Results 11 to 20 of about 2,242,374 (316)

Real-World Evidence: A Primer

Pharmaceutical Medicine, 2023
Real-world evidence (RWE) is clinical evidence on a medical product's safety and efficacy that is generated using real-world data (RWD) resulting from routine healthcare delivery. There are several sources of RWD, including electronic health records (EHRs), registries, claims/billing data, and patient-generated data, as well as those from mobile health
A. Dang
openaire   +3 more sources

Real World Evidence – Current Developments and Perspectives

International Journal of Environmental Research and Public Health, 2022
Real-world evidence (RWE) is increasingly involved in the early benefit assessment of medicinal drugs. It is expected that RWE will help to speed up approval processes comparable to RWE developments in vaccine research during the COVID-19 pandemic. Definitions of RWE are diverse marking the highly fluid status in this field.
Friedemann Schad, Anja Thronicke
openaire   +3 more sources

A causal roadmap for generating high-quality real-world evidence [PDF]

Journal of Clinical and Translational Science, 2023
Increasing emphasis on the use of real-world evidence (RWE) to support clinical policy and regulatory decision-making has led to a proliferation of guidance, advice, and frameworks from regulatory agencies, academia, professional societies, and industry.
L. E. Dang, Susan Gruber, Hana Lee, I. Dahabreh, E. Stuart, B. Williamson, R. Wyss, Iv'an D'iaz, Debashis Ghosh, Emre Kıcıman, D. Alemayehu, K. Hoffman, C. Vossen, Raymond A. Huml, Henrik Ravn, K. Kvist, R. Pratley, M. Shih, G. Pennello, David Martin, Salina P. Waddy, C. Barr, M. Akacha, J. Buse, M. Laan, M. Petersen   +25 more
semanticscholar   +1 more source

ESMO Guidance for Reporting Oncology real-World evidence (GROW)

ESMO real world data and digital oncology, 2023
Highlights • Real-world evidence in oncology is evolving rapidly with many particularities.• This guidance provides key recommendations for reporting real-world evidence studies in oncology.• Recommendations are based on a review of current evidence and ...
L. Castelo-Branco, A. Pellat, D. Martins-Branco, A. Valachis, J.W.G. Derksen, K. Suijkerbuijk, U. Dafni, T. Dellaporta, A. Vogel, A. Prelaj, R. Groenwold, H. Martins, R. Stahel, J. Bliss, J. Kather, N. Ribelles, F. Perrone, P. S. Hall, R. Dienstmann, C.M. Booth, G. Pentheroudakis, S. Delaloge, M. Koopman   +22 more
semanticscholar   +1 more source

Real-world evidence generation from patients, their caregivers and physicians supporting clinical, regulatory and guideline decisions: an update on Disease Specific Programmes

Current Medical Research and Opinion, 2023
Objective To update on and describe the role of Disease Specific Programmes (DSPs), a multi-perspective real-world data (RWD) source, in the context of the evolution of the value and acceptance of real-world evidence (RWE) in clinical, regulatory and ...
Peter Anderson, Victoria Higgins, Jonathan de Courcy, Katerina Doslikova, Victoria A. Davis, M. Karavali, James Piercy   +6 more
semanticscholar   +1 more source

Real-world Evidence of Axicabtagene Ciloleucel for the Treatment of Large B-Cell Lymphoma in the United States.

Transplantation and Cellular Therapy, 2022
BACKGROUND Axicabtagene ciloleucel (axi-cel) is a standard-of-care for relapsed or refractory (r/r) large B-cell lymphoma (LBCL) with two or more lines of prior therapy.
C. Jacobson, F. Locke, Long Ma, Julius Asubonteng, Zhen-Huan Hu, T. Siddiqi, Saira S. Ahmed, A. Ghobadi, D. Miklos, Yi-Chung Lin, M. Perales, M. Lunning, Megan M. Herr, B. Hill, S. Ganguly, Hua Dong, S. Nikiforow, M. Hooper, J. Kawashima, Hairong Xu, M. Pasquini   +20 more
semanticscholar   +1 more source

Risk and Outcome of Breakthrough COVID-19 Infections in Vaccinated Patients With Cancer: Real-World Evidence From the National COVID Cohort Collaborative

Journal of Clinical Oncology, 2022
PURPOSE To provide real-world evidence on risks and outcomes of breakthrough COVID-19 infections in vaccinated patients with cancer using the largest national cohort of COVID-19 cases and controls. METHODS We used the National COVID Cohort Collaborative (
Qianqian Song, Benjamin Bates, Y. R. Shao, Fang-Chi Hsu, Feifan Liu, V. Madhira, A. Mitra, Timothy Bergquist, R. Kavuluru, Xiaochun Li, Noha Sharafeldin, Jing Su, U. Topaloglu   +12 more
semanticscholar   +1 more source

Advancing digital health applications: priorities for innovation in real-world evidence generation.

The Lancet Digital Health, 2022
In 2019, Germany passed the Digital Healthcare Act, which, among other things, created a "Fast-Track" regulatory and reimbursement pathway for digital health applications in the German market.
A. Stern, J. Brönneke, J. Debatin, Julia Hagen, H. Matthies, Smit Patel, I. Clay, Bjoern M. Eskofier, A. Herr, Kurt Hoeller, A. Jaksa, D. B. Kramer, Mattias Kyhlstedt, K. Lofgren, N. Mahendraratnam, H. Muehlan, S. Reif, Lars Riedemann, J. Goldsack   +18 more
semanticscholar   +1 more source

Real-World Evidence of CAR T-cell Therapy in Older Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma.

Blood, 2023
The emergence of chimeric antigen receptor (CAR) T-cell therapy has changed the treatment landscape for diffuse large B-cell lymphoma (DLBCL), however, real-world evidence reporting outcomes among older patients treated with CAR T-cell therapy is limited.
D. Chihara, L. Liao, J. Tkacz, Anjali Franco, B. Lewing, K. Kilgore, L. Nastoupil, Lei Chen   +7 more
semanticscholar   +1 more source

Harnessing Real-World Evidence to Advance Cancer Research

Current Oncology, 2023
Randomized controlled trials (RCTs) form a cornerstone of oncology research by generating evidence about the efficacy of therapies in selected patient populations.
Monica Tang, Sallie-Anne Pearson, R. Simes, Boon H. Chua   +3 more
semanticscholar   +1 more source