Journal Article

Methodology for Clinical Trials Involving Patients with Cancer Who Have Febrile Neutropenia: Updated Guidelines of the Immunocompromised Host Society/Multinational Association for Supportive Care in Cancer, with Emphasis on Outpatient Studies

Ronald Feld, Marianne Paesmans, Alison G. Freifeld, Jean Klastersky, Philip A. Pizzo, Kenneth V. I. Rolston, Edward Rubenstein, James A. Talcott and Thomas J. Walsh

in Clinical Infectious Diseases

Published on behalf of Infectious Diseases Society of America

Volume 35, issue 12, pages 1463-1468
Published in print December 2002 | ISSN: 1058-4838
Published online December 2002 | e-ISSN: 1537-6591 | DOI: https://dx.doi.org/10.1086/344650
Methodology for Clinical Trials Involving Patients with Cancer Who Have Febrile Neutropenia: Updated Guidelines of the Immunocompromised Host Society/Multinational Association for Supportive Care in Cancer, with Emphasis on Outpatient Studies

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Two multinational organizations, the Immunocompromised Host Society and the Multinational Association for Supportive Care in Cancer, have produced for investigators and regulatory bodies a set of guidelines on methodology for clinical trials involving patients with febrile neutropenia. The guidelines suggest that response (i.e., success of initial empirical antibiotic therapy without any modification) be determined at 72 h and again on day 5, and the reasons for modification should be stated. Blinding and stratification are to be encouraged, as should statistical consideration of trials specifically designed for showing equivalence. Patients enrolled in outpatient studies should be selected by use of a validated risk model, and patients should be carefully monitored after discharge from the hospital. Response and safety parameters should be recorded along with readmission rates. If studies use these guidelines, comparisons between studies will be simpler and will lead to further improvements in patient therapy.

Journal Article.  4180 words.  Illustrated.

Subjects: Infectious Diseases ; Immunology ; Public Health and Epidemiology ; Microbiology

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