ArticleBundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz2020
[Data monitoring committees-state of the art and perspectives for the future].
Article in Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
backgroundThe 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.
objectivesThe frequencies and conditions under which DMCs are used in clinical trials was investigated.
methodsThe 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.
resultsIn 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.
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