The Benefits and Risks of Receiving Investigational Solid Tumor Drugs in Randomized Trials: A Systematic Review and Meta-analysis

R Iskander, H Moyer, D Fergusson… - Annals of Internal …, 2024 - acpjournals.org
Background: Many patients participate in cancer trials to access new therapies. The extent to
which new treatments produce clinical benefit for trial participants is unclear. Purpose: To …

Reporting of adverse events of treatment interventions in multiple myeloma: an overview of systematic reviews

M Mainou, KI Bougioukas, K Malandris, A Liakos… - Annals of …, 2024 - Springer
The present study is an overview of systematic reviews focusing on adverse events of
antimyeloma treatments. It provides a systematic description of adverse events as they are …

[HTML][HTML] The approval and withdrawal of melphalan flufenamide (melflufen): Implications for the state of the FDA.

T Olivier, V Prasad - Translational Oncology, 2022 - Elsevier
In October 2021, melphalan flufenamide (melflufen) was withdrawn from the US market for
the treatment of multiple myeloma. The decision occurred based on results from a phase 3 …

Use of suboptimal control arms in randomized clinical trials of investigational cancer drugs in China, 2016–2021: An observational study

Y Zhang, D Chen, S Cheng, Z Liang, L Yang, Q Li… - PLoS …, 2023 - journals.plos.org
Background The use of suboptimal controls in randomized trials of new cancer drugs can
produce potentially unreliable clinical efficacy results over the current standard of care and …

[HTML][HTML] Randomised controlled trials evaluating anticancer therapies in haematological cancers: an overview of global research activity

M Sengar, WM Hopman, GR Mohyuddin… - …, 2023 - ncbi.nlm.nih.gov
Background Design, results, and interpretation of oncology randomised controlled trials
(RCTs) have changed substantially over the past decade. In this study, we describe all RCTs …

Control Groups in RCTs Supporting Approval of Drugs for Systemic Rheumatic Diseases, 2012-2022

Y Liu, Y Xie, Y Qin, Q Xie, X Chen - JAMA Network Open, 2023 - jamanetwork.com
Importance Randomized clinical trials (RCTs) testing innovative drugs must strive to use
optimal control groups to reflect the best available treatments. A comprehensive evaluation …

Control participants of randomised trials: an often forgotten, vulnerable population

GR Mohyuddin, N Mehra, B Ryll… - The Lancet Haematology, 2022 - thelancet.com
A lot of attention is rightfully given to racial and socioeconomic disparities in cancer care. 1 It
is certain that disadvantaged groups have less access to lifeextending oncology care, with …

Post-protocol therapy and informative censoring in the CANDOR study

T Meirson, G Markel, V Prasad, AM Goodman… - The Lancet …, 2022 - thelancet.com
We read with great interest and wish to congratulate Saad Z Usmani and colleagues on the
CANDOR study comparing carfilzomib, dexamethasone, and daratumumab (KdD) with …

Utilising Health Technology Assessment to Develop Managed Access Protocols to Facilitate Drug Reimbursement in Ireland

C Gorry, M Daly, R Barrett, K Finnigan, A Smith… - … health economics and …, 2024 - Springer
Abstract The Health Service Executive, responsible for operating the Irish health service, has
introduced health technology management (HTM) initiatives to manage expenditure on …

Multiple myeloma: challenges with deciding the optimal sequencing strategy

A Walia, A Haslam, J Tuia, V Prasad - Frontiers in Pharmacology, 2023 - frontiersin.org
The therapeutic landscape for multiple myeloma (MM) has witnessed great advances over
the past two decades, with more than 20 FDA-approved drugs currently available. The latest …