PURE Argentine Current status Andres Orlandini Dubai 2006.

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Presentation transcript:

PURE Argentine Current status Andres Orlandini Dubai 2006

Timelines Pilot Translations Regulatory approvals Plan the logistics Funding searching /2019 Importations CRF printing Recruitment Final follow upInterim follow up

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

Pilot experience People came alone, eventually in couples, both in urban and rural settings. URBAN SAMPLE MEAN AGE MEN: 50 MEAN AGE WOMEN: 57 RURAL SAMPLE MEAN AGE MEN: 50 MEAN AGE WOMEN: 52

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

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

Pure full scale Urban City: Rosario Center: Instituto de Investigaciones Clinicas Population: habitants Area:117 km2 Blocks: 6.306

Pure full scale Urban a) 3 neighborhoods –Middle classEchesortu3300 households –High class Martin1100 households –Low class JJ Paso1200 households b) local industry –Paladini SA –1380 employers (Villa Gobernador Galves) –80 % men –Age (x32)

Pure full scale Rural Santa Fe State –5 villages –Less than 2000 inhabitants (definition of rural in Argentina) –Between 50 and 100 km from Rosario

Logistics Urban Census 2 subjects IIC Icon PE and Q Blood sample collection (-) 70 storage Rural Census 3 subjects Local offices Icon PE and Q Blood sample collection and processing

Pure full scale Funding Support for local private companies ( US$) have been already obtained Additional support is being searched