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 - Publisher Copyright: © 2021 Elsevier Ltd

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

U2 - 10.1016/j.canep.2021.101943

DO - 10.1016/j.canep.2021.101943

M3 - Journal article

C2 - 33962356

AN - SCOPUS:85105330761

VL - 73

JO - Cancer Epidemiology

JF - Cancer Epidemiology

SN - 1877-7821

M1 - 101943

ER -