Michigan Alliance for the National Childrens Study M A N C S

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Michigan Alliance for the National Childrens
StudyM A N C S

• NIGEL PANETH MD MPH,
• PRINCIPAL INVESTIGATOR
• MICHIGAN STATE UNIVERSITY
• MARCH 25, 2008

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HISTORY OF THE NATIONAL CHILDRENS STUDY
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PL 106-310 Childrens Health Act of 2000

• The Director of NICHD shall establish a
  consortium of representatives from appropriate
  Federal agencies (including the CDC and EPA) to
• (1) plan, develop, and implement a prospective
  cohort study, from birth to adulthood, to
  evaluate the effects of both chronic and
  intermittent exposures on child health and human
  development and
• (2) investigate basic mechanisms of developmental
  disorders and environmental factors, both risk
  and protective, that influence health and
  developmental processes.

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The National Childrens Study

• Longitudinal study of a nationally representative
  sample of 100,000 children, their families, and
  their environment from before birth through age
  21.
• Largest longitudinal study of childrens health
  and development ever conducted in the U.S.
• Largest study combining all forms of
  epidemiologic measurement in depth (self-report,
  clinical examinations, biological samples) ever
  conducted on any human population.

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Why Are Large Population Longitudinal Studies So
Valuable?

• If we know what happens to people before disease
  develops, we can understand what causes disease
  and how disease can be prevented.
• The Framingham Heart Study followed healthy
  adults for many years, and taught us that factors
  such as high blood pressure, diabetes, smoking
  and high cholesterol predispose to heart disease.
  
• Applying those lessons has led to a 60 reduction
  in the heart disease death rate, a 42 reduction
  in the overall death rate, and an extra 9 years
  of life over the past 50 years in the US.
• The NCS is a Framingham study for kids

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Framingham Heart Study
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WHAT IS BEING STUDIED?
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Priority Health Exposures and Outcomes
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Data To Be Collected Before and During Pregnancy
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Data To Be Collected at Delivery And in Infancy
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So, the NCS will Provide

• Causal factors for a number of diseases and
  conditions of children.
• The answers to concerns about known exposures
  during childhood to potential toxicants
• How multiple causes interact to result in disease
  
• Identification of early life factors that
  contribute to adult conditions
• A national resource to answer future questions by
  using stored biological and environmental samples
  and the extensive data for decades to come

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SAMPLING PLAN
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National Childrens Study Sample
All Births in the Nation
4 million births in 3,141 counties
Sample of Study Locations
105 Locations
Selection of neighborhoods
Sample of Study Segments
All or a sample of households within neighborhoods
Study Households
All eligible women in the household
Study Women
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• 7 Vanguard sites
• 22 Wave 1 sites (including Wayne)
• 13 approved Wave 2 and Wave 3 sites
• 58 Wave 2 and 3 sites in current RFP

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Status of NCS Funding

• Total projected cost of study is 2.7B over 25 y
• (Human Genome 2B, WHI - 1B, over much shorter
  periods)
• FY 05 funds in the presidents budget allowed
  initiation of the announced procurements
  (vanguard centers, coordinating center)
• 69 M in FY 07 budget to initiate full study
• 110 M in FY 08 budget to add study centers
• 192 M anticipated for FY 09
• After that, should drop to around 100 M
  (probably in year 5-6 after all pregnancies are
  enrolled

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The NCS Is A Worthwhile Investment

• This year 8,000 children will be born in the US
  with cerebral palsy, whose lifetime medical,
  rehabilitative and educational care will cost
  about 10 billion dollars.
• If the NCS does nothing but find a way to reduce
  the incidence of cerebral palsy by 10 it will
  have paid for itself in 2.5 years.
• And thats without counting asthma, premature
  birth, autism, learning disorders, obesity and
  all the other costly childhood conditions that
  may be prevented by this study.

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TO LEARN MORE ABOUT THE NATIONAL CHILDRENS STUDY

• Check the Web site http//NationalChildrensStudy.
  gov
• Contact the NCS at ncs_at_mail.nih.gov

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M A N C S

• What is the Michigan Alliance for the National
  Childrens Study (MANCS)?

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Michigans 5 NCS Study Counties
Genesee Grand Traverse Lenawee Macomb Wayne
(funded in 2007)
Applying now for funding
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MANCS Participants

• Henry Ford Health System (HFHS)
• Michigan Department of Community Health (MDCH)
• Michigan State University (MSU)
• University of Michigan (UM)
• Wayne State University (WSU) Childrens Hospital
  of Michigan (CHM)
• The five selected NCS counties Genesee, Grand
  Traverse, Lenawee, Macomb, Wayne

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MANCS Timeline
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MANCS Capacity

• The four university/health system members combine
  for nearly 0.5 billion in annual NIH research
  dollars, 96 of Michigans total
• MANCS has
• The nations leading survey research center (U of
  M)
• the nations only perinatal epidemiology training
  program (MSU)
• One of the leading research OB/GYN departments in
  the nation (Wayne State)
• Two outstanding childrens hospitals

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MANCS is organized functionally by cores,
coordinated by a central study office at MSU

• 3 Population Cores
• Community Engagement (HFHS and MSU)
• Sampling, Enrollment, Maintenance (U of M)
• Vital Data (MDCH)
• 3 Clinical Cores
• Obstetric Core (WSU)
• Pediatric Core (HFHS)
• Developmental Core (U of M)
• 2 Specimen Cores
• Biological specimens (CHM)
• Environmental specimens (HFHS)

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MANCS Organization
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LEADERSHIP IN THE COUNTIES

• Each county will have a location principal
  investigator
• Genesee William Lyman PhD
• Grand Traverse Michael Collins MD MSc
• Lenawee Dan Keating PhD
• Macomb Christine Johnson PhD

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MANCS Collaboration

• The steering committee met by phone biweekly, and
  in person every three months, rotating venues
  among participating units since 2005.
• We made several trips to Washington-Bethesda
  together to attend NCS meetings and/or to lobby
  congress
• We jointly designed and funded a pilot study of
  the feasibility of NCS- type research in
  pregnancy in Kent County, MI
• When the study was announced, each institution
  took on a specific role in the study proposal

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MANCS Private-Public Partnerships

• MDCH has been a full partner since the first
  meetings. The state maternal and child
  epidemiologist is on the executive committee.
• All five counties have sent representatives to
  the steering committee usually either the
  health officer or the medical director. One
  county health officer serves on the executive
  committee.

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MANCS Research Opportunities

• We currently have a subcommittee on ancillary
  studies, and we expect interested investigators
  to develop hypotheses and ancillary studies from
  our data well into the future
• These ancillary studies are key to adding to our
  knowledge and treatment of childhood diseases,
  and the possibilities are nearly endless

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MANCS Contact Information

• MSU Nigel Paneth MD MPH paneth_at_msu.edu
• HFHS - Christine Johnson PhD cjohnso1_at_hfhs.org
• MDCH Violanda Grigorescu MD vgrigorescu_at_michigan
  .gov
• Wayne - William Lyman PhD wlyman_at_med.wayne.edu
• UM Dan Keating PhD keatingd_at_umich.edu