Results for 'quality randomized studies'
Adela Rodriguez, Francis Esposito, Helena Oliveres, Ferran Torres and Joan Maurel
Are Quality of Randomized Clinical Trials and ESMO-Magnitude of Clinical Benefit Scale Two Sides of the Same Coin, to Grade Recommendations for Drug Approval?
quality randomized studies, ESMO-MCBS, drug approval
The approval of new cancer drugs by the FDA and EMA is primarily based on positive results from well-designed randomized phase III clinical trials (RCTs). Not all RCTs are analyzed to support drug approval recommendations, highlighting the need for scales to evaluate RCT quality and clinical…
Feb 11th • 3 mins read
Fei Liang, Sheng Zhang, Qin Wang, Wenfeng Li
Clinical benefit of immune checkpoint inhibitors approved by US Food and Drug Administration
Randomized trials, Clinical benefits, Immune checkpoint inhibitors, Cancer, Food and drug administration agency
The study evaluates the clinical benefits of immune checkpoint inhibitors using the ESMO-MCBS and ASCO VF scales. 18 indications for these inhibitors were approved based on RCTs conducted between 2011 and 2018. All indications meet the ESMO-MCBS 1.1 threshold for meaningful bene…
Aug 31st • 16 mins read
Talal Hilal, MD; Mohamad Bassam Sonbol, MD; Vinay Prasad, MD, MPH
Analysis of Control Arm Quality in Randomized Clinical Trials Leading to Anticancer Drug Approval by the US Food and Drug Administration
RCTs, FDA, clinical trials, anticancer, suboptimal control arms
The aim of our analysis was to evaluate the quality of control arms in RCTs leading to anticancer drug approvals by the FDA. We found that, between January 1, 2013, and July 31, 2018, FDA approval of 16 (17%) of 95 anticancer drugs for the market were based on RCTs with sub-optim…
May 2nd • 15 mins read
Muneera Al Hussain
Comment on: Oncology research in Saudi Arabia over a 10-year period. A synopsis
oncology research, saudi arabia
An article in the Saudi Medical Journal by Alghamdi et al reported on oncology research progress in Saudi Arabia. The study compared research quantity and quality between two periods: 2008-2012 and 2013-2017. There was an increase in the amount of research over time, but quality and scienti…
Jun 24th • 3 mins read
Emerson Y. Chen, MD, Vikram Raghunathan, MD, Vinay Prasad, MD, MPH
An Overview of Cancer Drugs Approved by the US Food and Drug Administration Based on the Surrogate End Point of Response Rate
FDA, RR, drug approvels, OS
Many cancer drugs come to market based on single-arm studies with modest RRs. Most of these drugs are tested in studies of over 100 patients prior to approval. Most (60%) of these approvals lack randomized clinical trials during the life cycle of the product. Our findings suggest greater room for th…
May 28th • 5 mins read
Envision Pharma Group
AI-powered real-world evidence: Strategically enhancing value and access
Oncology, Clinical Development, Targeted Therapy, Immunotherapy, Genomic Profiling, CAR-T Cell Therapy, Precision Medicine
Real-world evidence (RWE) complements traditional randomized controlled trials by providing insights from diverse data sources, helping healthcare decision-makers with coverage, reimbursement, and treatment guidelines. Artificial intelligence (AI) and natural language processing (NLP) are pivotal…
Aug 22nd • 5 mins read