Results 31 to 40 of about 2,242,374 (316)

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

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

Decrease in rate of multiple sclerosis-related hospitalizations in Portugal [version 1; referees: 2 approved]

F1000Research, 2016
We sought to investigate the rate of multiple sclerosis (MS)-related hospitalizations in Portugal and assess whether there have been temporal changes as described in other countries. Using data from the Portuguese National Discharge Registry, we observed
Marta Pereira, Dimitra Lambrelli, Sreeram V. Ramagopalan   +2 more
doaj   +1 more source

Validation of algorithms to identify colorectal cancer patients from administrative claims data of a Japanese hospital

BMC Health Services Research, 2023
Background Administrative claims data are a valuable source for clinical studies; however, the use of validated algorithms to identify patients is essential to minimize bias.
Takahiro Hirano, Makiko Negishi, Yoshiki Kuwatsuru, Masafumi Arai, Ryozo Wakabayashi, Naoko Saito, Ryohei Kuwatsuru   +6 more
doaj   +1 more source

Integration of real-world evidence from different data sources in health technology assessment

Journal of Pharmacy & Pharmaceutical Sciences, 2023
Real-world evidence (RWE) is being increasingly used by a wide range of stakeholders involved in the therapeutic product lifecycle but remains underutilized in the health technology assessment (HTA) process.
P. Graili, J. Guertin, Kelvin K. W. Chan, Mina Tadrous   +3 more
semanticscholar   +1 more source

Real-world Evidence Needs Careful Interpretation [PDF]

The Journal of Rheumatology, 2021
> Determination plus persistence equals achievement . > > Stanley T. Crawford The Janus kinase (JAK) inhibitors have proven to be popular across the globe for an increasing variety of autoimmune inflammatory disorders seen in rheumatology, dermatology, and gastroenterology1.
openaire   +2 more sources

Real World Evidence in Medical Cannabis Research [PDF]

Therapeutic Innovation & Regulatory Science, 2021
Abstract Background Whilst access to cannabis-based medicinal products (CBMPs) has increased globally subject to relaxation of scheduling laws globally, one of the main barriers to appropriate patient access remains a paucity of high-quality evidence surrounding their clinical effects ...
Rishi Banerjee, Simon Erridge, Oliver Salazar, Nagina Mangal, Daniel Couch, Barbara Pacchetti, Mikael Hans Sodergren   +6 more
openaire   +5 more sources

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

STAN: spatio-temporal attention network for pandemic prediction using real-world evidence

J. Am. Medical Informatics Assoc., 2021
Objective We aim to develop a hybrid model for earlier and more accurate predictions for the number of infected cases in pandemics by (1) using patients’ claims data from different counties and states that capture local disease status and medical ...
Junyi Gao, Rakshith Sharma, Cheng Qian, Lucas Glass, J. Spaeder, J. Romberg, Jimeng Sun, Cao Xiao   +7 more
semanticscholar   +1 more source

Automating Access to Real-World Evidence

JTO Clinical and Research Reports, 2022
Real-world evidence is important in regulatory and funding decisions. Manual data extraction from electronic health records (EHRs) is time-consuming and challenging to maintain. Automated extraction using natural language processing (NLP) and artificial intelligence may facilitate this process.
Marie-Pier Gauthier, MD, Jennifer H. Law, MSc, Lisa W. Le, MSc, Janice J.N. Li, BSc, Sajda Zahir, Sharon Nirmalakumar, BSc, Mike Sung, MD, Christopher Pettengell, BMBCh, Steven Aviv, BBusSc, Ryan Chu, MD, Adrian Sacher, MD, MSc, Geoffrey Liu, MD, MSc, Penelope Bradbury, MBChB, Frances A. Shepherd, MD, Natasha B. Leighl, MD, MMSc, FRCPC, FASCO   +14 more
openaire   +3 more sources