PURE

1
PURE
Argentine Current status Andres
Orlandini Dubai 2006
2
Timelines
Translations Regulatory approvals Plan the
logistics Funding searching
Importations CRF printing
Pilot
Final follow up
Interim follow up
Recruitment
2003 2004 2005 2006
2007 2008
2018 /2019
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PURE ARGENTINAPilot Study
Recruitment

• RURAL(44)
• B. Irigoyen (2,200 subjects)
• 100 km from Rosario
• Local authorities support
• 3 day work
• Data collected at a Health Care Center
• Team (1 MD, 1 biochemist, 3 Study Coordinator,
  1 nutricionist)

• URBAN(48)
• Rosario
• (1,000,000 subjects)
• 10 day work
• Data collected at IIC
• Team 4 members (1 MD, 1 Biochemist, 2 Study
  Coordinators)

4
Pilot experience

• People came alone, eventually in couples, both
  in urban and rural settings.

RURAL SAMPLE MEAN AGE MEN 50 MEAN AGE WOMEN 52
URBAN SAMPLE MEAN AGE MEN 50 MEAN AGE WOMEN 57
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Pilot experience Lessons learned

• Too long questionnaires (3 hs. to complete the
  visit)
• Rural subjects needed more assistance than
  urban subjects
• Family Census Q. Rural subjects were not able
  to provide contact person
• Adult Q. Unclear definition of ethnic origin
  

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Organizational chart
National Coordinator Rafael Diaz
ECLA A.Orlandini-E.Paolasso COM A.Pascual SC
G.Niemann
Urban
Rural (5)
Local office
IIC
PI N.Maldonado Nut S.Del Cerro Nurse Data entry
Local Physician Nurse
Field workers 2 supervisors 5 assistants
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Pure full scaleUrban

• City Rosario
• Center Instituto de Investigaciones Clinicas
• Population 1.011.642 habitants
• Area 117 km2
• Blocks 6.306

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Pure full scaleUrban

• a) 3 neighborhoods
• Middle class Echesortu 3300 households
• High class Martin 1100 households
• Low class JJ Paso 1200 households

• b) local industry
• Paladini SA
• 1380 employers (Villa Gobernador Galves)
• 80 men
• Age 18-65 (x32)

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Pure full scaleRural

• Santa Fe State
• 5 villages
• Less than 2000 inhabitants (definition of rural
  in Argentina)
• Between 50 and 100 km from Rosario

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Logistics
Urban
Rural
Census
Census
2 subjects
3 subjects

• IIC
• Icon
• PE and Q
• Blood sample collection
• (-) 70 storage

• Local offices
• Icon
• PE and Q
• Blood sample collection
• and processing

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Pure full scaleFunding

• Support for local private companies (50.000 US)
  have been already obtained
• Additional support is being searched