Real-world data: towards achieving the achievable in cancer care

CM Booth, S Karim, WJ Mackillop - Nature reviews Clinical oncology, 2019 - nature.com
The use of data from the real world to address clinical and policy-relevant questions that
cannot be answered using data from clinical trials is garnering increased interest. Indeed …

[HTML][HTML] Characterisation and management of dermatologic adverse events to agents targeting the PD-1 receptor

VR Belum, B Benhuri, MA Postow, MD Hellmann… - European journal of …, 2016 - Elsevier
Abstract Background Dermatologic adverse events (AEs) are some of the most frequently
observed toxicities of immune-checkpoint inhibitor therapy, but they have received little …

Evolution of the randomized clinical trial in the era of precision oncology

JC Del Paggio, JS Berry, WM Hopman… - JAMA …, 2021 - jamanetwork.com
Importance The randomized clinical trial (RCT) in oncology has evolved since its
widespread adoption in the 1970s. In recent years, concerns have emerged regarding the …

Clinical and economic burden of adverse drug reactions

J Sultana, P Cutroneo, G Trifirò - Journal of Pharmacology …, 2013 - journals.sagepub.com
Adverse drug reactions (ADRs) are unwanted drug effects that have considerable economic
as well as clinical costs as they often lead to hospital admission, prolongation of hospital …

Randomised controlled trials and population-based observational research: partners in the evolution of medical evidence

CM Booth, IF Tannock - British journal of cancer, 2014 - nature.com
Recent reports have highlighted the distinct roles and occasional tension between
randomised controlled trials (RCTs) and population-based observational research (Concato …

Aflibercept versus placebo in combination with docetaxel and prednisone for treatment of men with metastatic castration-resistant prostate cancer (VENICE): a phase 3 …

IF Tannock, K Fizazi, S Ivanov, CT Karlsson… - The lancet …, 2013 - thelancet.com
Background Docetaxel plus prednisone is standard first-line chemotherapy for men with
metastatic castrate-resistant prostate cancer. Aflibercept is a recombinant human fusion …

[HTML][HTML] A systematic review of immune-related adverse event reporting in clinical trials of immune checkpoint inhibitors

TW Chen, AR Razak, PL Bedard, LL Siu, AR Hansen - Annals of Oncology, 2015 - Elsevier
Background There are limited data about the quality of immune-related adverse event (irAE)
reporting in immune checkpoint inhibitor (ICI) clinical trial publications. Methods A …

Outcomes and endpoints in trials of cancer treatment: the past, present, and future

MK Wilson, K Karakasis, AM Oza - The Lancet Oncology, 2015 - thelancet.com
Cancer treatment should allow patients to live better or longer lives, and ideally, both. Trial
endpoints should show clinically meaningful improvements in patient survival or quality of …

Hepatotoxicity of tyrosine kinase inhibitors: clinical and regulatory perspectives

RR Shah, J Morganroth, DR Shah - Drug safety, 2013 - Springer
The introduction of small-molecule tyrosine kinase inhibitors (TKIs) in clinical oncology has
transformed the treatment of certain forms of cancers. As of 31 March 2013, 18 such agents …

Ponatinib drives cardiotoxicity by S100A8/A9-NLRP3-IL-1β mediated inflammation

S Tousif, AP Singh, P Umbarkar, C Galindo… - Circulation …, 2023 - Am Heart Assoc
Background: The tyrosine kinase inhibitor ponatinib is the only treatment option for chronic
myelogenous leukemia patients with T315I (gatekeeper) mutation. Pharmacovigilance …