Results for 'Real-world data'
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
Min Jeong Kim, Hyo Jung Kim, Danbee Kang, Hee Kyung Ahn, Soo-Yong Shin, Juhee Cho, Yeon Hee Park,
Preliminary Attainability Assessment of Real-World Data for Answering Major Clinical Research Questions in Breast Cancer Brain Metastasis: Framework Development and Validation Study
real-world data, preliminary attainability assessment, observational study, clinical data warehouse, PAR framework, brain metastasis, breast cancer
The study proposes the PAR framework for data attainability screening in clinical research, particularly useful for addressing unmet clinical needs in BCBM. A survey showed clinical questions had a mean score of 4.37, indicating the significance of these questions. RWE generation is crucial…
Oct 9th • 4 mins read
Gracy Crane, John C. W. Lim, Churn-Shiouh Gau, Jipan Xie & Laura Chu
The challenges and opportunities in using real-world data to drive advances in healthcare in East Asia: expert panel recommendations
Real-world data, real-world evidenc, East Asia, policy recommendations, decision-making support, East Asia, expert, RWD, RWE
Recommend approaches to improve the use of Real-World Evidence (RWE) in healthcare decision-making in East Asia and beyond. Encourage large-scale collaborations involving diverse stakeholders. Key stakeholders include government agencies, hospitals, research organizations, patient groups, and th…
Jun 28th • 13 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
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
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
Bruce A. Feinberg, DO Ajeet Gajra, MBBS, MD Marjorie E. Zettler, PhD, MPH Todd D. Phillips, PharmD Eli G. Phillips Jr., PharmD, JD Jonathan K. Kish, PhD, MPH
Use of Real-World Evidence to Support FDA Approval of Oncology Drugs
Food and Drug Administration, oncology drug approval, real-world data, real-world evidence
Real-world evidence (RWE) has gained increased attention in recent years as a complement to traditional clinical trials. The use of RWE to establish the efficacy of oncology drugs for Food and Drug Administration (FDA) approval has not been described. In this paper, we review 5 recent examples whe…
Sep 14th • 16 mins read
Jonathon Webster, MD and B. Douglas Smith, MD
The Case for Real-world Evidence in the Future of Clinical Research on Chronic Myeloid Leukemia
Real world data, FDA, RCT, RWE, RWD
In light of recently published guidelines from the US Food and Drug Administration (FDA) on the communication of real-world data (RWD) and real-world evidence (RWE) to support regulatory decision making, it is important to understand the following key points and concepts: Development of RWD and R…
Jan 29th • 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
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
H. K. van Halteren, J. Bennouna, B.Brasiuniene, A.J. Cunquero Tomas, A.M. Garcia Trinidad, A. Indini, G. Liposits, B. Pellegrino, L. Popovic, A.Tan, R.Vidra & M.Strijbos
Twelve ESMO Congress 2022 breakthroughs: practicing oncologists' perceptions and potential application on presented data
ESMO Congress 2022, review, methodology, implementation
Background: At the ESMO Congress 2022, numerous clinical trial outcomes were presented, highlighting the importance of structuring data to weigh treatment burden against benefits. Materials and Methods: A narrative non-systematic review of 12 selected oral presentations was conducted, focusing…
Jan 10th • 12 mins read
Bhakti Arondekar, Mei Sheng Duh, Rachel H. Bhak, Maral DerSarkissian, Lynn Huynh, Kelsey Wang, John Wojciehowski, Melody Wu, Bryon Wornson, Alexander Niyazov, George D. Demetri
Real-World Evidence in Support of Oncology Product Registration: A Systematic Review of New Drug Application and Biologics License Application
RWE, Biologics License, FDA, BLA, suplements
The FDA emphasizes early engagement and transparent protocols in Real-World Evidence (RWE) studies. Aligning RWE populations with pivotal trial populations is crucial, often achieved through criteria matching and propensity score methodologies. Major critiques include differences in tumor asse…
Jan 1st • 12 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
Forbes Books Press Release Official
New Book Unites Oncology’s Brightest Minds To Innovate Cancer Cures
Voices of Oncology, Cancer cures, Oncology Voice Network, Kirk V. Shepard, Ramin Farhood, Forbes Books, Cancer treatment innovation, Oncology collaboration, Patient engagement in oncology, Precision medicine cancer
Voices of Oncology: Fostering a Collaborative Community of Experts to Accelerate Cancer Cures is a book by Kirk V. Shepard, M.D., and Ramin Farhood, PharmD, M.B.A., featuring insights from 33 contributors in the oncology field. It is available on platforms like Amazon and Barne…
Sep 9th • 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
iNIZIO
Expert perspectives live from ASCO® 2025
At the 2025 ASCO® Annual Meeting, three of our experts sat down with OncoDaily to share their unique perspectives in oncology – from amplifying the patient voice to unlocking real-world impact through data and AI. Watch the videos below. Matthew Hoelzle | Medical strategy, AI and real-wor…
Jul 2nd • 1 min 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