Data monitoring committees-state of the art and perspectives for the future
BACKGROUND: The classic randomized and controlled clinical trial is facing new challenges with complex study designs and disease interception concepts. For this reason, data monitoring committees (DMCs) can take on a central function if professionally integrated into the methodical procedure of clinical trials. On this basis, the responsible competent authority and the responsible ethics committee have to verify the substantial charter document in the implicit/explicit approval procedure reflecting the working process of the independent committee.
OBJECTIVES: The frequencies and conditions under which DMCs are used in clinical trials was investigated.
METHODS: The database of the Federal Institute for Drugs and Medical Devices (BfArM) was the basis for statistical analysis concerning the frequency of implementation of data monitoring committees with different criteria over an observation period of more than 15 years.
RESULTS: In total, 4152 DMCs have been used in 14,135 clinical trials with drugs. The independent expert committee was mostly integrated by commercial sponsors in phase III of the clinical development. The ethics committees were involved with different absolute frequencies.
DISCUSSION: Sponsors demonstrate an increasing willingness to integrate DMCs in the methodical conduct of clinical trials especially in the case of new study designs. DMCs could be an important scientific aid in order to assess the implications of coronavirus SARS-CoV‑2 on clinical trials.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2020 |
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| Erschienen: |
2020 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:63 |
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| Enthalten in: |
Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz - 63(2020), 12 vom: 28. Dez., Seite 1511-1518 |
| Sprache: |
Deutsch |
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| Weiterer Titel: |
Das Data Monitoring Committee – State of the Art und Perspektiven für die Zukunft |
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| Beteiligte Personen: |
Fischer, Thomas [VerfasserIn] |
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| Links: |
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| Themen: |
BfArM databank |
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| Anmerkungen: |
Date Completed 26.11.2020 Date Revised 10.01.2021 published: Print-Electronic Citation Status MEDLINE |
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| doi: |
10.1007/s00103-020-03212-w |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM314700951 |
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| 520 | |a BACKGROUND: The classic randomized and controlled clinical trial is facing new challenges with complex study designs and disease interception concepts. For this reason, data monitoring committees (DMCs) can take on a central function if professionally integrated into the methodical procedure of clinical trials. On this basis, the responsible competent authority and the responsible ethics committee have to verify the substantial charter document in the implicit/explicit approval procedure reflecting the working process of the independent committee | ||
| 520 | |a OBJECTIVES: The frequencies and conditions under which DMCs are used in clinical trials was investigated | ||
| 520 | |a METHODS: The database of the Federal Institute for Drugs and Medical Devices (BfArM) was the basis for statistical analysis concerning the frequency of implementation of data monitoring committees with different criteria over an observation period of more than 15 years | ||
| 520 | |a RESULTS: In total, 4152 DMCs have been used in 14,135 clinical trials with drugs. The independent expert committee was mostly integrated by commercial sponsors in phase III of the clinical development. The ethics committees were involved with different absolute frequencies | ||
| 520 | |a DISCUSSION: Sponsors demonstrate an increasing willingness to integrate DMCs in the methodical conduct of clinical trials especially in the case of new study designs. DMCs could be an important scientific aid in order to assess the implications of coronavirus SARS-CoV‑2 on clinical trials | ||
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| 650 | 4 | |a Statistical analysis | |
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