Unique roles of a data and safety monitoring board in vaccine safety trials with compressed timelines and urgent implications

Controlled Clinical Trials

Volumn 24, Issue 1, 2003, Pages 99-104

  Scheifele, David ^a,c   Duval, Bernard ^b   De Serres, Gaston ^b   Skowronski, Danuta M ^a  

^a Canadian Assoc for I R/E (CAIRE)   (Canada)

^b Canadian Assoc for I R/E (CAIRE)   (Canada)

^c BC CHILDREN S HOSPITAL   (Canada)

Author keywords

Immunization; Influenza vaccine; Randomized controlled trials; Research personnel

Indexed keywords

INFLUENZA VACCINE; PLACEBO;

ARTICLE; CANADA; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DATA ANALYSIS; DOUBLE BLIND PROCEDURE; DRUG SAFETY; HEALTH PROGRAM; HUMAN; INFLUENZA; INFLUENZA VACCINATION; MAJOR CLINICAL STUDY; METHODOLOGY; MONITORING; MULTICENTER STUDY; PLANNING; POLICY; PROFESSIONAL STANDARD; RANDOMIZED CONTROLLED TRIAL;

CANADA; CLINICAL TRIALS DATA MONITORING COMMITTEES; DATA INTERPRETATION, STATISTICAL; HUMANS; INFLUENZA VACCINES; PUBLIC POLICY; RANDOMIZED CONTROLLED TRIALS; RESEARCH DESIGN; TIME FACTORS;

EID: 12244256089     PISSN: 01972456     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0197-2456(02)00269-6     Document Type: Article

References (6)

1. Boulianne N., De Serres G., Duval B., Shadmani R., Rochette L. Clinical manifestations and incidence of oculorespiratory syndrome following influenza vaccination - Quebec, 2000. Can Commun Dis Rep. 27:2001;85-90.
2. National Advisory Committee on Immunization. Supplementary statement for the 2001-2002 season. influenza vaccination of persons who experienced oculorespiratory syndrome following previous influenza vaccination Can Commun Dis Rep. 27:2001;1-7. [Advisory Committee Statement-7].
3. National Advisory Committee on Immunization. Supplementary statement for the 2002-2003 influenza season. update on oculorespiratory syndrome in association with influenza vaccination Can Commun Dis Rep. 28:2002;1-8. [Advisory Committee Statement-6].
4. Greenland S., Robbins J.M. Conceptual problems in the definition and interpretation of attributable fraction. Am J Epidemiol. 128:1988;1185-1197.
5. Scheifele DW, Duval B, Russell M, et al. Oculorespiratory syndrome (ORS) among healthy adults given a reformulated influenza vaccine previously linked with ORS (abstract). Fifth Annual Conference on Vaccine Research, Baltimore, Maryland. Abstract S43, 2002.
6. Skowronski DM, De Serres G, Warrington R, et al. Oculo-respiratory syndrome following influenza vaccine: recurrence risk with re-formulated vaccine for 2001-2002 (abstract). Fifth Annual Conference on Vaccine Research, Baltimore, Maryland. Abstract S42, 2002.