Pre-preposal Conference 2008 NCS Study Center NCS Study Director .ppt
PPT presentation 3 MB Posted
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- National Institute of Child Health and Human Development, National Children's Study (NCS) Centers
- Solicitation number
- Reference-Number-NIH-NICHD-NCS-08-21
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EAST-RFP No. NIH-NICHD--NCS-08-21E Amendment 002. Pre-proposal conference transcript and the Pre-proposal conference presentations.
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Peter C. Scheidt, MD, MPH Eunice Kennedy Shriver National Institute of Child Health and Human Development, Department of Health and Human Services Advancing The National Children’s Study Pre-proposal conference April 2, 2007
Pre-proposal Conference
| Welcome |
| Very brief overview and history |
| Structure of the NCS |
| Organization & components |
| Milestones and timeline |
| Questions and clarifications to follow |
Background and Rationale President’s Task Force on Environment and Health Risks to Children
Co-chairs Sec. HHS & Adm. EPA + 7 other cabinet member Charge: National strategies to control environ. risks Finds Existing studies limited in size and scope Longitudinal design to infer causality with multiple exposures and multiple outcomes Bold study needed to identify effects or ensure safety Children’s Health Act of 2000:“..authorize NICHD to conduct a national longitudinal study of environmental influences (including physical, chemical, biological, and psychosocial) on children's health and development”
Study Concepts Aims
Identify potential environmental effects: harmful, harmless, helpful For conditions and diseases of children, identify potential preventable causes National resource for future studies
| Hypothesis driven |
| Exposure begins with pregnancy |
| Has power to study uncommon high priority conditions (n~100,000) |
| Gene environment interaction |
| National resource for future studies |
Planning Process for the NCS
| Interagency Coordinating Committee: NICHD, NIEHS, CDC, EPA |
| Federally Chartered Advisory Committee* |
| Expert Working Groups |
Hypotheses Measures/methods
| Workshops* |
| Literature reviews/white papers* |
| Pilot Studies* |
| Program Office Staff |
| Study investigators (CC and Study Centers) |
* Findings on website: nationalchildrensstudy.gov
Hypothesis Based Priority Health Outcomes/Exposures
| Priority Health Outcomes | Examples |
| Pregnancy Outcomes | Preterm, Birth defects |
| Neurodevelopment & Behavior | Autism, learning disabilities, schizophrenia, conduct and behavior problems |
| Injury | Head trauma, Injuries requiring hospitalizations |
| Asthma | Asthma incidence and exacerbation |
| Obesity & Physical Development | Obesity,diabetes, altered puberty |
| Priority Exposures | Examples |
| Physical Environment | Housing quality, neighborhood |
| Chemical Exposures | Pesticides, phthalates, heavy metals |
| Biologic Environment | Infectious agents, endotoxins, diet |
| Genetics | Interaction between genes and environment |
| Psychosocial milieu | Family structure, socio-economic status, parenting style, social networks, exposure to media and violence |
Sampling and Center strategies National probability sample important
Exposure-outcome relationship representative of the U.S. population Important exposures with varied and unknown distributions are not missed Clustered for community attributes & logistics Centers of excellence important
Broad scientific input Measures require center based expertise and facilities Probability sample by Centers
Unique combination Requires flexibility and adaptation of center to the scientific design Requires support and guidance by coordinating center
National Children’s Study Sample
All Births in the Nation Sample of Study Locations Sample of Study Segments Sample of Study Households Sample of Study Women
105 Locations Selection of neighborhoods All or a sample of households within neighborhoods All eligible women in the household ~4 million births in 3,141 counties
Most study locations correspond to a single county Six of the ninety-six locations include more than one county due to the small number of anticipated births in these areas
Awarded Locations (not active)
2008-2010 Locations
2007 Locations (active)
Vanguard Locations (active)
Map Legend
March 2008
National Children’s Study Locations
Locations vs. Centers Sites—geographic locations (counties) from which participants will be recruited
Selected by stratified probability sample of primary sampling units 105 Locations Centers—entities or institutions that will carry out Study at the Locations
Selected by a competitive process Each will cover more than one site 30-50 Centers
Why a contract mechanism?
| To assure a consistent rigorous core protocol carried out at all sites |
| To assure NCS addresses goals of funding agencies |
Contract Cooperative Agreement Grant
NCS
Control Independence
Study Organization:
Key Entities
| Interagency Coordinating Committee (ICC) – Senior staff and scientists of supporting Federal Agencies: – Federal oversight |
| Federal Consortium – Representatives of Federal Agencies – Broad Federal input |
| National Children’s Study Advisory Committee (NCSAC) – Review and advice |
| Program Office (PO) at NICHD – Day-to-day scientific and operational management |
| Steering Committee – Center PI’s and Federal scientists – Primary scientific deliberations |
| Coordinating Center – Data management and clinical coordination |
| Data safety monitoring committee – monitor data and advise on interventions based on findings |
Steering Committee Roles and responsibilities Identifying problems and best practices that arise in the conduct of the study Scientific input/expertise to support decision-making Making recommendations regarding scientific content of a study component Review and approval (not the only) regarding adjunct/add-on studies Decision-making about non-direction changing (and budget neutral) issues related to the protocol and MOP Proposing changes to the protocol
Study Components In place
Scientific support reviews, analyses, surveys Information technology development Contractor (BAH, CC/Westat) Clinical/data Coordinating Center (CC) Initial/Vanguard Study Centers (7) Wave I Study Locations (33) and Study Centers (24) Over this year - 2008
Wave II Study Locations (30+/-) and assoc. Centers Following – 2009+
Specimen Repository Laboratory services (NCEH, EPA, contracts) Remaining Study Locations and Center
Access to Data and Publication
| Maximum use and publication will be a guiding principle. |
| Primary hypotheses and analyses - Data access and analyses through Center PI’s and other participating investigators (including Federal Agency Scientists) |
| Publication Sub-committees of the Steering Committee for policies and oversight regarding publications. |
| Data Use and Confidentiality Protections Committee for access to data, public use and disclosure review |
| Specimen Oversight Committee as guardian for use of valuable biospecimens |
| Public use datasets to be available with each phase as per NIH guidelines, by confidentiality requirements. |
| Federal statutes and contractual agreements will prevail. |
Adjunct studies
| Involve a portion of the sample using some NCS infrastructure and data to address additional or in-depth question |
| Funding: R-01 or other grant, Public-private partnerships (foundation, industry, other), NCS |
| Process for review and approvals established at NCS Program Office |
| Examples |
Genomic analysis of subgroup specimens for targeted gene-environment interactions Functional neuro-imaging of exposed subgroup for mechanism of effect on child development Adjunct study proposals are NOT a requirement for this solicitation
Study Milestones and Timeline 2000-present Planning, Pilot studies/methods development 2005 Awarded initial contracts (Coordinating and Vanguard Centers) 2007 Congress appropriated $69 M 2007 Completion of the first phase of the pilot Study protocol 2007 Award Wave I Study Center contracts 2008 Congress appropriated $110.9 M 2008+ Reviews and approvals (OMB, Peer review, IRB’s) 2008-09* Additional Center and Location procurements (wave 2&3) 2008-09*^ Begin pilot cohort at VCs 2008-09* Repository and Laboratory procurements 2010*^ Begin full study for Wave I Locations 2011* First Study results become available (methods, pilots, preliminary findings) 2016 Full data set for outcomes of pregnancy
* Pending funding ^ Pending OMB
Thank You Next Ruth Brenner Director for Study Centers
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