Results 41 to 50 of about 2,671,764 (310)

Clinical Pharmacology Applications of Real‐World Data and Real‐World Evidence in Drug Development and Approval–An Industry Perspective

Clinical pharmacology and therapy, 2023
Since the 21st Century Cures Act was signed into law in 2016, real‐world data (RWD) and real‐world evidence (RWE) have attracted great interest from the healthcare ecosystem globally. The potential and capability of RWD/RWE to inform regulatory decisions
Rui Zhu, B. Vora, S. Menon, I. Younis, Gaurav Dwivedi, Zhaoling Meng, A. Datta-Mannan, Pooja Manchandani, Satyaprakash Nayak, B. Tammara, P. Garhyan, S. Iqbal, Simon Dagenais, Pascal Chanu, A. Mukherjee, C. Ghobadi   +15 more
semanticscholar   +1 more source

Use of Real‐World Evidence to Drive Drug Development Strategy and Inform Clinical Trial Design

Clinical pharmacology and therapy, 2021
Interest in real‐world data (RWD) and real‐world evidence (RWE) to expedite and enrich the development of new biopharmaceutical products has proliferated in recent years, spurred by the 21st Century Cures Act in the United States and similar policy ...
S. Dagenais, L. Russo, Ann M. Madsen, Jennifer Webster, L. Becnel   +4 more
semanticscholar   +1 more source

Application of Comprehensive Artificial intelligence Retinal Expert (CARE) system: a national real-world evidence study.

The Lancet Digital Health, 2021
BACKGROUND Medical artificial intelligence (AI) has entered the clinical implementation phase, although real-world performance of deep-learning systems (DLSs) for screening fundus disease remains unsatisfactory.
Duoru Lin, J. Xiong, Congxin Liu, Lanqin Zhao, Zhongwen Li, Shanshan Yu, Xiaohang Wu, Zongyuan Ge, Xinyue Hu, Bin Wang, M. Fu, Xin Zhao, Xin Wang, Yi Zhu, Chuan Chen, Tao Li, Yong-hao Li, W. Wei, Mingwei Zhao, Jianqiao Li, Fan Xu, Lin Ding, Gang Tan, Yi Xiang, Yongcheng Hu, Ping Zhang, Yu Han, J. Li, Lai Wei, Pengzhi Zhu, Yizhi Liu, Weirong Chen, D. Ting, T. Y. Wong, Yuzhong Chen, Haotian Lin   +35 more
semanticscholar   +1 more source

Reproducibility of real-world evidence studies using clinical practice data to inform regulatory and coverage decisions

Nature Communications, 2022
Studies that generate real-world evidence on the effects of medical products through analysis of digital data collected in clinical practice provide key insights for regulators, payers, and other healthcare decision-makers.
Shirley V. Wang, S. K. Sreedhara, S. Schneeweiss, Jessica M. Joshua J. Krista F. Elisabetta Yinzhu Moa Mufad Franklin Gagne Huybrechts Patorno Jin Lee Mahesri , J. Franklin, J. Gagne, K. Huybrechts, Elisabetta Patorno, Yinzhu Jin, Moa P. Lee, M. Mahesri, Ajinkya M Pawar, Julie Barberio, Lily G. Bessette, Kristyn Chin, N. Gautam, A. S. Ortiz, Ellen Sears, K. Stefanini, Mimi Zakarian, Sara Z Dejene, James R. Rogers, Gregory Brill, J. Landon, J. Lii, T. Tsacogianis, Seanna M. Vine, E. Garry, Liz Gibbs, Monica Gierada, Danielle L. Isaman, E. Payne, S. Alwardt, P. Arlett, D. Bartels, A. Bate, J. Berlin, A. Bourke, B. Bradbury, Jeffrey S. Brown, K. Burnett, T. Brennan, K. Chan, N. Choi, F. de Vries, H. Eichler, K. Filion, Lisa Freeman, J. Hallas, L. Happe, Sean Hennessy, P. Jónsson, J. Ioannidis, J. Jiménez, K. Kahler, C. Laine, E. Loder, A. Makady, David Martin, Michael D. Nguyen, B. Nosek, Richard Platt, Robert W. Platt, J. Seeger, W. Shrank, L. Smeeth, Henrik Toft Sørensen, P. Tugwell, Y. Uyama, R. Willke, W. Winkelmayer, D. Zarin   +71 more
semanticscholar   +1 more source

Health-related quality of life burden of nonalcoholic steatohepatitis: a robust pragmatic literature review

Journal of Patient-Reported Outcomes, 2018
Objective Nonalcoholic steatohepatitis (NASH) is a form of chronic liver disease (CLD): patients have an increased risk of developing cirrhosis, liver failure, and complications (e.g. hepatocellular carcinoma). NASH has a high clinical burden, and likely
Tessa Kennedy-Martin, Jay P. Bae, Rosirene Paczkowski, Emily Freeman   +3 more
doaj   +1 more source

Impact of "time zero" of Follow-Up Settings in a Comparative Effectiveness Study Using Real-World Data with a Non-user Comparator: Comparison of Six Different Settings

Drugs - Real World Outcomes, 2022
Background Time-related bias can lead to misleading conclusions. Properly setting the "time zero" of follow-up is crucial for avoiding these biases. However, the time-zero setting is challenging when comparing users and non-users of a study drug because ...
Ryozo Wakabayashi, Takahiro Hirano, Thomas Laurent, Yoshiki Kuwatsuru, Ryohei Kuwatsuru   +4 more
doaj   +1 more source

Guidelines of the International Headache Society for Real-World Evidence studies in migraine and cluster headache

Cephalalgia
Real-world evidence studies are an important tool for investigating the effectiveness, safety and tolerability of treatments for headache disorders in clinical practice.
P. Pozo‐Rosich, N. van Veelen, E. Caronna, G. Vaghi, M. Torres-Ferrús, Britt W. H. van der Arend, Peter J. Goadsby, M. Ashina, Shuu-Jiun Wang, H. Diener, Cristina Tassorelli, G. Terwindt   +11 more
semanticscholar   +1 more source

Real-World Evidence for Regulatory Decision-Making: Guidance From Around the World.

Clinical Therapeutics, 2022
PURPOSE Interest in leveraging real-world evidence (RWE) to support regulatory decision making for product effectiveness has been increasing globally as evident by the increasing number of regulatory frameworks and guidance documents. However, acceptance
Leah Burns, Nadege Le Roux, Robert Kalesnik-Orszulak, J. Christian, Mathias Hukkelhoven, F. Rockhold, J. O’Donnell   +6 more
semanticscholar   +1 more source

Treatment pathways, economic burden and clinical outcomes in new users of inhaled corticosteroid/long-acting B2-agonist dual therapy with chronic obstructive pulmonary disease in a primary care setting in England: a retrospective cohort study

BMJ Open
Objective Management of chronic obstructive pulmonary disease (COPD) with inhaled corticosteroid/long-acting β2-agonist (ICS/LABA) improves lung function and health status and reduces COPD exacerbation risk versus monotherapy.
Victoria Banks, Robert Wood, Gema Requena, Alexandrosz Czira, Theo Tritton, Rosie Wild, Chris Compton, Afisi Ismaila   +7 more
doaj   +1 more source

Evaluating the Performance of High-Dimensional Propensity Scores Compared with Standard Propensity Scores for Comparing Antihypertensive Therapies in the CPRD GOLD Database

Cardiology and Therapy, 2023
Introduction Propensity score (PS) matching is widely used in medical record studies to create balanced treatment groups, but relies on prior knowledge of confounding factors.
Virginie Simon, Jade Vadel
doaj   +1 more source