Optimizing the Design and Analysis of Clinical Trials for Antibacterials Against Multidrug-resistant Organisms: A White Paper From COMBACTE's STAT-Net
| Autor: | Esther Bettiol, Harriet Sommer, Stavros Nikolakopoulos, Isaac Gravestock, Alasdair P. MacGowan, Ohad Amit, Jan Beyersmann, Alexandra McAleenan, Femke de Velde, Johan W. Mouton, Marlieke E. A. de Kraker, Aaron Dane, Andrew M. Lovering, Stéphan Juergen Harbarth, Jean-François Timsit, Martin Wolkewitz, Leonhard Held, Emmanuel Weiss, David Wilson, Teri Ashton |
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| Přispěvatelé: | Medical Microbiology & Infectious Diseases, Pharmacy, University of Zurich, de Kraker, Marlieke E A |
| Rok vydání: | 2018 |
| Předmět: |
0301 basic medicine
Microbiology (medical) medicine.medical_specialty randomized clinical trials Evidence-based practice Quality management 030106 microbiology Population 610 Medicine & health Analysis of clinical trials 2726 Microbiology (medical) law.invention 03 medical and health sciences 0302 clinical medicine Randomized controlled trial law Drug Resistance Multiple Bacterial medicine antibacterial drug development Humans 030212 general & internal medicine Intensive care medicine education multidrug-resistant organisms Randomized Controlled Trials as Topic ddc:616 education.field_of_study Evidence-Based Medicine Surrogate endpoint business.industry Clinical study design Bayes Theorem Evidence-based medicine Bacterial Infections 10060 Epidemiology Biostatistics and Prevention Institute (EBPI) 2725 Infectious Diseases clinical trial design 3. Good health Anti-Bacterial Agents Viewpoints Infectious Diseases Research Design Data Interpretation Statistical novel biostatistical methods business |
| Zdroj: | Clinical Infectious Diseases, 67(12), 1922-1931. Oxford University Press Clinical Infectious Diseases: An Official Publication of the Infectious Diseases Society of America Clinical Infectious Diseases (2018) de Kraker, M EA, Sommer, H, de Velde, F, Gravestock, I, Weiss, E, McAleenan, A, Nikolakopoulos, S, Amit, O, Ashton, T, Beyersmann, J, Held, L, Lovering, A M, MacGowan, A, Mouton, J W, Timsit, J-F, Wilson, D, Wolkewitz, M, Bettiol, E, Dane, A & Harbarth, S 2018, ' Optimizing the design and analysis of clinical trials for antibacterials against multidrug-resistant organisms : a white paper from COMBACTE's STAT-Net ', Clinical Infectious Diseases . https://doi.org/10.1093/cid/ciy516 |
| ISSN: | 1058-4838 |
| Popis: | Innovations are urgently required for clinical development of antibacterials against multidrug-resistant organisms. Therefore, a European, public-private working group (STAT-Net; part of Combatting Bacterial Resistance in Europe [COMBACTE]), has reviewed and tested several innovative trials designs and analytical methods for randomized clinical trials, which has resulted in 8 recommendations. The first 3 focus on pharmacokinetic and pharmacodynamic modeling, emphasizing the pertinence of population-based pharmacokinetic models, regulatory procedures for the reassessment of old antibiotics, and rigorous quality improvement. Recommendations 4 and 5 address the need for more sensitive primary end points through the use of rank-based or time-dependent composite end points. Recommendation 6 relates to the applicability of hierarchical nested-trial designs, and the last 2 recommendations propose the incorporation of historical or concomitant trial data through Bayesian methods and/or platform trials. Although not all of these recommendations are directly applicable, they provide a solid, evidence-based approach to develop new, and established, antibacterials and address this public health challenge. Innovations are urgently required for clinical development of antibiotics against multidrug-resistant organisms. COMBACTE-STAT-Net provides recommendations for improved pharmacokinetic-pharmacodynamic modeling, more sensitive primary end points, hierarchical nested-trial designs, and use of historical/concomitant trial data through Bayesian methods and/or platform trials. |
| Databáze: | OpenAIRE |
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