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Tytuł pozycji:

The Danish metastatic melanoma database (DAMMED): A nation-wide platform for quality assurance and research in real-world data on medical therapy in Danish melanoma patients.

Tytuł:
The Danish metastatic melanoma database (DAMMED): A nation-wide platform for quality assurance and research in real-world data on medical therapy in Danish melanoma patients.
Autorzy:
Ellebaek E; Center for Cancer Immune Therapy, Department of Oncology, Copenhagen University Hospital, Herlev and Gentofte, Herlev, Denmark. Electronic address: .
Svane IM; Center for Cancer Immune Therapy, Department of Oncology, Copenhagen University Hospital, Herlev and Gentofte, Herlev, Denmark.
Schmidt H; Department of Oncology, Aarhus University Hospital, Aarhus, Denmark.
Haslund CA; Department of Oncology, Aalborg University Hospital, Aalborg, Denmark.
Donia M; Center for Cancer Immune Therapy, Department of Oncology, Copenhagen University Hospital, Herlev and Gentofte, Herlev, Denmark.
Hoejberg L; Department of Oncology, Odense University Hospital, Odense, Denmark.
Ruhlmann C; Department of Oncology, Odense University Hospital, Odense, Denmark.
Guldbrandt LM; Department of Oncology, Aarhus University Hospital, Aarhus, Denmark.
Køhler UH; Department of Oncology, Odense University Hospital, Odense, Denmark.
Bastholt L; Department of Oncology, Odense University Hospital, Odense, Denmark.
Źródło:
Cancer epidemiology [Cancer Epidemiol] 2021 Aug; Vol. 73, pp. 101943. Date of Electronic Publication: 2021 May 04.
Typ publikacji:
Journal Article; Randomized Controlled Trial
Język:
English
Imprint Name(s):
Original Publication: Amsterdam : Elsevier
MeSH Terms:
Databases, Factual*
Melanoma*/drug therapy
Melanoma*/epidemiology
Melanoma*/pathology
Skin Neoplasms*/drug therapy
Skin Neoplasms*/epidemiology
Skin Neoplasms*/pathology
Denmark/epidemiology ; Humans ; Neoplasm Staging ; Quality Assurance, Health Care ; Randomized Controlled Trials as Topic
Contributed Indexing:
Keywords: Adjuvant therapy; Database structure; Immunotherapy; Metastatic melanoma; Real-world evidence; Targeted therapy
Entry Date(s):
Date Created: 20210507 Date Completed: 20210827 Latest Revision: 20210827
Update Code:
20240104
DOI:
10.1016/j.canep.2021.101943
PMID:
33962356
Czasopismo naukowe
Background: Clinical trials enroll patients with specific diseases based on certain pre-defined eligibility criteria. Disease registries are crucial to evaluate the efficacy and safety of new expensive oncology medicines in broad non-trial patient populations.
Methods: We provide detailed information on the structure, including variables, and the scientific results from a nation-wide Danish database covering advanced melanoma, illustrating the importance of continuous real-world data registration. Disease status and treatment-related information on all patients with American Joint Committee on Cancer (AJCC) 8th edition stage III or IV melanoma candidates to medical treatment in Denmark are prospectively registered in the Danish Metastatic Melanoma Database (DAMMED).
Results: By January 1st, 2021, DAMMED includes 4156 patients and 7420 treatment regimens. Response rates and survival data from published randomized clinical trial data are compared with real-world efficacy data from DAMMED and presented. Overall, nine independent manuscripts highlighting similarities and discrepancies between real-world and clinical trial results are already reported to date.
Conclusion: Nation-wide disease registries take into consideration the complexity of daily clinical practice. We show a concrete example of how disease registries can complement clinical trials' information, improving clinical practice, and support health-related technology assessment.
(Copyright © 2021 Elsevier Ltd. All rights reserved.)

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