title: Unique roles of a data and safety monitoring board in vaccine safety trials with compressed timelines and urgent implications.
abstract: Studies with urgent implications for public policy and programs represent a special case for monitoring boards, whose responsibilities must include ensuring applicability to policy making and timely communication of results as well as data and safety monitoring. We recently conducted two preseason evaluations of an influenza vaccine, results of which would influence the supply of vaccine for the Canadian annual program. Only 12 weeks were available for planning the studies and 6 weeks for fieldwork and data analysis. The enlisted board played key roles in determining appropriate study design, setting and enforcing rules for study initiation and early termination, monitoring safety, and encouraging timely dissemination of results. An extended role in data monitoring would have been desirable. Providing a safety valve for inevitable tensions between investigators and sponsor was an understated but significant role. Lessons from our experience will be particularly pertinent to future studies of pandemic influenza vaccines.
authors.affiliation: Canadian Association for Immunization Research and Evaluation, Vancouver, British Columbia, Canada. dscheifele@cw.bc.ca
authors.forename: David
authors.initials: D
authors.lastname: Scheifele
authors.forename: Bernard
authors.initials: B
authors.lastname: Duval
authors.forename: Gaston
authors.initials: G
authors.lastname: De Serres
authors.forename: Danuta M
authors.initials: DM
authors.lastname: Skowronski
mesh_terms: D002170:Canada; D026661:Clinical Trials Data Monitoring Committees / Q000458:organization & administration*; D003627:Data Interpretation, Statistical; D006801:Humans; D007252:Influenza Vaccines / Q000627:therapeutic use*; D011640:Public Policy; D016032:Randomized Controlled Trials as Topic / Q000592:standards*; D012107:Research Design; D013997:Time Factors
chemical_list: D007252:Influenza Vaccines