Results for 'RCT''
Browse oncology articles matching RCT' — expert analysis, clinical perspectives, and industry updates from across drug development and care delivery. Use the tabs above for podcasts, press releases, partners, and people for the same search.
J. Mulder, S. Teerenstra, P. B. van Hennik, A. M. G. Pasmooij, V. Stoyanova-Beninska, E. E. Voest & A. de Boer
Single-arm trials supporting the approval of anticancer medicinal products in the European Union: contextualization of trial results and observed clinical benefit
single-arm trials, anticancer medicinal products, EU, trial, SAT's, oncology, European Medicines Agency, clinical benefit, contextualization
Between 2012 and 2021, 18 anticancer medicinal products for solid tumors were approved in the EU based on 21 SATs (single-arm trials). Pivotal SAT-based applications often included additional information for contextualization, such as supportive studies and external evidence. Thresholds for…
Apr 11th • 14 mins read
Marc Clausen MA, Chloe Mighton MS, Ruhi Kiflen MPH, Agnes Sebastian MSc, Wei Fang Dai MPH, Rebecca E. Mercer PhD, Jaclyn M. Beca MSc, Wanrudee Isaranuwatchai PhD, Kelvin K.W. Chan MD PhD, Yvonne Bombard PhD
Use of real-world evidence in cancer drug funding decisions in Canada: a qualitative study of stakeholders’ perspectives
RWE, RCT's, Canada, drug funding, Canadian Real-World Evidence, Data
The study emphasizes the need for a cultural shift, enhanced data infrastructure, investment in capacity building, and stakeholder collaboration for effective use of Real-World Evidence (RWE) in drug funding decisions. Cancer drug costs are escalating, with some offering substantial benefit…
Nov 4th • 12 mins read
Alfredo Addeo, MD; Glen J. Weiss, MD, MBA; Bishal Gyawali, MD, PhD
Association of Industry and Academic Sponsorship With Negative Phase 3 Oncology Trials and Reported Outcomes on Participant Survival: A Pooled Analysis
pooled analysis, FDA, negative phase 3 trials, phase 3 trial, RCT, PRISMA, RCT's
In this study of trials published in 2016 through 2018, approximately 40% of negative phase 3 RCTs in oncology were conducted without supporting phase 2 trials, and such phase 3 trials were sponsored by both academia and industry. On the basis of our results, proactive steps from regulators and ethi…
May 10th • 8 mins read
MAXIMILIAN SALCHER-KONRAD, HUSEYIN NACI, COURTNEY DAVIS
Approval of Cancer Drugs With Uncertain Therapeutic Value: A Comparison of Regulatory Decisions in Europe and the United States
pharmaceutical regulation, US Food and Drug Administration, European Medicines Agency, cancer.
Regulatory agencies often have limited evidence on the clinical benefits and harms of new drugs at the time of market approval. There is frequent discordance between the FDA and EMA in regulatory outcomes and the use of special regulatory pathways for cancer drugs of uncertain therapeutic value. …
Oct 6th • 48 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