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Reporting of adverse event data in hematopoietic stem cell transplantation clinical trials involving investigational new drugs or devices: a report from the William Guy Forbeck Foundation 2001 focus meeting on clinical trials in hematopoietic stem cell transplantation. Biol Blood Marrow Transplant 2002;8(6):295-302 PMID: 12108915

Pubmed ID

12108915

Abstract

The William Guy Forbeck Foundation was established in 1984 in memory of William Guy Forbeck, an 11-year-old boy who died of neuroblastoma. The objectives of the Forbeck Foundation are to promote advances and shorten the research timetable in the field of oncology, particularly pediatric oncology. The Foundation's centerpiece activity is an annual scientific forum held at Hilton Head Island, South Carolina, where 12 to 15 leading scientists from a variety of disciplines associated with a specific topic are invited to participate in a private "think tank" environment, where they can freely exchange ideas in the hope of building on each other's knowledge and experience. Additionally, the Foundation sponsors grants for Focus Meetings, which are designed to give other researchers an opportunity to conduct their own meetings along the lines of the Foundation's annual forum. The idea for this Focus Meeting was born during the 2000 Annual Forbeck Forum in South Carolina, which considered the current status of allogeneic hematopoietic stem cell transplantation (HSCT). Participants considered various obstacles to conducting clinical trials in this area and decided to bring together experts from academia, industry, and government to discuss ways in which these obstacles might be overcome. Topics included efficient clinical trial designs, issues of monitoring and reporting adverse events, and appropriate definitions and grading systems for transplantation-specific outcomes. This article summarizes the issue of adverse event reporting in HSCT.

Author List

Martin PJ, Antin JH, Weisdorf DJ, Paton V, Horowitz MM

Author

Mary M. Horowitz MD, MS Center Director, Professor in the Medicine department at Medical College of Wisconsin




Scopus

2-s2.0-0036063859   8 Citations

MESH terms used to index this publication - Major topics in bold

Adult
Adverse Drug Reaction Reporting Systems
Clinical Trials as Topic
Government Regulation
Guidelines as Topic
Hematopoietic Stem Cell Transplantation
Humans
Male
jenkins-FCD Prod-332 f92a19b0ec5e8e1eff783fac390ec127e367c2b5