Why has model-informed precision dosing not yet become common clinical reality?: Lessons from the past and a roadmap for the future

Adam Darwich; Kayode Ogungbenro; Alexander A. Vinks; J. Robert Powell; Jean-Luc Reny; Niloufar Marsousi; Youssef Daali; David Fairman; Jack  Cook; Lawrence J. Lesko; Jeannine S. McCune; Catherijne A.J.  Knibbe; Saskia N.  de Wildt; J. Steven Leeder; Michael N. Neely; Athena F. Zuppa; Paolo Vicini; Leon Aarons; Trevor N. Johnson; James Boiani; Amin Rostami-Hodjegan

doi:10.1002/cpt.659

Why has model-informed precision dosing not yet become common clinical reality? Lessons from the past and a roadmap for the future

Adam Darwich, Kayode Ogungbenro, Alexander A. Vinks, J. Robert Powell, Jean-Luc Reny, Niloufar Marsousi, Youssef Daali, David Fairman, Jack Cook, Lawrence J. Lesko, Jeannine S. McCune, Catherijne A.J. Knibbe, Saskia N. de Wildt, J. Steven Leeder, Michael N. Neely, Athena F. Zuppa, Paolo Vicini, Leon Aarons, Trevor N. Johnson, James BoianiAmin Rostami-Hodjegan

Pharmacy

Research output: Contribution to journal › Article › peer-review

1302 Downloads (Pure)

Abstract

Patient groups prone to polypharmacy and special subpopulations are susceptible to suboptimal treatment. Refined dosing in special populations is imperative to improve therapeutic response and/or lowering the risk of toxicity. Model-informed precision dosing (MIPD) may improve treatment outcomes by achieving the optimal dose for an individual patient. There is however relatively little published evidence of large-scale utility and impact of MIPD, where it is often implemented as local collaborative efforts between academia and healthcare.

This manuscript highlights some successful applications of bringing MIPD to clinical care and proposes strategies for wider integration of MIPD in healthcare.

Considerations are brought up herein that will need addressing to see MIPD become ‘widespread clinical practice': amongst those, wider interdisciplinary collaborations and the necessity for further evidence-based efficacy and cost-benefit analysis of MIPD in healthcare. The implications of MIPD on regulatory policies and pharmaceutical development are also discussed as part of the roadmap

Original language	English
Journal	Clinical Pharmacology & Therapeutics
Early online date	9 Feb 2017
DOIs	https://doi.org/10.1002/cpt.659
Publication status	Published - 2017

Access to Document

10.1002/cpt.659

Darwich_et_al-2017-CPT_ACCEPTEDAccepted author manuscript, 1.67 MB

Modernising Drug Development Practices for Precision Dosing in Diverse Patient Populations
Rostami-Hochaghan, A. (Participant), Aarons, L. (Participant), Galetin, A. (Participant), Barber, J. (Participant), Ogungbenro, K. (Participant) & (Participant)
Impact: Technological impacts, Economic, Health and wellbeing, Policy

Cite this

Darwich, A., Ogungbenro, K., Vinks, A. A., Powell, J. R., Reny, J.-L., Marsousi, N., Daali, Y., Fairman, D., Cook, J., Lesko, L. J., McCune, J. S., Knibbe, C. A. J., de Wildt, S. N., Leeder, J. S., Neely, M. N., Zuppa, A. F., Vicini, P., Aarons, L., Johnson, T. N., ... Rostami-Hodjegan, A. (2017). Why has model-informed precision dosing not yet become common clinical reality? Lessons from the past and a roadmap for the future. Clinical Pharmacology & Therapeutics. https://doi.org/10.1002/cpt.659

@article{56aab6a9ff7a4ef3ab03d87079c1d9a7,

title = "Why has model-informed precision dosing not yet become common clinical reality?: Lessons from the past and a roadmap for the future",

abstract = "Patient groups prone to polypharmacy and special subpopulations are susceptible to suboptimal treatment. Refined dosing in special populations is imperative to improve therapeutic response and/or lowering the risk of toxicity. Model-informed precision dosing (MIPD) may improve treatment outcomes by achieving the optimal dose for an individual patient. There is however relatively little published evidence of large-scale utility and impact of MIPD, where it is often implemented as local collaborative efforts between academia and healthcare.This manuscript highlights some successful applications of bringing MIPD to clinical care and proposes strategies for wider integration of MIPD in healthcare.Considerations are brought up herein that will need addressing to see MIPD become {\textquoteleft}widespread clinical practice': amongst those, wider interdisciplinary collaborations and the necessity for further evidence-based efficacy and cost-benefit analysis of MIPD in healthcare. The implications of MIPD on regulatory policies and pharmaceutical development are also discussed as part of the roadmap",

author = "Adam Darwich and Kayode Ogungbenro and Vinks, {Alexander A.} and Powell, {J. Robert} and Jean-Luc Reny and Niloufar Marsousi and Youssef Daali and David Fairman and Jack Cook and Lesko, {Lawrence J.} and McCune, {Jeannine S.} and Knibbe, {Catherijne A.J.} and {de Wildt}, {Saskia N.} and Leeder, {J. Steven} and Neely, {Michael N.} and Zuppa, {Athena F.} and Paolo Vicini and Leon Aarons and Johnson, {Trevor N.} and James Boiani and Amin Rostami-Hodjegan",

year = "2017",

doi = "10.1002/cpt.659",

language = "English",

journal = "Clinical Pharmacology & Therapeutics",

issn = "0009-9236",

publisher = "Springer Nature",

}

Darwich, A, Ogungbenro, K, Vinks, AA, Powell, JR, Reny, J-L, Marsousi, N, Daali, Y, Fairman, D, Cook, J, Lesko, LJ, McCune, JS, Knibbe, CAJ, de Wildt, SN, Leeder, JS, Neely, MN, Zuppa, AF, Vicini, P, Aarons, L, Johnson, TN, Boiani, J & Rostami-Hodjegan, A 2017, 'Why has model-informed precision dosing not yet become common clinical reality? Lessons from the past and a roadmap for the future', Clinical Pharmacology & Therapeutics. https://doi.org/10.1002/cpt.659

TY - JOUR

T1 - Why has model-informed precision dosing not yet become common clinical reality?

T2 - Lessons from the past and a roadmap for the future

AU - Darwich, Adam

AU - Ogungbenro, Kayode

AU - Vinks, Alexander A.

AU - Powell, J. Robert

AU - Reny, Jean-Luc

AU - Marsousi, Niloufar

AU - Daali, Youssef

AU - Fairman, David

AU - Cook, Jack

AU - Lesko, Lawrence J.

AU - McCune, Jeannine S.

AU - Knibbe, Catherijne A.J.

AU - de Wildt, Saskia N.

AU - Leeder, J. Steven

AU - Neely, Michael N.

AU - Zuppa, Athena F.

AU - Vicini, Paolo

AU - Aarons, Leon

AU - Johnson, Trevor N.

AU - Boiani, James

AU - Rostami-Hodjegan, Amin

PY - 2017

Y1 - 2017

N2 - Patient groups prone to polypharmacy and special subpopulations are susceptible to suboptimal treatment. Refined dosing in special populations is imperative to improve therapeutic response and/or lowering the risk of toxicity. Model-informed precision dosing (MIPD) may improve treatment outcomes by achieving the optimal dose for an individual patient. There is however relatively little published evidence of large-scale utility and impact of MIPD, where it is often implemented as local collaborative efforts between academia and healthcare.This manuscript highlights some successful applications of bringing MIPD to clinical care and proposes strategies for wider integration of MIPD in healthcare.Considerations are brought up herein that will need addressing to see MIPD become ‘widespread clinical practice': amongst those, wider interdisciplinary collaborations and the necessity for further evidence-based efficacy and cost-benefit analysis of MIPD in healthcare. The implications of MIPD on regulatory policies and pharmaceutical development are also discussed as part of the roadmap

AB - Patient groups prone to polypharmacy and special subpopulations are susceptible to suboptimal treatment. Refined dosing in special populations is imperative to improve therapeutic response and/or lowering the risk of toxicity. Model-informed precision dosing (MIPD) may improve treatment outcomes by achieving the optimal dose for an individual patient. There is however relatively little published evidence of large-scale utility and impact of MIPD, where it is often implemented as local collaborative efforts between academia and healthcare.This manuscript highlights some successful applications of bringing MIPD to clinical care and proposes strategies for wider integration of MIPD in healthcare.Considerations are brought up herein that will need addressing to see MIPD become ‘widespread clinical practice': amongst those, wider interdisciplinary collaborations and the necessity for further evidence-based efficacy and cost-benefit analysis of MIPD in healthcare. The implications of MIPD on regulatory policies and pharmaceutical development are also discussed as part of the roadmap

U2 - 10.1002/cpt.659

DO - 10.1002/cpt.659

M3 - Article

SN - 0009-9236

JO - Clinical Pharmacology & Therapeutics

JF - Clinical Pharmacology & Therapeutics

ER -

Why has model-informed precision dosing not yet become common clinical reality? Lessons from the past and a roadmap for the future

Abstract

Access to Document

Fingerprint

Impacts

Modernising Drug Development Practices for Precision Dosing in Diverse Patient Populations

Cite this