Results for 'real-world 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
Robbe Saesen, Georgios Kantidakis, Ann Marinus, Denis Lacombe, Isabelle Huys
How do cancer clinicians perceive real-world data and the evidence derived therefrom? Findings from an international survey of the European Organisation for Research and Treatment of Cancer
real-world evidence, real-world data, oncology, cancer, survey, clinicians, randomized controlled trials, Europe
Real-world evidence (RWE) is increasingly being used in the development and decision-making processes for anticancer therapies, but clinician views on its use are unclear. A survey conducted between May and July 2021 involved 557 clinicians from 30 countries and 13 cancer domains. Most clinician…
Aug 1st • 45 mins read
E Dawn Flick, Howard R Terebelo, Susan Fish, Amani Kitali, Vrinda Mahajan, Melissa Nifenecker, Kristen Sullivan, Paul Thaler, Sarah Ussery, David L Grinblatt
The Value of Pharmaceutical Industry-Sponsored Patient Registries in Oncology Clinical Research
registry, oncology, observational study, prospective cohort study, real-world evidence
Oncology patient registries are valuable for generating Real-World Evidence (RWE) due to: Prospective, primary data collection Characterizing smaller patient populations not typically included in clinical trials Providing insights into the rapidly changing disease course Allowing for longitudi…
Jun 7th • 8 mins read
Robbe Saesen, Mieke Van Hemelrijck, Jan Bogaerts, Christopher M. Booth, Jan J. Cornelissen, Andre Dekker, Elizabeth A. Eisenhauer, André Freitas, Alessandro Gronchi, Miguel A. Hernán, Frank Hulstaert, Piet Ost, Petr Szturz, Helena M. Verkooijen, Michael W
Defining the role of real-world data in cancer clinical research: The position of the
real-world data, real-world evidence, randomised, pragmatic trials, cancer, clinical research, add-on cohorts
Real-World Data (RWD) are increasingly used in cancer clinical research as an alternative evidence source. RWD studies primarily involve observational data, which offer insights into real-world conditions but may have quality limitations. Some research questions necessitate Randomized Controlled…
Mar 20th • 10 mins read
Laurent Azoulay
Rationale, Strengths, and Limitations of Real-World Evidence in Oncology: A Canadian Review and Perspective
real-world evidence; RWE, real-world studies, RWS, oncology, real-world evidence, RWE, randomized controlled trial, RCT
Data obtained from real-world studies have an integral role in evidence-based medicine, serving as an essential source of safety information and a complement to efficacy data from RCTs. RWE is particularly useful for expanding the evidence base to encompass populations of patients who are not well r…
Apr 26th • 9 mins read
Diana Brixner, PhD, RPh [email protected], Joseph Biskupiak, PhD, MBA, Gary Oderda, PharmD, MPH, Douglas Burgoyne, PharmD, FAMCP, Daniel C Malone, RPh, PhD, FAMCP, Bhakti Arondekar, PhD, MBA, and Alexander Niyazov, PharmD, RPh, MPH
Payer perceptions of the use of real-world evidence in oncology-based decision making
real world evidence, RWE, RCT, randomized controlled trials, payer, perceptions, FDA
US payers find real-world evidence (RWE) useful for improving costs and outcomes in oncology, and for making formulary decisions. Payers prioritize comparative effectiveness evidence but also value other RWE types such as total cost of care, burden of illness, treatment patterns, and economic…
Aug 1st • 12 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
iNIZIO
Transforming oncology: Five frontiers driving progress in cancer care
From biomarker-driven breakthroughs to AI-powered early detection and a renewed commitment to equity and patient centricity, the past 12 months have seen major strides across cancer research, treatment, and communication. At Inizio, we’ve had a front-row seat to this transformation, supporting…
May 16th • 5 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