TY - JOUR
T1 - The Danish metastatic melanoma database (DAMMED)
T2 - A nation-wide platform for quality assurance and research in real-world data on medical therapy in Danish melanoma patients
AU - Ellebaek, Eva
AU - Svane, Inge Marie
AU - Schmidt, Henrik
AU - Haslund, Charlotte Aaquist
AU - Donia, Marco
AU - Hoejberg, Lise
AU - Ruhlmann, Christina
AU - Guldbrandt, Louise Mahncke
AU - Køhler, Ulrich Heide
AU - Bastholt, Lars
N1 - Copyright © 2021 Elsevier Ltd. All rights reserved.
PY - 2021/8
Y1 - 2021/8
N2 - 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.
AB - 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.
KW - Adjuvant therapy
KW - Database structure
KW - Immunotherapy
KW - Metastatic melanoma
KW - Real-world evidence
KW - Targeted therapy
UR - http://www.scopus.com/inward/record.url?scp=85105330761&partnerID=8YFLogxK
U2 - 10.1016/j.canep.2021.101943
DO - 10.1016/j.canep.2021.101943
M3 - Journal article
C2 - 33962356
AN - SCOPUS:85105330761
SN - 1877-7821
VL - 73
JO - Cancer epidemiology
JF - Cancer epidemiology
M1 - 101943
ER -