Galway. Sandra is responsible for the development , strategic direction, implementation and running of the HRB-TMRN activities across all 5 Irish university partner sites, as well as responsible for establishing international collaborations for the network. Sandra graduated with a PhD in Bacteriology in 2010 from NUI Galway and also holds an BSc in Microbiology from UCC. Sandra has previously worked on research projects across NUI Galway and the Royal College of Surgeons in Ireland.

Carrol Gamble, Professor of Medical Statistics at the University of Liverpool

Carol’s main area of research is in the design, conduct and analysis of clinical trials. Carrol predominantly works in clinical trials involving children and young people and has particular interests in the recruitment and retention of participants. Carrol is a member of the North West Hub for Trials Methodology Research and Chairs the Statisticians Operational Group within the UKCRC registered clinical trials units.

Patricia Healy – Postdoctoral Researcher, School of Nursing and Midwifery, NUI Galway

I am a midwife and children’s nurse. I trained and worked as a midwife in the Coombe women’s and infants Hospital in Dublin and as a children's nurse in Our Lady’s Hospital, Crumlin. My clinical speciality is special and intensive neonatal care where I spent many very rewarding clinical practice years. I hold a Nursing Degree and a Midwifery Masters from Trinity College Dublin, a Diploma in Health Services Management from University Limerick and a PhD from NUI, Galway. My PhD focused on cerebral palsy through which I developed a particular interest in quality and safety, risk management and clinical negligence in healthcare especially in the maternity services. As part of my PhD experience I worked for a time as a Clinical Risk Advisor in the Clinical Indemnity Scheme, which is a branch of the State Claims Agency. I am currently employed as a post-doctoral researcher at the school of Nursing and Midwifery, NUI, Galway. Through this post-doctoral work I have developed an interest in research methodology, clinical trials, systematic reviews, meta-analyses and evidence synthesis. I continue to indulge my great love of neonatal care by teaching across the undergraduate and postgraduate midwifery programmes whenever the opportunity arises.

Joan Jordan - Public Representative

Joan Jordan was diagnosed with Multiple Sclerosis in 2010 and has participated in a clinical trial for two and half years. A Computer Science graduate, she had previously worked across the globe for over a decade on mobile communications projects. She is currently retraining and is studying medicine research and design on the 2015-16 EUPATI programme.

Beccy Maeso - Senior Research Manager, National Institute for Health Research Evaluation Trials and Studies Coordinating Centre (NETSCC)

I am a Senior Research Manager at the National Institute for Health Research Evaluation Trials and Studies Coordinating Centre (NETSCC) based at the University of Southampton.  I lead the team that manages the James Lind Alliance (JLA).   We provide the secretariat function to the JLA. This includes recruiting and training JLA Advisers, coordinating PSPs, looking after JLA communications and liaising with other parts of the National Institute for Health Research.  I also support the work of JLA Advisers and act as a facilitator for some JLA Priority Setting Partnership final workshops.

Derick Mitchell - CEO of IPPOSI

Derick Mitchell (PhD) commenced his appointment as CEO of IPPOSI in August 2015. From 2011-2015, Derick was Communications Manager with the EU Joint Programme – Neurodegenerative Disease Research (JPND), where he was responsible for developing external communications strategies and supporting stakeholder engagement activities with patient organisations, researchers and industry. Derick has a large experience of scientific communications, patient/public engagement, multi-stakeholder management and advocacy through previous positions at both the European and the national level (JPND, BBMRI Stakeholders’ Forum, REMEDI NUI Galway), and has a strong interest in the area of patient involvement in research. Derick graduated with a BSc. (Hons) in Biotechnology from NUI Galway (2000) followed by a PhD in Molecular Medicine from University College Dublin (2004). Outside of IPPOSI, Derick spends his free time attempting to influence his two toddler daughters.

Martin O Donnell - Associate Professor of Translational Medicine at National University of Ireland Galway

Martin O’Donnell is Associate Professor of Translational Medicine at NUI Galway and Associate Director of the Clinical Research Facility, Galway. Prof. O’Donnell’s research focus is Cardiovascular prevention, with a particular focus on stroke and vascular cognitive impairment. He is Principal Investigator of numerous research projects, including INTERSTROKE, a large international epidemiological study or risk factors for stroke (over 26,000 participants recruited from 32 countries). He leads the INTERSTROKE network of investigators, which include stroke researchers from high, middle and low income countries, who plan to undertake clinical trials in acute stroke management and prevention. Prof. O’Donnell has published over 90 peer review manuscripts including in the area of methodology and was recently awarded a European Research Council (ERC) starter grant for the ‘Clarifying Optimal Sodium Intake Project’ (COSPIT) study. He serves on the Steering committee on numerous international clinical trials in Cardiovascular prevention (AVERROES, APOLLO, and COMPASS), and has been Principal Investigator of device trials (VENOPTS) and behavioural interventions (SLEPT) in vascular medicine.

Sue Pavitt - Head of Division for Applied Health and Clinical Translation, Director Dental Translation and Clinical Research Unit,University of Leeds.

Sue is a methodologist specializing in clinical trial design and delivering patient-centric trials. She works as: Specialty lead for the Oral & Dental Health National Institute of Health Research (NIHR) Clinical Research Network(CRN); Chairs the Multiple Sclerosis Clinical Trials Network(UK MS-CTN); and is the Academic Lead for EUPATI-UK – European Patient Advocacy for Therapeutic Innovation.

Hannah Reay - NIHR Clinical Research Network (CRN) West Midlands and the Intensive Care Foundation’s Deputy Director of Research for Nurses and Allied Health Professionals.

Hannah recently coordinated the Foundation’s James Lind Alliance Intensive Care Research Priority Setting Partnership. An ICU nurse by background, she coordinated the development of competencies for Critical Care Medicine across Europe (CoBaTrICE) and was involved in promoting recruitment to a national multi-centre critical care trial before joining the CRN where she supports staff to deliver clinical research across multiple specialities.

Valerie Smith - Research Fellow with the Health Research Board-Trials Methodology Research Network

Valerie is a part-time Assistant Prof in Midwifery at the School of Nursing and Midwifery, Trinity College Dublin and a part-time Research Fellow with the Health Research Board-Trials Methodology Research Network NUI Galway. Valerie’s specific areas of clinical and research expertise are methods for assessing fetal wellbeing, intrapartum care, systematic reviews, randomised trial and survey research methods.

Derick Stewart - Associate Director for patient and public involvement for the National Institute for Health Research Clinical Research Networks Coordinating Centre

Born in Scotland, Derek Stewart was treated successfully for cancer of the larynx in 1995. A former teacher working with challenging pupils, Derek became involved in numerous aspects of patient involvement at a local, network and national levels. A blog of his views can be found at Making a Difference. As former Chair of the National Cancer Research Institute Consumer Liaison Group, Derek assisted with the increase in patient participation in the establishment and work of the National Cancer Research Institute. Derek is a Trustee for onCore UK, the national cancer tissue resource, Chair of the Confederation of Cancer Biobanks and a member of the Cancer Reform Strategy Advisory Board. From 2001 until 2006 Derek was Chair of Gedling Primary Care Trust in Nottinghamshire. In 2005 he took up the role as Chair of Nottingham City Crime and Drugs Partnership. Derek still works as a freelance consultant with his own company providing training on patient and public involvement across charity and public sector. This contribution to health services in particular cancer led to being awarded an OBE in the Queen’s Birthday Honours list 2006. Derek is Associate Director for patient and public involvement for the National Institute for Health Research Clinical Research Networks Coordinating Centre and is Chair of the Throat Cancer Foundation. Read about what people say about us.

Shaun Treweek - Health Services Research Unit 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 leads an initiative called Trial Forge that aims to be more systematic about how we generate and use research evidence in making trial design, conduct, analysis and reporting decisions.

Caroline Whiting - Research Manager, National Institute for Health Research Evaluation Trials and Studies Coordinating Centre (NETSCC)

I am a Research Manager at the National Institute for Health Research Evaluation Trials and Studies Coordinating Centre (NETSCC) based at the University of Southampton.  My work as part of the team that manages the James Lind Alliance (JLA) gives me experience of a wide range of Priority Setting Partnerships and the different approaches they take to completing the JLA PSP method.

Paula Williamson - Director of the Centre for Medical Statistics and Health Evaluation at the Clinical Trials Research Centre of the University of Liverpool

Paula Williamson is Director of the Centre for Medical Statistics and Health Evaluation at the Clinical Trials Research Centre of the University of Liverpool. Her research activities are focused on the development and application of statistical methodology to inform the evidence base for NHS priorities. In 2008 Professor Williamson led a successful bid for an MRC North West Hub for Trial Methodology Research (NWHTMR). The mission is to create a world-class centre where methodological issues facing the clinical trials community can be investigated, the overall aim being to improve patient care by improving the validity and relevance of the healthcare evidence base. Drug safety remains an important issue for all stakeholders, and represents a cross-cutting theme in this initiative. The NWHTMR will be key in tackling the methodological issues associated with assessing harm and developing interventions to reduce the burden of adverse drug reactions. Professor Williamson has been Associate Director of the NIHR Medicines for Children Research Network (MCRN) and Director of the MCRN Clinical Trials Unit since 2005. The MCRN CTU has been awarded major trial grant funding to evaluate the efficacy and safety of paediatric medicines. In 2008, she was appointed to the Secretary of State for Transport’s Honorary Medical Advisory Panel on Driving and Disorders of the Nervous System.