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Utilization of real-world data in assessing treatment effectiveness for diffuse large B-cell lymphoma.
Nowakowski, Grzegorz; Maurer, Matthew J; Cerhan, James R; Dey, Debarshi; Sehn, Laurie H.
Afiliação
  • Nowakowski G; Division of Hematology, Mayo Clinic, Rochester, Minnesota, USA.
  • Maurer MJ; Division of Hematology, Mayo Clinic, Rochester, Minnesota, USA.
  • Cerhan JR; Department of Quantitative Health Sciences, Mayo Clinic, Rochester, Minnesota, USA.
  • Dey D; MorphoSys AG, Planegg, Germany.
  • Sehn LH; BC Cancer Centre for Lymphoid Cancer and the University of British Columbia, Vancouver, Canada.
Am J Hematol ; 98(1): 180-192, 2023 01.
Article em En | MEDLINE | ID: mdl-36251361
Direct comparisons of the effectiveness of the numerous novel therapies in the diffuse large B-cell lymphoma (DLBCL) treatment landscape in a range of head-to-head randomized phase 3 trials would be time-consuming and costly. Comparative effectiveness studies using real-world data (RWD) represent a complementary approach. Recently, several studies of relapsed/refractory (R/R) DLBCL have used RWD to create observational cohorts to compare patient outcomes with cohorts derived from single-arm phase 2 trials. Using propensity score methods to balance clinically and prognostically relevant baseline covariates, closely matched patient-level cohorts can be generated. By incorporating appropriate measures to assess covariate balance and address potential bias in comparative effectiveness study designs, robust comparative analyses can be performed. Results from such studies have been used to supplement regulatory approval of therapies assessed in single-arm trials. While RWD studies have a greater susceptibility to bias compared to randomized controlled trials, well-designed and appropriately analyzed studies can provide complementary real-world evidence on treatment effectiveness.
Assuntos

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Linfoma não Hodgkin / Linfoma Difuso de Grandes Células B Tipo de estudo: Clinical_trials / Prognostic_studies Limite: Humans Idioma: En Ano de publicação: 2023 Tipo de documento: Article

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Linfoma não Hodgkin / Linfoma Difuso de Grandes Células B Tipo de estudo: Clinical_trials / Prognostic_studies Limite: Humans Idioma: En Ano de publicação: 2023 Tipo de documento: Article