Integrating trials into a whole-population cohort of children and parents: statement of intent (trials) for the Generation Victoria (GenV) cohort
Abstract 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 th...
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| Format: | Article |
| Language: | English |
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BMC
2020-09-01
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| Series: | BMC Medical Research Methodology |
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| Online Access: | http://link.springer.com/article/10.1186/s12874-020-01111-x |
| _version_ | 1818976012370706432 |
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| author | Melissa Wake Yanhong Jessika Hu Hayley Warren Margie Danchin Michael Fahey Francesca Orsini Maurizio Pacilli Kirsten P. Perrett Richard Saffery Andrew Davidson |
| author_facet | Melissa Wake Yanhong Jessika Hu Hayley Warren Margie Danchin Michael Fahey Francesca Orsini Maurizio Pacilli Kirsten P. Perrett Richard Saffery Andrew Davidson |
| author_sort | Melissa Wake |
| collection | DOAJ |
| description | Abstract 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 design comprises four elements: (1) consent soon after birth to follow the child and parent/s until study end or withdrawal; retrospective and prospective (2) linkage to clinical and administrative datasets and (3) banking of universal and clinical biosamples; and (4) GenV-collected biosamples and data. GenV-collected data will focus on overarching outcome and phenotypic measures using low-burden, universal-capable electronic interfaces, with funding-dependent face-to-face assessments tailored to universal settings during the early childhood, school and/or adult years. Results For population or registry-type trials within GenV, GenV will provide all outcomes data and consent via traditional, waiver, or Trials Within Cohorts models. Trials alongside GenV consent their own participants born within the GenV window; GenV may help identify potential participants via opt-in or opt-out expression of interest. Data sharing enriches trials with outcomes, prior data, and/or access to linked data contingent on custodian’s agreements, and supports modeling of causal effects to the population and between-trials comparisons of costs, benefits and utility. Data access will operate under the Findability, Accessibility, Interoperability, and Reusability (FAIR) and Care and Five Safes Principles. We consider governance, ethical and shared trial oversight, and expectations that trials will adhere to the best practice of the day. Conclusions Children and younger adults can access fewer trials than older adults. Integrating trials into mega-cohorts should improve health and well-being by generating faster, larger-scale evidence on a longer and/or broader horizon than previously possible. GenV will explore the limits and details of this approach over the coming years. |
| first_indexed | 2024-12-20T16:05:05Z |
| format | Article |
| id | doaj.art-541e07b1acf94f3ab0f34b0e30de6303 |
| institution | Directory Open Access Journal |
| issn | 1471-2288 |
| language | English |
| last_indexed | 2024-12-20T16:05:05Z |
| publishDate | 2020-09-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Medical Research Methodology |
| spelling | doaj.art-541e07b1acf94f3ab0f34b0e30de63032022-12-21T19:34:11ZengBMCBMC Medical Research Methodology1471-22882020-09-0120111510.1186/s12874-020-01111-xIntegrating trials into a whole-population cohort of children and parents: statement of intent (trials) for the Generation Victoria (GenV) cohortMelissa Wake0Yanhong Jessika Hu1Hayley Warren2Margie Danchin3Michael Fahey4Francesca Orsini5Maurizio Pacilli6Kirsten P. Perrett7Richard Saffery8Andrew Davidson9Murdoch Children’s Research Institute, The Royal Children’s HospitalMurdoch Children’s Research Institute, The Royal Children’s HospitalMurdoch Children’s Research Institute, The Royal Children’s HospitalMurdoch Children’s Research Institute, The Royal Children’s HospitalDepartment of Paediatrics, Monash UniversityMurdoch Children’s Research Institute, The Royal Children’s HospitalDepartment of Paediatrics, Monash UniversityMurdoch Children’s Research Institute, The Royal Children’s HospitalMurdoch Children’s Research Institute, The Royal Children’s HospitalMurdoch Children’s Research Institute, The Royal Children’s HospitalAbstract 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 design comprises four elements: (1) consent soon after birth to follow the child and parent/s until study end or withdrawal; retrospective and prospective (2) linkage to clinical and administrative datasets and (3) banking of universal and clinical biosamples; and (4) GenV-collected biosamples and data. GenV-collected data will focus on overarching outcome and phenotypic measures using low-burden, universal-capable electronic interfaces, with funding-dependent face-to-face assessments tailored to universal settings during the early childhood, school and/or adult years. Results For population or registry-type trials within GenV, GenV will provide all outcomes data and consent via traditional, waiver, or Trials Within Cohorts models. Trials alongside GenV consent their own participants born within the GenV window; GenV may help identify potential participants via opt-in or opt-out expression of interest. Data sharing enriches trials with outcomes, prior data, and/or access to linked data contingent on custodian’s agreements, and supports modeling of causal effects to the population and between-trials comparisons of costs, benefits and utility. Data access will operate under the Findability, Accessibility, Interoperability, and Reusability (FAIR) and Care and Five Safes Principles. We consider governance, ethical and shared trial oversight, and expectations that trials will adhere to the best practice of the day. Conclusions Children and younger adults can access fewer trials than older adults. Integrating trials into mega-cohorts should improve health and well-being by generating faster, larger-scale evidence on a longer and/or broader horizon than previously possible. GenV will explore the limits and details of this approach over the coming years.http://link.springer.com/article/10.1186/s12874-020-01111-xResearch methodologyRandomizationRegistry trialsMultiple baseline randomized trialsTrials within cohortsPopulation studies |
| spellingShingle | Melissa Wake Yanhong Jessika Hu Hayley Warren Margie Danchin Michael Fahey Francesca Orsini Maurizio Pacilli Kirsten P. Perrett Richard Saffery Andrew Davidson Integrating trials into a whole-population cohort of children and parents: statement of intent (trials) for the Generation Victoria (GenV) cohort BMC Medical Research Methodology Research methodology Randomization Registry trials Multiple baseline randomized trials Trials within cohorts Population studies |
| title | Integrating trials into a whole-population cohort of children and parents: statement of intent (trials) for the Generation Victoria (GenV) cohort |
| title_full | Integrating trials into a whole-population cohort of children and parents: statement of intent (trials) for the Generation Victoria (GenV) cohort |
| title_fullStr | Integrating trials into a whole-population cohort of children and parents: statement of intent (trials) for the Generation Victoria (GenV) cohort |
| title_full_unstemmed | Integrating trials into a whole-population cohort of children and parents: statement of intent (trials) for the Generation Victoria (GenV) cohort |
| title_short | Integrating trials into a whole-population cohort of children and parents: statement of intent (trials) for the Generation Victoria (GenV) cohort |
| title_sort | integrating trials into a whole population cohort of children and parents statement of intent trials for the generation victoria genv cohort |
| topic | Research methodology Randomization Registry trials Multiple baseline randomized trials Trials within cohorts Population studies |
| url | http://link.springer.com/article/10.1186/s12874-020-01111-x |
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