FRINK Linked Data Fragments server

Matches in SemOpenAlex for { <https://semopenalex.org/work/W3215111505> ?p ?o ?g. }

• W3215111505 endingPage "89" @default.
• W3215111505 startingPage "77" @default.
• W3215111505 abstract "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 efforts in other countries, willingness by regulators to consider RWE in their decisions, demands from third-party payers, and growing concerns about the limitations of traditional clinical trials. Although much of the recent literature on RWE has focused on potential regulatory uses (e.g., product approvals in oncology or rare diseases based on single-arm trials with external control arms), this article reviews how biopharmaceutical companies can leverage RWE to inform internal decisions made throughout the product development process. Specifically, this article will review use of RWD to guide pipeline and portfolio strategy; use of novel sources of RWD to inform product development, use of RWD to inform clinical development, use of advanced analytics to harness big RWD, and considerations when using RWD to inform internal decisions. Topics discussed will include the use of molecular, clinicogenomic, medical imaging, radiomic, and patient-derived xenograft data to augment traditional sources of RWE, the use of RWD to inform clinical trial eligibility criteria, enrich trial population based on predicted response, select endpoints, estimate sample size, understand disease progression, and enhance diversity of participants, the growing use of data tokenization and advanced analytical techniques based on artificial intelligence in RWE, as well as the importance of data quality and methodological transparency in RWE." @default.
• W3215111505 created "2021-12-06" @default.
• W3215111505 creator A5027043074 @default.
• W3215111505 creator A5028540543 @default.
• W3215111505 creator A5032298796 @default.
• W3215111505 creator A5037226361 @default.
• W3215111505 creator A5058966531 @default.
• W3215111505 date "2021-11-28" @default.
• W3215111505 modified "2023-10-17" @default.
• W3215111505 title "Use of Real‐World Evidence to Drive Drug Development Strategy and Inform Clinical Trial Design" @default.
• W3215111505 cites W1786290806 @default.
• W3215111505 cites W2025156179 @default.
• W3215111505 cites W2032120877 @default.
• W3215111505 cites W2068699438 @default.
• W3215111505 cites W2096202600 @default.
• W3215111505 cites W2166550586 @default.
• W3215111505 cites W2273267066 @default.
• W3215111505 cites W2328410453 @default.
• W3215111505 cites W2344978273 @default.
• W3215111505 cites W2411505396 @default.
• W3215111505 cites W2475026798 @default.
• W3215111505 cites W2574695762 @default.
• W3215111505 cites W2623144351 @default.
• W3215111505 cites W2626234006 @default.
• W3215111505 cites W2754973711 @default.
• W3215111505 cites W2755504031 @default.
• W3215111505 cites W2772246919 @default.
• W3215111505 cites W2788468983 @default.
• W3215111505 cites W2795827520 @default.
• W3215111505 cites W2804390465 @default.
• W3215111505 cites W2885336082 @default.
• W3215111505 cites W2888888819 @default.
• W3215111505 cites W2892107476 @default.
• W3215111505 cites W2900782726 @default.
• W3215111505 cites W2902771169 @default.
• W3215111505 cites W2903457038 @default.
• W3215111505 cites W2903844485 @default.
• W3215111505 cites W2911658427 @default.
• W3215111505 cites W2912120394 @default.
• W3215111505 cites W2921675148 @default.
• W3215111505 cites W2924655035 @default.
• W3215111505 cites W2937307539 @default.
• W3215111505 cites W2946488372 @default.
• W3215111505 cites W2946533487 @default.
• W3215111505 cites W2973316378 @default.
• W3215111505 cites W2979670403 @default.
• W3215111505 cites W2982574415 @default.
• W3215111505 cites W2982683456 @default.
• W3215111505 cites W2989876225 @default.
• W3215111505 cites W2995118312 @default.
• W3215111505 cites W2995904755 @default.
• W3215111505 cites W3004278594 @default.
• W3215111505 cites W3009999522 @default.
• W3215111505 cites W3015029227 @default.
• W3215111505 cites W3022375425 @default.
• W3215111505 cites W3033646657 @default.
• W3215111505 cites W3039962640 @default.
• W3215111505 cites W3042778401 @default.
• W3215111505 cites W3044025582 @default.
• W3215111505 cites W3044334750 @default.
• W3215111505 cites W3044447231 @default.
• W3215111505 cites W3044588961 @default.
• W3215111505 cites W3047618013 @default.
• W3215111505 cites W3048301534 @default.
• W3215111505 cites W3085659227 @default.
• W3215111505 cites W3092607059 @default.
• W3215111505 cites W3093188829 @default.
• W3215111505 cites W3093213262 @default.
• W3215111505 cites W3098351838 @default.
• W3215111505 cites W3098949126 @default.
• W3215111505 cites W3102378350 @default.
• W3215111505 cites W3110653116 @default.
• W3215111505 cites W3116412482 @default.
• W3215111505 cites W3118589242 @default.
• W3215111505 cites W3118917667 @default.
• W3215111505 cites W3119523053 @default.
• W3215111505 cites W3125539506 @default.
• W3215111505 cites W3132798068 @default.
• W3215111505 cites W3136301451 @default.
• W3215111505 cites W3137894093 @default.
• W3215111505 cites W3138828276 @default.
• W3215111505 cites W3140760072 @default.
• W3215111505 cites W3141812064 @default.
• W3215111505 cites W3153418506 @default.
• W3215111505 cites W3157392264 @default.
• W3215111505 cites W3178803406 @default.
• W3215111505 cites W3181234600 @default.
• W3215111505 cites W3184661270 @default.
• W3215111505 cites W3189617125 @default.
• W3215111505 cites W3199395175 @default.
• W3215111505 cites W3202409837 @default.
• W3215111505 cites W3202980828 @default.
• W3215111505 cites W3203516197 @default.
• W3215111505 cites W3204492774 @default.
• W3215111505 cites W4252553827 @default.
• W3215111505 doi "https://doi.org/10.1002/cpt.2480" @default.
• W3215111505 hasPubMedId "https://pubmed.ncbi.nlm.nih.gov/34839524" @default.
• W3215111505 hasPublicationYear "2021" @default.

• next