Results for 'Randomized trials'
Shubham Sharma, J Connor Wells, Wilma M Hopman, Joseph C Del Paggio, Bishal Gyawali, Nazik Hammad, Annette E Hay, Christopher M Booth
Cancer, Clinical Trials, and Canada: Our Contribution to Worldwide Randomized Controlled Trials
cancer, clinical trials, research funding, Canada, high-income countries
This document reviews Canadian involvement in oncology randomized controlled trials (RCTs) from 2014-2017, comparing them to those from other high-income countries (HICs). Canada contributed to 155 (24%) of 636 HIC-led RCTs. Canadian RCTs focused more on palliative care (72%) compared to 62% in …
Apr 13th • 10 mins read
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
Xuanyi Li, Elizabeth A. Sigworth, Adrianne H. Wu, Jess Behrens, Shervin A. Etemad, Seema Nagpal, Ronald S. Go, Kristin Wuichet, Eddy J. Chen, Samuel M. Rubinstein, Neeta K. Venepalli, Benjamin F. Tillman, Andrew J. Cowan, Martin W. Schoen, Andrew Malty, J
Seven decades of chemotherapy clinical trials: a pan-cancer social network analysis
Cancer Medical research, Randomized controlled trials, Clinical trial design
Clinical trials are crucial in establishing cancer care standards, but the social dynamics among researchers in this field have not been extensively studied. A social network analysis of authors involved in chemotherapy-based prospective trials from 1946 to 2018 reveals significant insights. The …
Oct 16th • 12 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
Massimo Di Maio, Francesco Perrone, Pierfranco Conte
Real-World Evidence in Oncology: Opportunities and Limitations
Real‐world evidence, Clinical trials, Cancer treatments
Randomized controlled trials (RCTs) are traditionally viewed as the gold standard for evaluating treatment efficacy, but real-world evidence (RWE) is gaining traction in oncology for addressing questions not fully answered by RCTs. RWE is derived from health records, cancer registries, and other …
Dec 24th • 8 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
Anushka Walia, Alyson Haslam, Vinay Prasad
FDA validation of surrogate endpoints in oncology: 2005–2022
FDA drug approval, surrogate endpoints, oncology drugs, overall survival correlation, clinical trials analysis, drug approval guidelines
ere are summary bullets based on the provided text: The FDA has increasingly approved oncologic drugs based on surrogate endpoints, which often lack a demonstrated correlation with clinically meaningful outcomes like overall survival. A review of FDA analyses from 2005 to 2022 examined the valid…
Dec 1st • 20 mins read
Consolacion Molto, Ariadna Tibau, Aida Bujosa, Jose Carlos Tapia, Abhenil Mittal, Faris Tamimi & Eitan Amir
Association between control group therapy and magnitude of clinical benefit of cancer drugs
control group therapy, clinical benefit scales, ESMO-MCBS, ASCO-VF, randomized trials
The study investigated the impact of control group therapy on various clinical benefit scales like ASCO-VF, ESMO-MCBS, NCCN Evidence Blocks, and ASCO-CRC. Researchers analyzed cancer drugs approved between 2012 and 2021 using data from randomized controlled trials (RCTs) listed on Drugs@FDA. Sig…
Dec 9th • 20 mins read
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
Garth W. Strohbehn, MD, MPhil, Allen S. Lichter, MD and Mark J. Ratain, MD
US Government Payer-Funded Trials to Address Oncology's Drug-Dosing Conundrum: A Congressional Call to Action?
ORF, NCTN, dosing, clinical trials, FDA
Since the mid-20th century, cancer drug development has been driven by the "more is better" assumption, seeking the maximum tolerated dose in early trials. The FDA's Oncology Center of Excellence (OCE) Project Optimus (2021) requires dose optimization for new oncology drugs, but this does not…
Feb 13th • 5 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
Fernando Petracci, Chirag Ghai, Andrew Pangilinan, Luis Alberto Suarez, Roberto Uehara, Marwan Ghosn
Use of real-world evidence for oncology clinical decision making in emerging economies
Asia-Pacific, effectiveness, electronic database, health policy, Latin America, Middle East, randomized clinical trials, real-world data, real-world evidence, safety
Despite RWE being a relatively nascent concept in emerging economies, we have seen evidence of increasing use over the past 5 years growing at 11% per year. That said, barriers specific to emerging economies need to be overcome through collaborative efforts, with regulatory agencies at the forefront…
May 5th • 12 mins read
Ronak Saluja, BS, Louis Everest, Sierra Cheng, Matthew Cheung, MD; Kelvin K. W. Chan, MD, MSc, PhD
Assessment of Whether the American Society of Clinical Oncology's Value Framework and the European Society for Medical Oncology's Magnitude of Clinical Benefit
ASCO, ESMO, value frameworks, randomized controlled trials, ASCO-CBS, ESMO-PMCBG
The ASCO-VF and ESMO-MCBS frameworks currently lack the ability to measure absolute survival benefit, which limits their effectiveness in comparing clinical benefits across different drugs and in establishing value. The authors of the ASCO framework have acknowledged the need for both relative and a…
May 16th • 15 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
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
Pan Pantziarka, Ciska Verbaanderd & Lydie Meheus
Biased by design? Clinical trials and patient benefit in oncology
clinical trial design, drug development, drug registration, patient benefit, risks of bias
The study by Naci et al. raises numerous questions relating to the design characteristics, risks of bias and reporting of pivotal clinical trials in oncology. These findings add to the existing body of evidence that suggests drug development in oncology is not delivering the clinical benef…
Nov 27th • 3 mins read
Yuan Zhang, Xu Liu, Ying-Qin Li, Ling-Long Tang, Lei Chen, Jun Ma
A Field Test of Major Value Frameworks in Chemotherapy of Nasopharyngeal Carcinoma-To Know, Then to Measure
value framework, European Society for Medical Oncology, Magnitude of Clinical Benefit Scale, American Society of Clinical Oncology, drug therapy, nasopharyngeal neoplasms
The European Society for Medical Oncology (ESMO) and the American Society of Clinical Oncology (ASCO) have developed frameworks to evaluate cancer treatments, particularly for nasopharyngeal carcinoma. A study compared these frameworks using data from 15 randomized controlled trials of systemic c…
Aug 12th • 10 mins read
Melissa H. Roberts & Gary T. Ferguson
Real-World Evidence: Bridging Gaps in Evidence to Guide Payer Decisions
Real world evidence, RWE, payer decisions, RWD
Randomized controlled trials (RCTs) are preferred by payers for health technology assessments and coverage decisions, but they may not reflect real-world clinical practice. Real-world evidence (RWE) from observational studies can fill evidence gaps not addressed by RCTs and is valuable for payer …
Jun 18th • 6 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