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Titolo:
A proposal for developing a large patient population cohort for longterm safety monitoring in rheumatoid arthritis
Autore:
Lipani, JA; Strand, V; Johnson, K; Woodworth, T; Furst, D; Singh, G; Day, R; Brooks, P;
Indirizzi:
Stanford Univ, Dept Med, Palo Alto, CA USA Stanford Univ Palo Alto CA USA tanford Univ, Dept Med, Palo Alto, CA USA Pfizer Global Res, Groton, CT USA Pfizer Global Res Groton CT USAPfizer Global Res, Groton, CT USA Virginia Mason Clin, Seattle, WA 98101 USA Virginia Mason Clin Seattle WAUSA 98101 ason Clin, Seattle, WA 98101 USA Stanford Univ, Dept Med, Stanford, CA 94305 USA Stanford Univ Stanford CAUSA 94305 niv, Dept Med, Stanford, CA 94305 USA Univ New S Wales, St Vincents Hosp, Dept Clin Pharmacol, Sydney, NSW, Australia Univ New S Wales Sydney NSW Australia Pharmacol, Sydney, NSW, Australia Univ Queensland, Fac Hlth Sci, Herston, Qld, Australia Univ Queensland Herston Qld Australia Hlth Sci, Herston, Qld, Australia
Titolo Testata:
JOURNAL OF RHEUMATOLOGY
fascicolo: 5, volume: 28, anno: 2001,
pagine: 1170 - 1173
SICI:
0315-162X(200105)28:5<1170:APFDAL>2.0.ZU;2-C
Fonte:
ISI
Lingua:
ENG
Soggetto:
METHOTREXATE THERAPY; CYCLOSPORINE-A; AZATHIOPRINE; DISEASE; CANCER; MALIGNANCIES; LYMPHOMA;
Keywords:
database; surveillance; registry; adverse effects; toxicity; safety;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Clinical Medicine
Life Sciences
Citazioni:
24
Recensione:
Indirizzi per estratti:
Indirizzo: Brooks, P Royal Brisbane Hosp, Herston, Qld 4029, Australia Royal BrisbaneHosp Herston Qld Australia 4029 4029, Australia
Citazione:
J.A. Lipani et al., "A proposal for developing a large patient population cohort for longterm safety monitoring in rheumatoid arthritis", J RHEUMATOL, 28(5), 2001, pp. 1170-1173

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.

ASDD Area Sistemi Dipartimentali e Documentali, Università di Bologna, Catalogo delle riviste ed altri periodici
Documento generato il 14/07/20 alle ore 09:12:25