Utilization of real-world data in assessing treatment effectiveness for diffuse large B-cell lymphoma

Grzegorz Nowakowski; Matthew J Maurer; James R Cerhan; Debarshi Dey; Laurie H Sehn

doi:10.1002/ajh.26767

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Utilization of real-world data in assessing treatment effectiveness for diffuse large B-cell lymphoma

Journal article

Open access

Peer reviewed

Utilization of real-world data in assessing treatment effectiveness for diffuse large B-cell lymphoma

Grzegorz Nowakowski, Matthew J Maurer, James R Cerhan, Debarshi Dey and Laurie H Sehn

American journal of hematology, Vol.98(1), pp.180-192

01/2023

DOI: 10.1002/ajh.26767

PMCID: PMC10092365

PMID: 36251361

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https://doi.org/10.1002/ajh.26767View

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Abstract

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.

Humans

Lymphoma, Large B-Cell, Diffuse - drug therapy

Lymphoma, Large B-Cell, Diffuse - pathology

Lymphoma, Non-Hodgkin

Treatment Outcome

Details

Title: Subtitle: Utilization of real-world data in assessing treatment effectiveness for diffuse large B-cell lymphoma
Creators: Grzegorz Nowakowski - Division of Hematology Mayo Clinic Rochester Minnesota USA
Matthew J Maurer - Division of Hematology Mayo Clinic Rochester Minnesota USA
James R Cerhan - Mayo Clinic in Florida
Debarshi Dey - MorphoSys
Laurie H Sehn - University of British Columbia
Resource Type: Journal article
Publication Details: American journal of hematology, Vol.98(1), pp.180-192
DOI: 10.1002/ajh.26767
PMID: 36251361
PMCID: PMC10092365
ISSN: 0361-8609
eISSN: 1096-8652
Language: English
Date published: 01/2023
Academic Unit: Epidemiology
Record Identifier: 9984368207402771

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