Matches in SemOpenAlex for { <https://semopenalex.org/work/W3172542805> ?p ?o ?g. }
- W3172542805 abstract "Real world evidence (RWE) and real-world data (RWD) are drawing ever-increasing attention in the pharmaceutical industry and drug regulatory authorities (DRAs) all over the world due to their paramount role in supporting drug development and regulatory decision making. However, there is little systematic documentary analysis about how RWE was integrated for the use by the DRAs in evaluating new treatment approaches and monitoring post-market safety. This study aimed to analyze and discuss the integration of RWE into regulatory decision-making process from the perspective of DRAs. Different development strategies to develop and adopt RWE by the DRAs in the US, Europe, and China were reviewed and compared, and the challenges encountered were discussed. It was found that different strategies on development of RWE were applied by FDA, EMA, and NMPA. The extent to which RWE was adopted in China was relatively limited compared to that in the US and EU, which was highly related to the national pharmaceutical environment and development stages. A better understanding of the overall goals, inputs, activities, outputs, and outcomes in developing RWE will help inform actions to harness RWD and leverage RWE for better health care decisions." @default.
- W3172542805 created "2021-06-22" @default.
- W3172542805 creator A5013665230 @default.
- W3172542805 creator A5021969579 @default.
- W3172542805 creator A5023474335 @default.
- W3172542805 creator A5025302533 @default.
- W3172542805 creator A5029762841 @default.
- W3172542805 creator A5036060043 @default.
- W3172542805 creator A5072671445 @default.
- W3172542805 creator A5087324890 @default.
- W3172542805 creator A5087592842 @default.
- W3172542805 creator A5088701182 @default.
- W3172542805 date "2021-05-31" @default.
- W3172542805 modified "2023-10-14" @default.
- W3172542805 title "Integrating Real-World Evidence in the Regulatory Decision-Making Process: A Systematic Analysis of Experiences in the US, EU, and China Using a Logic Model" @default.
- W3172542805 cites W1484976590 @default.
- W3172542805 cites W1572634385 @default.
- W3172542805 cites W1578197041 @default.
- W3172542805 cites W1936058759 @default.
- W3172542805 cites W1965717563 @default.
- W3172542805 cites W2006751016 @default.
- W3172542805 cites W2109550098 @default.
- W3172542805 cites W2138055093 @default.
- W3172542805 cites W2161563879 @default.
- W3172542805 cites W2164508393 @default.
- W3172542805 cites W2405799747 @default.
- W3172542805 cites W2409717771 @default.
- W3172542805 cites W2488041581 @default.
- W3172542805 cites W2591298066 @default.
- W3172542805 cites W2600228895 @default.
- W3172542805 cites W2611824907 @default.
- W3172542805 cites W2613016301 @default.
- W3172542805 cites W2735337841 @default.
- W3172542805 cites W2742030274 @default.
- W3172542805 cites W2755504031 @default.
- W3172542805 cites W2768796258 @default.
- W3172542805 cites W2769682735 @default.
- W3172542805 cites W2783405072 @default.
- W3172542805 cites W2784620362 @default.
- W3172542805 cites W2792424406 @default.
- W3172542805 cites W2800123898 @default.
- W3172542805 cites W2807879548 @default.
- W3172542805 cites W2899593300 @default.
- W3172542805 cites W2919285695 @default.
- W3172542805 cites W2926571839 @default.
- W3172542805 cites W2938387710 @default.
- W3172542805 cites W2940033607 @default.
- W3172542805 cites W2940217897 @default.
- W3172542805 cites W2945294914 @default.
- W3172542805 cites W2947412834 @default.
- W3172542805 cites W2949888634 @default.
- W3172542805 cites W2954402774 @default.
- W3172542805 cites W2960245070 @default.
- W3172542805 cites W2965362447 @default.
- W3172542805 cites W2969599115 @default.
- W3172542805 cites W2984155431 @default.
- W3172542805 cites W2989467035 @default.
- W3172542805 cites W2995118312 @default.
- W3172542805 cites W2995437111 @default.
- W3172542805 cites W3003751458 @default.
- W3172542805 cites W3005648855 @default.
- W3172542805 cites W3009599329 @default.
- W3172542805 cites W3121395586 @default.
- W3172542805 cites W3132725942 @default.
- W3172542805 cites W3152625822 @default.
- W3172542805 doi "https://doi.org/10.3389/fmed.2021.669509" @default.
- W3172542805 hasPubMedCentralId "https://www.ncbi.nlm.nih.gov/pmc/articles/8200400" @default.
- W3172542805 hasPubMedId "https://pubmed.ncbi.nlm.nih.gov/34136505" @default.
- W3172542805 hasPublicationYear "2021" @default.
- W3172542805 type Work @default.
- W3172542805 sameAs 3172542805 @default.
- W3172542805 citedByCount "18" @default.
- W3172542805 countsByYear W31725428052021 @default.
- W3172542805 countsByYear W31725428052022 @default.
- W3172542805 countsByYear W31725428052023 @default.
- W3172542805 crossrefType "journal-article" @default.
- W3172542805 hasAuthorship W3172542805A5013665230 @default.
- W3172542805 hasAuthorship W3172542805A5021969579 @default.
- W3172542805 hasAuthorship W3172542805A5023474335 @default.
- W3172542805 hasAuthorship W3172542805A5025302533 @default.
- W3172542805 hasAuthorship W3172542805A5029762841 @default.
- W3172542805 hasAuthorship W3172542805A5036060043 @default.
- W3172542805 hasAuthorship W3172542805A5072671445 @default.
- W3172542805 hasAuthorship W3172542805A5087324890 @default.
- W3172542805 hasAuthorship W3172542805A5087592842 @default.
- W3172542805 hasAuthorship W3172542805A5088701182 @default.
- W3172542805 hasBestOaLocation W31725428051 @default.
- W3172542805 hasConcept C111919701 @default.
- W3172542805 hasConcept C112930515 @default.
- W3172542805 hasConcept C119857082 @default.
- W3172542805 hasConcept C127413603 @default.
- W3172542805 hasConcept C144133560 @default.
- W3172542805 hasConcept C153083717 @default.
- W3172542805 hasConcept C17744445 @default.
- W3172542805 hasConcept C189708586 @default.
- W3172542805 hasConcept C191935318 @default.
- W3172542805 hasConcept C195094911 @default.
- W3172542805 hasConcept C199539241 @default.
- W3172542805 hasConcept C2779473830 @default.
- W3172542805 hasConcept C2780035454 @default.