Results for 'RWD'
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
Kelvin Chan, Seungree Nam, Bill Evans, Claire de Oliveira Alexandra Chambers, Scott Gavura, Jeffrey Hoch, Rebecca E Mercer, Wei Fang Dai, Jaclyn Beca, Mina Tadrous, Wanrudee Isaranuwatchai
Developing a framework to incorporate real-world evidence in cancer drug funding decisions: the Canadian Real-world Evidence for Value of Cancer Drugs (CanREValue) collaboration
RWD, Canadian Real World Evidence, cancer drug, funding, framework
Oncology therapy is becoming more expensive, challenging the affordability and sustainability of drug programs globally. Health technology assessment organizations use clinical trials for drug funding decisions, which may not reflect real-world outcomes. The Canadian Real-world Evidence for Valu…
Jan 7th • 8 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
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
Ashley Woolmore , Dirk Arnold , Jean‐Yves Blay , Christian Buske , Alfredo Carrato , Winald Gerritsen , Marc Peeters , Jesus Garcia‐Foncillas , David Kerr
The Oncology Data Network (ODN): Methodology, Challenges, and Achievements
The oncology data network, ODN
The Oncology Data Network (ODN) aims to create a collaborative infrastructure for precision medicine, established in over seven European countries with 124 cancer centers. The ODN collects concise data on cancer medicine use, adhering to EU GDPR regulations, and has a central European Data Wareho…
May 21st • 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
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
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