May 2015 HRB invests €10 million in four new clinical trial networks

Stroke patients, mothers and babies, primary care and intensive care patients will all benefit from the four new clinical trial networks, which will improve people’s health and patient care by addressing important research questions.

Dr Graham Love, the Chief Executive at the Health Research Board (HRB) says,
‘Clinical trials matter. These new HRB networks will show whether specific interventions work, or indeed don’t work, in the areas of stroke, intensive care, perinatal care and primary care.

The clinical trial network approach is effective. We know this because we have our own tried and tested network in Cancer called ICORG*, which is co-funded by the Irish Cancer Society.  Since the HRB started funding ICORG in 2001, it has attracted 270 international trials to Ireland, provided more than 13,000 Irish cancer patients with access to new research treatments and drawn in €6.95 million in funding from industry in the last three years alone’.

Following a rigorous application process, an international panel of experts selected the four networks based on their potential for having outstanding health, scientific, societal and economic potential. Each network is led by exceptional individuals with a proven track record of delivering innovative health research that makes a difference to patients.

The four Clinical Trials Networks are:

• HRB Irish Stroke Clinical Trials Network led by Professor Peter J Kelly, Mater University Hospital and University College Dublin (UCD).
• HRB Irish Critical-Care Clinical Trials Group led by Professor Alistair Nichol, St Vincent’s University Hospital and UCD.
• HRB Ireland Perinatal Clinical Trials Network co-led by Professor Fergal Malone, Rotunda Hospital and Royal College of Surgeons in Ireland and Professor Louise Kenny, Cork University Maternity Hospital and INFANT, University College Cork (UCC).
• HRB Irish Primary Care Trials Network led by Professor Andrew Murphy, Foundation Professor of General Practice NUI Galway and General Practitioner Turloughmore, County Galway.

Short case studies on each Clinical Trials Network, the trials they will run and quotes from the network leads are provided below.

The HRB Irish Stroke Clinical Trials Network led by Professor Peter J Kelly, Mater University Hospital and University College Dublin

Stroke is the second leading cause of death in the world, the leading cause of new disability, and a major cause of dementia and health costs.

‘This Stroke Clinical Trials Network will give Irish patients access to cutting edge new treatments with the potential to prevent strokes, or to improve emergency treatment and recovery after stroke,’ says Professor Kelly, Mater University Hospital and University College Dublin.

'We recently saw the benefit to Irish patients of participating in clinical trials via Irish involvement in the ESCAPE trial. This trial was one of the first to prove that emergency clot extraction for carefully selected patients after stroke resulted in a 3-fold improvement of disability, and reduced the risk of death by half, from 20% to 10%. Irish patients were among the first in Europe to benefit from the treatment, which they otherwise would not have accessed.'

In the Network, Irish researchers in hospitals will: -

• Join several new international trials of new treatments for emergency care, prevention, and recovery after stroke.
• Lead a new clinical trial aiming to prevent second strokes and heart attack after first stroke.
• Train new doctors, nurses, and therapists in how to perform safe high-quality clinical trials, and will work with patient groups and the private sector to bring new treatments to patients with stroke.

The Network will initially involve eight Irish hospitals, six leading universities, and all seven Hospital Groups, including colleagues from UCD, RCSI, Trinity College, UCC, NUI Galway, and University of Limerick. It will have strong links with international researchers in the UK, Europe, and North America.

In addition to the HRB, other Network partners are the Irish Heart Foundation, who will fund new Stroke Research Nurses, and seven industry partners, who will fund education and training activities.

The HRB Irish Critical-Care Clinical Trials Group (IC-CTG) led by Professor Alistair Nichol, St Vincent’s University Hospital and UCD

Thousands of critically ill patients pass through our intensive care units (ICU) each year. Sadly the nature of their conditions can often result in death, or mean they survive with a long term disability. The HRB Irish Critical-Care Clinical Trials Group will bring together doctors, nurses and researchers to test new treatments that can improve outcomes for these patients.

‘Our network will offer ICU patients the highest quality care, give them access to the latest innovations in intensive care and ensure future patients benefit from the lessons learned in national and international research. The group includes the academic leadership in our speciality and encompasses more than 75% of all the ICU capacity in Ireland,’ says Professor Alistair Nichol, Director of the network, St Vincent’s University Hospital and UCD.

Initial work to be addressed by the IC-CTG:

• PHARLAP- will establish whether the way we ‘set’ the breathing machine helps reduce further lung damage in patients with a severe lung disease (Acute Respiratory Distress Syndrome  or ‘ARDS’). A small research study by some of the group members showed that reducing the size of each breath in conjunction with an occasional sustained deep breath through the ventilator appeared to reduce further damage to the lungs. But the study size was too small to make definitive conclusions. So a larger study, which this HRB network now makes possible, will assess whether patients with ARDS are better off on this PHARLAP breathing strategy.
• TRANSFUSE- Does giving ‘fresher’ blood versus ‘older blood’ in transfusions make a difference to patients who are admitted to ICU. This study will result in a worldwide practice change if it finds freshest available blood use is best for ICU patients, but if there is no difference this will provide great confidence to blood banks that current practice is optimal.
• The network will also carry out test studies to determine which of the common treatments used to help reduce bleeding from the stomach when people are very unwell is best.
• The network will also provide extra training for junior doctors and nurses in Ireland, so they can be future world leaders in research within the Irish health system.

Prof Nichol adds,

‘We will be conducting studies with colleagues from Australia and New Zealand where a similar group to ours have made an enormous impact on improving ICU care. We very much hope to replicate their success in Ireland’.

HRB Ireland Perinatal Clinical Trials Network co-led by Professor Fergal Malone, Rotunda Hospital and RCSI and Professor Louise Kenny, Cork University Maternity Hospital and INFANT, UCC

Unfavourable pregnancy and birth outcomes can have devastating effects and lifelong consequences for infants and their families. 
‘The HRB Ireland Perinatal Clinical Trials network will be home to more than 200 multidisciplinary researchers whose focus will be to improve care of pregnant women and new born babies by answering important research questions’,  according to Professor Fergal Malone, Rotunda Hospital and the Royal College of Surgeons in Ireland. ‘The network brings together leading Irish obstetric, midwifery and neonatal researchers with more than ten years’ experience in conducting important research into women and children’s health.

The initial work programme for the HRB Ireland Perinatal CTN includes:

• The STRIDER trial, which will examine on the use of sildenafil citrate (Viagra) for the treatment of babies in the womb whose growth is severely compromised and for whom no other treatment exists.
• The PARROT trial, which will examine the use of a novel testing method for diagnosing Pre-eclampsia (PET), a potentially life-threatening pregnancy complication caused by high blood pressure.
• The TEST pilot study - the first national drug trial in pregnancy, assessing the use of aspirin in low risk women to prevent pregnancy complications.
• MINT - a drug trial to help assess the best treatment for babies born with breathing difficulties.
• IRELAND - a drug trial to help assess the best treatment to prevent pre-eclampsia in women with Diabetes.

Launching a nationwide follow up programme for the children who participate in these and other studies.

Establishing a research programme targeted at the methodology of how we design, conduct, analyse and report clinical trials.

‘Clinical trials in pregnancy and new-born babies are challenging and there are only a handful of such networks globally’, adds Prof Louise Kenny, Cork University Maternity Hospital and INFANT at UCC. ‘Each partner already has extensive, international connections and a balanced portfolio of trials and interventions. This collaborative network will create a critical mass that ensures  Ireland remains an international leader in the delivery of interventions that save lives and improve the health of mothers and babies internationally’.

Background: This network represents collaboration between two established research groups; the SFI Irish Centre for Fetal and Neonatal Translational Research (INFANT) and HRB Perinatal Ireland. INFANT has been a world-leading centre for innovative research and the development of novel interventions for pregnancy and new-borns. Perinatal Ireland is a consortium of clinicians from the seven largest maternity Hospitals on the island of Ireland, which when combined, provides a potential research cohort of over 55,000 babies per annum. Perinatal Ireland research outputs have already underpinned the development of at least two national clinical guidelines.

The HRB Irish Primary Care Trials Network led by Professor Andrew Murphy, Foundation Professor of General Practice NUI Galway and General Practitioner Turloughmore, County Galway

Primary care, often provided by a local GP, is the first port of call for most patients when they are sick. More than 20 million GP consultations take place in Ireland each year.

‘Ninety percent of all health problems can be addressed by GPs and primary care services, so it is vital that GPs have firm evidence on which to make informed decisions about which medication or treatment is right for each patient. This network will deliver such evidence, first in relation to common conditions such as urinary tract infection and also how to manage patients on many medicines effectively,’ says Prof Andrew Murphy, Foundation Professor of General Practice NUI Galway and General Practitioner Turloughmore, County Galway.

Initial work to be addressed in the HRB IPC network:

• Trial 1: Establish whether an antibiotic, or an over-the-counter painkiller, has a better outcome for patients with simple urinary tract infections.
• Trial 2: Help GPs prescribe the most appropriate combination of medications for older patients who are already on a lot of different drugs.
• Bring together all the key people in Ireland who are interested in running clinical trials in primary care involving GPs and their patients.
• Explore patient safety in primary care and will investigate how best to recruit patients and GPs into clinical trials.
• Initiate an education component teaching primary care staff how to best conduct clinical trials and support people to work closely together to plan and conduct clinical trials and to share the results with GPs and patients.

The partners bring a wealth of prior experience in the area along with an already developed, data commissioner approved, ICT system that enables the upload and storage of anonymous, comparative clinical data direct from GP clinics.

The Network has partners from NUI Galway, the HRB Clinical Research Facility, Galway, the Royal College of Surgeons in Ireland and the HRB Centre for Primary Care Research.

ENDS