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

Eva Ellebaek*, Inge Marie Svane, Henrik Schmidt, Charlotte Aaquist Haslund, Marco Donia, Lise Hoejberg, Christina Ruhlmann, Louise Mahncke Guldbrandt, Ulrich Heide Køhler, Lars Bastholt

*Kontaktforfatter for dette arbejde

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

Abstrakt

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.

OriginalsprogEngelsk
Artikelnummer101943
TidsskriftCancer Epidemiology
Vol/bind73
ISSN1877-7821
DOI
StatusUdgivet - aug. 2021

Bibliografisk note

Funding Information:
EE received honoraria for lectures and travel expenses from Bristol-Myers Squibb, MSD, Roche, Kyowa Kirin, and Pierre Fabre. IMS received honoraria for consultancies and lectures from Novartis, Roche, MSD, Bristol-Myers Squibb, and Pierre Fabre and restricted research grants from Novartis and BMS. HS received honoraria for lectures from Novartis, Roche, MSD, BMS, and Pierre Fabre and an unrestricted research grant from MSD. CAH received honoraria for lectures from MSD. MD received honoraria for lectures from Roche and Novartis and expenses to access to Online Educational Material from MSD. LB received honoraria for lectures from Novartis, Roche, MSD, BMS, and Pierre Fabre.

Fingeraftryk

Dyk ned i forskningsemnerne om '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'. Sammen danner de et unikt fingeraftryk.

Citationsformater