[HTML][HTML] Biases in study design, implementation, and data analysis that distort the appraisal of clinical benefit and ESMO-Magnitude of Clinical Benefit Scale (ESMO …

B Gyawali, EGE De Vries, U Dafni, T Amaral, J Barriuso… - ESMO open, 2021 - Elsevier
Background The European Society for Medical Oncology-Magnitude of Clinical Benefit
Scale (ESMO-MCBS) is a validated, widely used tool developed to score the clinical benefit …

The tyranny of non-inferiority trials

IF Tannock, M Buyse, M De Backer, H Earl… - The Lancet …, 2024 - thelancet.com
Opportunities to decrease the toxicity and cost of approved treatment regimens with lower
dose, less frequent, or shorter duration alternative regimens have been limited by the …

Association of quality-of-life outcomes in cancer drug trials with survival outcomes and drug class

JN Samuel, CM Booth, E Eisenhauer… - JAMA …, 2022 - jamanetwork.com
Importance Although quality of life (QOL) is an important clinical end point, cancer drugs are
often approved based on overall survival (OS) or putative surrogate end points such as …

Near-equivalence: generating evidence to support alternative cost-effective treatments

IF Tannock, MJ Ratain, DA Goldstein… - Journal of Clinical …, 2021 - ascopubs.org
The cost of cancer drugs is a challenge to patients and healthcare systems. Here, we
propose a new paradigm of near-equivalence, which combines various types of evidence to …

Alternative trastuzumab dosing schedules are associated with reductions in health care greenhouse gas emissions

SI Jacobson, AJ Kacew, RW Knoebel… - JCO Oncology …, 2023 - ascopubs.org
PURPOSE Cancer care–related greenhouse gas (GHG) emissions harm human health.
Many cancer drugs are administered at greater-than-necessary doses, frequencies, and …

Normative growth charts for Shwachman-Diamond syndrome from Italian cohort of 0–8 years old

M Cipolli, G Tridello, A Micheletto, S Perobelli… - BMJ open, 2019 - bmjopen.bmj.com
Objectives Shwachman-Diamond syndrome (SDS) is a rare autosomal recessive disorder.
Its predominant manifestations include exocrine pancreatic insufficiency, bone marrow …

Justification, margin values, and analysis populations for oncologic noninferiority and equivalence trials: a meta-epidemiological study

TJ Kleber, AD Sherry, AJ Arifin… - JNCI: Journal of the …, 2024 - academic.oup.com
Background Noninferiority (NI) and equivalence trials evaluate whether an experimental
therapy's effect on the primary endpoint (PEP) is contained within an acceptable margin …

[HTML][HTML] Off-label, but on target: the evidence needed to implement alternative dosing regimens of anticancer drugs

JK Overbeek, R Ter Heine, HMW Verheul, E Chatelut… - ESMO open, 2023 - Elsevier
Over the past decades, dose selection of anticancer drugs has been dictated by the
maximum tolerated dose (MTD), based on tolerability rather than efficacy. 1 Tolerability …

Evidence for stratified conflicts of interest policies in research contexts: a methodological review

SS Graham, MS Karnes, JT Jensen, N Sharma… - BMJ open, 2022 - bmjopen.bmj.com
Objectives The purpose of this study was to conduct a methodological review of research on
the effects of conflicts of interest (COIs) in research contexts. Design Methodological review …

Use of bone-modifying agents among Medicare beneficiaries with multiple myeloma

A Gupta, P Wang, SA Ali, SV Rajkumar… - JAMA …, 2020 - jamanetwork.com
Use of Bone-Modifying Agents Among Medicare Beneficiaries With Multiple Myeloma |
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