ON TRACK Network Trial Concept Development Workshop February 2019
The third ON TRACK Network Trial Development Workshop took place at the Liggins Institute, University of Auckland, in February. This two-day workshop followed workshops held in 2017 and 2018.
The aim of these workshops is to develop promising clinical trial concepts into collaborative New Zealand multi-centre, investigator-led clinical trials. The workshops help investigators to develop their concepts to a point where they can secure competitive grant funding, with the intention that their concepts evolve into ON TRACK Network supported clinical trials.
The workshops are set-up and designed to support investigator groups from across the country and across disciplines interested in developing clinical trials to optimise health for pregnant women and their babies throughout New Zealand.
Forty nine participants took part in this year’s workshop, with three research concepts developed and refined during group work and a mock grant panel session. The three clinical trial concepts detailed below were selected by the ON TRACK Network National Executive Committee for development from a number of submissions received in response to a call for applications from across the country.
Each individual whose concept was selected (concept Lead Investigator), was paired with, and supported by a nominated facilitator who is an expert in the field with content knowledge and senior clinical trials experience. The entire workshop process is supported by the facilitators, but also faculty experts, providing expertise across allied health, biostatistics, health economics, clinical trial design, funding, and Māori health/research.
Three concepts were submitted and selected for the 2019 workshop:
1. Sarah Harris (Paediatrician, Canterbury DHB and Senior Lecturer, University of Otago): Communication and relationship focussed intervention to improve developmental and infant mental health outcomes at 2 years in children born very preterm (Facilitator: Trecia Wouldes)
2. Esther Calje (Associate Clinical Charge Midwife, Christchurch Women’s Hospital, Canterbury DHB): A pilot randomised clinical trial of blood transfusion versus intravenous iron for the treatment of severe postpartum anaemia (Facilitator: Jonathan Morris)
3. Annette Murphy (Clinical Nurse Specialist, Special Care Baby Unit, North Shore Hospital, Waitemata DHB): Preventing cold stress in the newborn while facilitating delayed cord clamping in emergency and elective caesarean section (Facilitator: Jennifer Dawson)
All concept Lead Investigators provided a ‘concept pitch’ covering:
• Background and Rationale
• Aims and Objectives
• Design and Methodology
• Research Impact
• Māori Responsiveness
• Team Capability
The ongoing development of the concepts focused on the above structure throughout the course of the workshop.
Johnathan Morris (Professor Obstetrics & Gynaecology, University of Sydney, NSW)
Jennifer Dawson (Nurse Researcher & Deputy Director Newborn Research Centre, Victoria
Trecia Wouldes (Developmental Psychologist and Associate Professor, University of Auckland)
Māori research advisor: Helen Wihongi
Consumer Advisor: Jenny Warren
Review Panel: Jane Harding, Jenny Warren, Jonathan Morris, Trecia Wouldes, Jennifer Dawson, Helen Wihongi, Thomas Lumley.
The workshop opened with introductory presentations to set the scene for the remainder of the workshop. Presentations were:
ON TRACK Network overview, workshop overview, and developing a clinical trial (Katie Groom)
HRC Pathway to impact – considerations in your trial’s development & grant submission (Lucy Pomeroy)
Māori responsiveness – what does this really mean? How to respond throughout your trial’s development & progress (Bev Lawton & Wendy Dallas-Katoa)
Health Economics – why do you need to consider this now? (Richard Edlin)
Central Coordinating Research Hub (Chris McKinlay)