Time‐to‐event surrogate end‐points in multiple myeloma randomised trials from 2005 to 2019: a surrogacy analysis

T Etekal, K Koehn, DW Sborov… - British journal of …, 2023 - Wiley Online Library
Use of surrogate end‐points such as progression‐free survival (PFS) and other time‐to‐
event (TTE) end‐points is common in multiple myeloma (MM) clinical trials. This systematic …

Reporting of post-protocol therapies in metastatic breast cancer registration clinical trials: A systematic review

SS Shachar, Y Korzets, D Shepshelovich… - Cancer Treatment …, 2024 - Elsevier
Background As the treatment for metastatic breast cancer (MBC) often includes sequential
lines of therapy, data on post-protocol treatment in clinical trials are valuable in the …

Post-progression treatment in cancer randomized trials: a cross-sectional study of trials leading to FDA approval and published trials between 2018 and 2020

T Olivier, A Haslam, V Prasad - BMC cancer, 2023 - Springer
Background Suboptimal treatment upon progression may affect overall survival (OS) results
in oncology randomized controlled trials (RCTs). We aim to assess the proportion of trials …

Impact of treatment sequencing on overall survival in patients with transplant-ineligible newly diagnosed myeloma

R Fonseca, T Facon, M Hashim, S Nair, J He… - The …, 2023 - academic.oup.com
Background Because patients with newly diagnosed multiple myeloma (NDMM) do not
always receive any treatment beyond first-line (1L) therapy, it is imperative that patients …

Participant recruitment from low-and middle-income countries for pivotal trials of drugs approved by the US Food and Drug Administration: a cross-sectional analysis

FA Awan, AB Becker, Y Wang… - Annals of Internal …, 2022 - acpjournals.org
Background: Many participants in clinical trials supporting US Food and Drug Administration
(FDA) drug approvals are recruited from outside the United States, including from low-and …

[PDF][PDF] Ensuring ethical postprogression therapy for patients in randomized trial control arms

ERS Cliff, AS Kesselheim… - Journal of Clinical …, 2023 - drive.google.com
The ethical permissibility of randomized controlled trials (RCTs) depends on clinical
equipoise at the time of trial enrollment—the existence of uncertainty about which treatment …

Treatment attrition rates and relevant risk factors in multiple myeloma: A real-world study in China

W Tang, J Yang, Y Li, L Zhang, H Li, J Wang… - Frontiers in …, 2023 - frontiersin.org
Background: For multiple myeloma (MM), the proportions of patients reaching the
subsequent line of therapy (LOT) decline gradually and real-world data describing the …

Overall survival as a primary end point in multiple myeloma trials

ERS Cliff, GR Mohyuddin - Nature Reviews Clinical Oncology, 2022 - nature.com
Median overall survival for patients with newly diagnosed multiple myeloma may surpass
ten years. Nonetheless, many patients face considerable treatment-related morbidity and …

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 …

The lifecycle and evolution of new regimens on the National Comprehensive Cancer Network Guidelines for newly diagnosed multiple myeloma

GR Mohyuddin, J Almasri, A Goodman… - The …, 2024 - academic.oup.com
Introduction Prior studies have evaluated the level of evidence behind treatment options
listed in the National Comprehensive Cancer Network (NCCN) guidelines, but no study has …