FRINK Linked Data Fragments server

Matches in SemOpenAlex for { <https://semopenalex.org/work/W4384264039> ?p ?o ?g. }

• W4384264039 endingPage "801" @default.
• W4384264039 startingPage "795" @default.
• W4384264039 abstract "Regulators are faced with many challenges surrounding health data usage, including privacy, fragmentation, validity, and generalizability, especially in the European Union, for which synthetic data may provide innovative solutions. Synthetic data, defined as data artificially generated rather than captured in the real world, are increasingly being used for healthcare research purposes as a proxy to real‐world data (RWD). Currently, there are barriers particularly challenging in Europe, where sharing patient's data is strictly regulated, costly, and time‐consuming, causing delays in evidence generation and regulatory approvals. Recent initiatives are encouraging the use of synthetic data in regulatory decision making and health technology assessment to overcome these challenges, but synthetic data have still to overcome realistic obstacles before their adoption by researchers and regulators in Europe. Thus, the emerging use of RWD and synthetic data by pharmaceutical and medical device industries calls regulatory bodies to provide a framework for proper evidence generation and informed regulatory decision making. As the provision of data becomes more ubiquitous in scientific research, so will innovations in artificial intelligence, machine learning, and generation of synthetic data, making the exploration and intricacies of this topic all the more important and timely. In this review, we discuss the potential merits and challenges of synthetic data in the context of decision making in the European regulatory environment. We explore the current uses of synthetic data and ongoing initiatives, the value of synthetic data for regulatory purposes, and realistic barriers to the adoption of synthetic data in healthcare." @default.
• W4384264039 created "2023-07-14" @default.
• W4384264039 creator A5002069785 @default.
• W4384264039 creator A5003667682 @default.
• W4384264039 creator A5020932811 @default.
• W4384264039 creator A5035037550 @default.
• W4384264039 creator A5039581100 @default.
• W4384264039 creator A5051682707 @default.
• W4384264039 creator A5063374109 @default.
• W4384264039 creator A5063633139 @default.
• W4384264039 creator A5065824018 @default.
• W4384264039 creator A5074995793 @default.
• W4384264039 creator A5087226030 @default.
• W4384264039 creator A5092467350 @default.
• W4384264039 creator A5092467351 @default.
• W4384264039 date "2023-08-24" @default.
• W4384264039 modified "2023-09-23" @default.
• W4384264039 title "A Case for Synthetic Data in Regulatory Decision‐Making in Europe" @default.
• W4384264039 cites W149976140 @default.
• W4384264039 cites W2102803508 @default.
• W4384264039 cites W2765725161 @default.
• W4384264039 cites W2884880012 @default.
• W4384264039 cites W2921914364 @default.
• W4384264039 cites W2928613965 @default.
• W4384264039 cites W2940033607 @default.
• W4384264039 cites W2953312545 @default.
• W4384264039 cites W3012641931 @default.
• W4384264039 cites W3041938240 @default.
• W4384264039 cites W3066358522 @default.
• W4384264039 cites W3082373586 @default.
• W4384264039 cites W3088465102 @default.
• W4384264039 cites W3091504090 @default.
• W4384264039 cites W3091951858 @default.
• W4384264039 cites W3104912879 @default.
• W4384264039 cites W3109650690 @default.
• W4384264039 cites W3110404953 @default.
• W4384264039 cites W3111996834 @default.
• W4384264039 cites W3112508023 @default.
• W4384264039 cites W3113905359 @default.
• W4384264039 cites W3120071807 @default.
• W4384264039 cites W3135275361 @default.
• W4384264039 cites W3135544356 @default.
• W4384264039 cites W3155972762 @default.
• W4384264039 cites W3162740584 @default.
• W4384264039 cites W3166254754 @default.
• W4384264039 cites W3197418972 @default.
• W4384264039 cites W3200237416 @default.
• W4384264039 cites W3209507465 @default.
• W4384264039 cites W4200027480 @default.
• W4384264039 cites W4200171560 @default.
• W4384264039 cites W4200366874 @default.
• W4384264039 cites W4220930667 @default.
• W4384264039 cites W4220960296 @default.
• W4384264039 cites W4223519550 @default.
• W4384264039 cites W4224311959 @default.
• W4384264039 cites W4281630533 @default.
• W4384264039 cites W4283008962 @default.
• W4384264039 cites W4283761334 @default.
• W4384264039 cites W4285981784 @default.
• W4384264039 cites W4290729089 @default.
• W4384264039 doi "https://doi.org/10.1002/cpt.3001" @default.
• W4384264039 hasPubMedId "https://pubmed.ncbi.nlm.nih.gov/37441734" @default.
• W4384264039 hasPublicationYear "2023" @default.
• W4384264039 type Work @default.
• W4384264039 citedByCount "0" @default.
• W4384264039 crossrefType "journal-article" @default.
• W4384264039 hasAuthorship W4384264039A5002069785 @default.
• W4384264039 hasAuthorship W4384264039A5003667682 @default.
• W4384264039 hasAuthorship W4384264039A5020932811 @default.
• W4384264039 hasAuthorship W4384264039A5035037550 @default.
• W4384264039 hasAuthorship W4384264039A5039581100 @default.
• W4384264039 hasAuthorship W4384264039A5051682707 @default.
• W4384264039 hasAuthorship W4384264039A5063374109 @default.
• W4384264039 hasAuthorship W4384264039A5063633139 @default.
• W4384264039 hasAuthorship W4384264039A5065824018 @default.
• W4384264039 hasAuthorship W4384264039A5074995793 @default.
• W4384264039 hasAuthorship W4384264039A5087226030 @default.
• W4384264039 hasAuthorship W4384264039A5092467350 @default.
• W4384264039 hasAuthorship W4384264039A5092467351 @default.
• W4384264039 hasConcept C105639569 @default.
• W4384264039 hasConcept C105795698 @default.
• W4384264039 hasConcept C112930515 @default.
• W4384264039 hasConcept C142724271 @default.
• W4384264039 hasConcept C144133560 @default.
• W4384264039 hasConcept C151730666 @default.
• W4384264039 hasConcept C154945302 @default.
• W4384264039 hasConcept C160735492 @default.
• W4384264039 hasConcept C160920958 @default.
• W4384264039 hasConcept C17744445 @default.
• W4384264039 hasConcept C199539241 @default.
• W4384264039 hasConcept C204787440 @default.
• W4384264039 hasConcept C2522767166 @default.
• W4384264039 hasConcept C27158222 @default.
• W4384264039 hasConcept C2779343474 @default.
• W4384264039 hasConcept C2779965156 @default.
• W4384264039 hasConcept C2910001868 @default.
• W4384264039 hasConcept C3090818 @default.
• W4384264039 hasConcept C33923547 @default.

• next