title: A proposal for developing a large patient population cohort for longterm safety monitoring in rheumatoid arthritis. OMERACT Drug Safety Working Party.
abstract: This paper proposes the creation of an objectively acquired reference database to more accurately characterize the incidence and longterm risk of relatively infrequent, but serious, adverse events. Such a database would be maintained longitudinally to provide for ongoing comparison with new rheumatologic drug safety databases collecting the occurrences and treatments of rare events. We propose the establishment of product-specific registries to prospectively follow a cohort of patients with rheumatoid arthritis (RA) who receive newly approved therapies. In addition, a database is required of a much larger cohort of RA patients treated with multiple second line agents of sufficient size to enable case-controlled determinations of the relative incidence of rare but serious events in the treated (registry) versus the larger disease population. The number of patients necessary for agent-specific registries and a larger patient population adequate to supply a matched case-control cohort will depend upon estimates of the detectability of an increased incidence over background. We suggest a system to carry out this proposal that will involve an umbrella organization, responsible for establishment of this large patient cohort, envisioned to be drawn from around the world.
authors.affiliation: Department of Medicine, Standford Universiity, Palo Alto, CA, USA.
authors.forename: J A
authors.initials: JA
authors.lastname: Lipani
authors.forename: V
authors.initials: V
authors.lastname: Strand
authors.forename: K
authors.initials: K
authors.lastname: Johnson
authors.forename: T
authors.initials: T
authors.lastname: Woodworth
authors.forename: D
authors.initials: D
authors.lastname: Furst
authors.forename: G
authors.initials: G
authors.lastname: Singh
authors.forename: R
authors.initials: R
authors.lastname: Day
authors.forename: P
authors.initials: P
authors.lastname: Brooks
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems / Q000458:organization & administration*; D018501:Antirheumatic Agents / Q000009:adverse effects* / Q000633:toxicity*; D001172:Arthritis, Rheumatoid / Q000188:drug therapy*; D002986:Clinical Trials as Topic / Q000592:standards; D015331:Cohort Studies; D006801:Humans; D012042:Registries
chemical_list: D018501:Antirheumatic Agents