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Clinical Research Program Report

Clinical Research Program Report. INCTR Annual Meeting 2005 Melissa Adde, Director Clinical Trials Office. General Description of Program . Main Functions Coordination of Strategy Groups Management of Clinical Research Studies Serve as the Data Center for Clinical Research Studies

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Clinical Research Program Report

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  1. Clinical Research Program Report INCTR Annual Meeting 2005 Melissa Adde, Director Clinical Trials Office Annual Meeting 2005

  2. General Description of Program • Main Functions • Coordination of Strategy Groups • Management of Clinical Research Studies • Serve as the Data Center for Clinical Research Studies • Provision of Education and Training Related to Clinical Trials • Other Functions • Administration of INCTR Ethical Review Committee • Provision of Data Management Services

  3. Strategy Groups – A Brief Review • Comprised of investigators from countries with limited resources • Disease-specific (African BL, Breast Cancer, Cervical Cancer, Leukemia, Leukemia Study Group of India, Lymphoma, Osteosarcoma, Retinoblastoma) • Determine the role of INCTR in the control of a specific cancer • Design of clinical research studies

  4. On-going Clinical Research Studies • Understanding Problems Faced by Parents of Children with Retinoblastoma Prior to Treatment • The Treatment and Characterization of Acute Lymphoblastic Leukemia in Children, Adolescents and Young Adults • The Treatment and Characterization of Burkitt’s Lymphoma in Africa • A Retrospective Survey of Presentation Features of Breast Cancer and Risk Factors for Treatment Outcome

  5. Retinoblastoma Study • Survey study of parents of children with retinoblastoma (questionnaire) • Objective: • To identify the factors contributing to delays in diagnosis and obtaining treatment

  6. Retinoblastoma Study • 11 institutions from 8 countries have contributed data to this study • Brazil • Bolivia • Mexico • Nigeria • Zimbabwe • Turkey (2 institutions) • India (3 institutions) • Pakistan

  7. Retinoblastoma Study

  8. Retinoblastoma Study – Summary of Findings • Children from rural areas had higher stages of disease • Older age children had higher stages of disease • Fathers’ education level was associated with St Jude Stage of disease (the lower the education level, the higher the stage) • Lower education levels of fathers were associated with increased time intervals between detection of first symptom and diagnosis

  9. INCTR 02-04 - Objectives • Characterize the pattern of ALL in India (immunophenotype, DNA index, molecular profiling) • Correlate laboratory findings with clinical characteristics • Identify prognostic factors predictive of relapse and survival

  10. INCTR 02-04 – Total 149 Patients

  11. INCTR 02-04 Off-Study Patients

  12. INCTR 02-04 Summary • More intensive than MCP841 • Too soon to evaluate outcome differences with MCP841 • Data monitoring has been introduced • Web-based data entry has been introduced • Study committee comprised of PIs formed which is actively making protocol-related decisions

  13. INCTR 03-06 - Objectives • Characterize the presentation features of African Burkitt Lymphoma • Assess response and survival • Utilizes standard treatment (CTX, VCR, MTX and IT therapy) for Africa • Includes second-line treatment for NR or relapse patients (IFOS, ETOP, ARAC, IT therapy) • Improve data collection and patient follow-up

  14. INCTR 03-06 – Patient Characteristics

  15. INCTR 03-06 – Off-Study Patients

  16. INCTR 03-08 • Retrospective Survey of Female Breast Cancer Patients 1993-2001 • Presentation features • Treatment received • Outcome • Data retrieval is underway in 4 institutions (Peru, Egypt, India, Pakistan)

  17. Studies in Development • African Burkitt Lymphoma • Phase II Study of Depocyte (relapsed CNS disease) • Breast Cancer • Randomized study comparing two neoadjuvant approaches in the management of locally advanced breast cancer • Retinoblastoma • Treatment of extraocular retinoblastoma

  18. Reasons for Delays in Study Development • Requires Group Consensus • Takes time to achieve and compromise is necessary • Requires willingness to work in a group vs independently • Competing Local Issues • Little time to devote to protocol development and writing • Local priorities and projects can take precedence and in some cases prohibit participation • Motivation for Conducting Research Differs

  19. Education and Training in Clinical Research • Protocol-specific Data Manager Training Courses • Indian ALL Study (Nov 2004) • African BL Study (Nov 2005) • Breast Cancer Survey Study (2006) • Introduction to Basic Data Management • Manila Philippines June 2005 • Amman Jordan April 2006

  20. Thank You • PIs and Data Managers involved in on-going and completed studies • David Venzon • Paul Jarosinski • OIA and NCI Liaison Office • INCTR ERC • Julia Challinor • Lolita Lantican • Corinne Claes

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