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Optimizing the design and analysis of clinical trials for antibacterials against multidrug-resistant organisms: a white paper from COMBACTE's STAT-Net

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Optimizing the design and analysis of clinical trials for antibacterials against multidrug-resistant organisms : a white paper from COMBACTE's STAT-Net. / de Kraker, Marlieke EA; Sommer, Harriet; de Velde, Femke; Gravestock, Isaac; Weiss, Emmanuel; McAleenan, Alexandra; Nikolakopoulos, Stavros; Amit, Ohad; Ashton, Teri; Beyersmann, Jan; Held, Leonhard; Lovering, Andrew M; MacGowan, Alasdair; Mouton, Johan W; Timsit, Jean-François; Wilson, David; Wolkewitz, Martin; Bettiol, Esther; Dane, Aaron; Harbarth, Stephan.

In: Clinical Infectious Diseases, 13.08.2018.

Research output: Contribution to journalArticle

Harvard

de Kraker, MEA, Sommer, H, de Velde, F, Gravestock, I, Weiss, E, McAleenan, A, Nikolakopoulos, S, Amit, O, Ashton, T, Beyersmann, J, Held, L, Lovering, AM, MacGowan, A, Mouton, JW, 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

APA

de Kraker, M. EA., Sommer, H., de Velde, F., Gravestock, I., Weiss, E., McAleenan, 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, [ciy516]. https://doi.org/10.1093/cid/ciy516

Vancouver

Author

de Kraker, Marlieke EA ; Sommer, Harriet ; de Velde, Femke ; Gravestock, Isaac ; Weiss, Emmanuel ; McAleenan, Alexandra ; Nikolakopoulos, Stavros ; Amit, Ohad ; Ashton, Teri ; Beyersmann, Jan ; Held, Leonhard ; Lovering, Andrew M ; MacGowan, Alasdair ; Mouton, Johan W ; Timsit, Jean-François ; Wilson, David ; Wolkewitz, Martin ; Bettiol, Esther ; Dane, Aaron ; Harbarth, Stephan. / Optimizing the design and analysis of clinical trials for antibacterials against multidrug-resistant organisms : a white paper from COMBACTE's STAT-Net. In: Clinical Infectious Diseases. 2018.

Bibtex

@article{51e9f86613974c51a2b8ff83dd0299ef,
title = "Optimizing the design and analysis of clinical trials for antibacterials against multidrug-resistant organisms: a white paper from COMBACTE's STAT-Net",
abstract = "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.",
keywords = "randomized clinical trials, multidrug-resistant organisms, novel biostatistical methods, clinical trial design, antibacterial drug development",
author = "{de Kraker}, {Marlieke EA} and Harriet Sommer and {de Velde}, Femke and Isaac Gravestock and Emmanuel Weiss and Alexandra McAleenan and Stavros Nikolakopoulos and Ohad Amit and Teri Ashton and Jan Beyersmann and Leonhard Held and Lovering, {Andrew M} and Alasdair MacGowan and Mouton, {Johan W} and Jean-Fran{\cc}ois Timsit and David Wilson and Martin Wolkewitz and Esther Bettiol and Aaron Dane and Stephan Harbarth",
year = "2018",
month = "8",
day = "13",
doi = "10.1093/cid/ciy516",
language = "English",
journal = "Clinical Infectious Diseases",
issn = "1058-4838",
publisher = "Oxford University Press",

}

RIS - suitable for import to EndNote

TY - JOUR

T1 - Optimizing the design and analysis of clinical trials for antibacterials against multidrug-resistant organisms

T2 - a white paper from COMBACTE's STAT-Net

AU - de Kraker, Marlieke EA

AU - Sommer, Harriet

AU - de Velde, Femke

AU - Gravestock, Isaac

AU - Weiss, Emmanuel

AU - McAleenan, Alexandra

AU - Nikolakopoulos, Stavros

AU - Amit, Ohad

AU - Ashton, Teri

AU - Beyersmann, Jan

AU - Held, Leonhard

AU - Lovering, Andrew M

AU - MacGowan, Alasdair

AU - Mouton, Johan W

AU - Timsit, Jean-François

AU - Wilson, David

AU - Wolkewitz, Martin

AU - Bettiol, Esther

AU - Dane, Aaron

AU - Harbarth, Stephan

PY - 2018/8/13

Y1 - 2018/8/13

N2 - 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.

AB - 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.

KW - randomized clinical trials

KW - multidrug-resistant organisms

KW - novel biostatistical methods

KW - clinical trial design

KW - antibacterial drug development

U2 - 10.1093/cid/ciy516

DO - 10.1093/cid/ciy516

M3 - Article

JO - Clinical Infectious Diseases

JF - Clinical Infectious Diseases

SN - 1058-4838

M1 - ciy516

ER -