Integrating trials into a whole-population cohort of children and parents: statement of intent (trials) for the Generation Victoria (GenV) cohort
Melissa Wake, Yanhong Jessika Hu, Hayley Warren, Margie Danchin, Michael Fahey, Francesca Orsini, Maurizio Pacilli, Kirsten P Perrett, Richard Saffery, Andrew Davidson
BMC Medical Research Methodology | BMC | Published : 2020
BACKGROUND: Very large cohorts that span an entire population raise new prospects for the conduct of multiple trials that speed up advances in prevention or treatment while reducing participant, financial and regulatory burden. However, a review of literature reveals no blueprint to guide this systematically in practice. This Statement of Intent proposes how diverse trials may be integrated within or alongside Generation Victoria (GenV), a whole-of-state Australian birth cohort in planning, and delineates potential processes and opportunities. METHODS: Parents of all newborns (estimated 160,000) in the state of Victoria, Australia, will be approached for two full years from 2021. The cohort ..View full abstract
Awarded by Australian National Health & Medical Research Council (NHMRC)
Generation Victoria is supported by the Paul Ramsay Foundation, the Victorian Government, the Murdoch Children's Research Institute and the Royal Children's Hospital Foundation. Research at the Murdoch Children's Research Institute is supported by the Victorian Government's Operational Infrastructure Support Program. MW is supported by Australian National Health & Medical Research Council (NHMRC) Principal Research Fellowship 1160906). MD is supported by the David Bickart Clinician Scientist Fellowship, University of Melbourne. KPP is supported by a Melbourne Children's Clinician Scientist Fellowship.All statements in this report are solely those of the authors and do not necessarily represent the views of the Paul Ramsay Foundation, the Victorian Government, the Murdoch Children's Research Institute or the Royal Children's Hospital.