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Real-world evidence...
Real-world evidence contributions to European medicines agency's safety and efficacy evaluations of oncology targeted therapies between 2018-2022
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- Derksen, J. W. G. (author)
- Dept. Julius Center for Health Sciences and Primary Care, UMC-University Medical Center Utrecht, Utrecht, Netherlands
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- Branco, D. Martins (author)
- Clinical Trials Support Unit, Institute Jules Bordet, Brussels, Belgium
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- Pellat, A. (author)
- Medical Oncology, Hopital Saint-Antoine, Paris, France
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- Van Nassau, S. C. M. W. (author)
- Medical Oncology, UMC - University Medical Center Utrecht, Utrecht, Netherlands
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- Valachis, A., 1984- (author)
- Region Örebro län,Örebro universitet, Institutionen för medicinska vetenskaper,Dept. of Oncology
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- Aggarwal, A. (author)
- Institute of Cancer Policy, KCL - King's College London, London, UK
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- Koopman, M. (author)
- Medical Oncology, UMC - University Medical Center Utrecht, Utrecht, Netherlands
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- Pentheroudakis, G. (author)
- Scientific and Medical Division, ESMO - European Society for Medical Oncology, Lugano, Switzerland
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- Castelo-Branco, L. (author)
- Scientific and Medical Division, ESMO - European Society for Medical Oncology, Lugano, Switzerland
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- Delaloge, S. (author)
- Breast Oncology Department, Institut Gustave Roussy, Villejuif, France
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Dept Julius Center for Health Sciences and Primary Care, UMC-University Medical Center Utrecht, Utrecht, Netherlands Clinical Trials Support Unit, Institute Jules Bordet, Brussels, Belgium (creator_code:org_t)
- Elsevier, 2023
- 2023
- English.
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In: Annals of Oncology. - : Elsevier. - 0923-7534 .- 1569-8041. ; 34:Suppl. 2, s. S930-S930
- Related links:
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https://urn.kb.se/re...
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https://doi.org/10.1...
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Abstract
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- 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...
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Cancer och onkologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Cancer and Oncology (hsv//eng)
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- vet (subject category)
- art (subject category)
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Derksen, J. W. G ...
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Branco, D. Marti ...
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Pellat, A.
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Van Nassau, S. C ...
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Valachis, A., 19 ...
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Aggarwal, A.
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Koopman, M.
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Pentheroudakis, ...
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Castelo-Branco, ...
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Delaloge, S.
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- About the subject
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Clinical Medicin ...
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and Cancer and Oncol ...
- Articles in the publication
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Annals of Oncolo ...
- By the university
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Örebro University