Trial Steering Committee (TSC)
The role of the Trial Steering Committee (TSC) is to oversee all aspects of the POLAR trial and act as the key reference group for clinical expertise to ensure the safety of the study participants. In addition, the Trial Steering Committee will be responsible for overall trial direction and coordination of subcommittees and taskforces.
The main responsibility of this committee is to provide trial oversight including overall responsibility for the scientific integrity of the protocol and the assessment of study quality and conduct.
This Committee will have responsibility for monitoring trial progress with regard to:
- Overseeing the day-to-day conduct of the trial, including safety oversight activities, and/or acting on advice from the POLAR Data Safety Monitoring Committee (DSMC)
- Overseeing trial progress/milestones (i.e. recruitment accruals, timelines etc.) and
- Overseeing adherence/compliance to the protocol and adherence/compliance to good research practices.
The Chair of the Trial Steering Committee (TSC) will be Associate Professor David Tingay.
The TSC will meet quarterly via videoconference during the recruitment phase of the study. During the follow-up phase of the study, meetings will decrease to 6-monthly. The TSC will meet face to face at least once annually.
Trial Coordinating Centre (TCC) / Data Coordinating Centre (DCCe)
The trial is managed collaboratively by the Trial Coordinating Center (TCC) and the Data Coordinating Center (DCCe), which is based at the Murdoch Children’s Research Institute (MCRI), Melbourne Australia.
The Trial Coordinating Center is responsible for overall clinical leadership of the trial and its functions include:
- Providing leadership in directing the clinical aspects of protocol development and implementation
- Developing training materials and instructions for the intervention algorithms and other clinical procedures
- Overseeing study governance
- Coordinating protocol specific training of research teams at participating hospitals in collaboration with each Regional Lead.
The Data Coordinating Center (DCCe) is responsible for research operations and supporting the TCC and research network to assure collaboration across participating hospitals, along with standardisation and uniformity of procedures, to yield high-quality data. The DCCe will serve as the liaison between the participating hospitals, the scientific leadership team, and the Data Safety Monitoring Committee.
Regional Leads (RLs)
The Amsterdam University Medical Center (Netherlands), the University of Oxford's National Perinatal Epidemiological Unit (NPEU) Clinical Trials Unit (UK), and the Hospital of the University of Pennsylvania/Children’s Hospital of Philadelphia (USA), will be the principal International Partner Research Organisations for the POLAR clinical trial.
Each organisation will act as the respective Regional Lead for the Netherlands, the United Kingdom and North America, in order to streamline study implementation, ethics processes and governance aspects of the trial.
The three International Partners have an established and independently funded research structure with an outstanding history in leading large influential neonatal trials.
Each Regional Lead will also provide real-time clinical support to other participating centres within their jurisdiction, to account for the variation in time zones globally.
Each Regional Lead will work under the direct supervision of the Trial Coordinating Centre (TCC) in Melbourne, Australia and be responsible for providing leadership and oversight for their respective jurisdiction.