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Sökning: WFRF:(Pentheroudakis G.) > (2023) > Real-world evidence...

LIBRIS Formathandbok  (Information om MARC21)
FältnamnIndikatorerMetadata
00004314naa a2200385 4500
001oai:DiVA.org:oru-110150
003SwePub
008231211s2023 | |||||||||||000 ||eng|
0247 a https://urn.kb.se/resolve?urn=urn:nbn:se:oru:diva-1101502 URI
0247 a https://doi.org/10.1016/j.annonc.2023.09.26562 DOI
040 a (SwePub)oru
041 a engb eng
042 9 SwePub
072 7a vet2 swepub-contenttype
072 7a art2 swepub-publicationtype
1001 a Derksen, J. W. G.u Dept. Julius Center for Health Sciences and Primary Care, UMC-University Medical Center Utrecht, Utrecht, Netherlands4 aut
2451 0a Real-world evidence contributions to European medicines agency's safety and efficacy evaluations of oncology targeted therapies between 2018-2022
264 1b Elsevier,c 2023
338 a print2 rdacarrier
520 a Background: While Real-world Evidence (RWE) has documented value for safety monitoring and disease epidemiology, its objective contribution to safety and efficacy evaluations for regulatory purposes is still unclear. Here, we aim to describe the prevalence and type of RWE considered by European Medicines Agency (EMA) as contribution to efficacy and safety-related evidence generation among approved oncology targeted therapies...Methods: On March 10, 2023, we screened the medicines listing of EMA to identify all anti-cancer targeted therapies for solid malignancies with a decision date (initial marketing authorizations and extension of indications) between 2018-2022. We screened the European public assessment reports (EPARs) using a standardized approach to collect data on RWE. When generated pre-authorization, the RWE contribution to the final regulatory decision was classified as definitive, supportive, or non-supportive. For...Results: Out of a total of 1976 medicines, we identified 55 oncology targeted therapies, corresponding to 75 EPARs (indications), which are described in the table. The use of RWE in regulatory deliberations occurred in 24/75 (32%) EPARs, increasing from 30% in 2018-2020, to 34% in 2021-2022. Pre-authorization RWE was described in 20/24 (83%) EPARs, among which none were definitive, 8 RWE studies (in 7 EPARs) non-supportive, and 20 RWE studies (in 15 EPARs) were supportive of the decision. Published RWE...Conclusions: Over the past 5 years, RWE involvement in the approval of oncology targeted therapies in Europe tends to increase, with the majority being supportive for EMA regulatory decision making complementary to traditional clinical trials...
650 7a MEDICIN OCH HÄLSOVETENSKAPx Klinisk medicinx Cancer och onkologi0 (SwePub)302032 hsv//swe
650 7a MEDICAL AND HEALTH SCIENCESx Clinical Medicinex Cancer and Oncology0 (SwePub)302032 hsv//eng
7001 a Branco, D. Martinsu Clinical Trials Support Unit, Institute Jules Bordet, Brussels, Belgium4 aut
7001 a Pellat, A.u Medical Oncology, Hopital Saint-Antoine, Paris, France4 aut
7001 a Van Nassau, S. C. M. W.u Medical Oncology, UMC - University Medical Center Utrecht, Utrecht, Netherlands4 aut
7001 a Valachis, A.,d 1984-u Region Örebro län,Örebro universitet, Institutionen för medicinska vetenskaper,Dept. of Oncology4 aut0 (Swepub:oru)asvs
7001 a Aggarwal, A.u Institute of Cancer Policy, KCL - King's College London, London, UK4 aut
7001 a Koopman, M.u Medical Oncology, UMC - University Medical Center Utrecht, Utrecht, Netherlands4 aut
7001 a Pentheroudakis, G.u Scientific and Medical Division, ESMO - European Society for Medical Oncology, Lugano, Switzerland4 aut
7001 a Castelo-Branco, L.u Scientific and Medical Division, ESMO - European Society for Medical Oncology, Lugano, Switzerland4 aut
7001 a Delaloge, S.u Breast Oncology Department, Institut Gustave Roussy, Villejuif, France4 aut
7102 a Dept. Julius Center for Health Sciences and Primary Care, UMC-University Medical Center Utrecht, Utrecht, Netherlandsb Clinical Trials Support Unit, Institute Jules Bordet, Brussels, Belgium4 org
7730 t Annals of Oncologyd : Elsevierg 34:Suppl. 2, s. S930-S930q 34:Suppl. 2<S930-S930x 0923-7534x 1569-8041
8564 8u https://urn.kb.se/resolve?urn=urn:nbn:se:oru:diva-110150
8564 8u https://doi.org/10.1016/j.annonc.2023.09.2656

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