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Clinical drug development in epilepsy revisited: a proposal for a new paradigm streamlined using extrapolation

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Clinical drug development in epilepsy revisited: a proposal for a new paradigm streamlined using extrapolation. / Wadsworth, Ian; Jaki, Thomas Friedrich; Sills, Graeme J. et al.
In: CNS Drugs, Vol. 30, No. 11, 11.2016, p. 1011-1017.

Research output: Contribution to Journal/MagazineJournal articlepeer-review

Harvard

Wadsworth, I, Jaki, TF, Sills, GJ, Appleton, R, Cross, JH, Marson, AG, Martland, T, McLellan, A, Smith, PEM, Pellock, JM & Hampson, LV 2016, 'Clinical drug development in epilepsy revisited: a proposal for a new paradigm streamlined using extrapolation', CNS Drugs, vol. 30, no. 11, pp. 1011-1017. https://doi.org/10.1007/s40263-016-0383-y

APA

Wadsworth, I., Jaki, T. F., Sills, G. J., Appleton, R., Cross, J. H., Marson, A. G., Martland, T., McLellan, A., Smith, P. E. M., Pellock, J. M., & Hampson, L. V. (2016). Clinical drug development in epilepsy revisited: a proposal for a new paradigm streamlined using extrapolation. CNS Drugs, 30(11), 1011-1017. https://doi.org/10.1007/s40263-016-0383-y

Vancouver

Wadsworth I, Jaki TF, Sills GJ, Appleton R, Cross JH, Marson AG et al. Clinical drug development in epilepsy revisited: a proposal for a new paradigm streamlined using extrapolation. CNS Drugs. 2016 Nov;30(11):1011-1017. Epub 2016 Sept 13. doi: 10.1007/s40263-016-0383-y

Author

Bibtex

@article{01f646b7608c4d83bd7ede066f1a97ca,
title = "Clinical drug development in epilepsy revisited: a proposal for a new paradigm streamlined using extrapolation",
abstract = "Data from clinical trials in adults, extrapolated to predict benefits in paediatric patients, could result in fewer or smaller trials being required to obtain a new drug licence for paediatrics. This article outlines the place of such extrapolation in the development of drugs for use in paediatric epilepsies. Based on consensus expert opinion, a proposal is presented for a new paradigm for the clinical development of drugs for focal epilepsies. Phase I data should continue to be collected in adults, and phase II and III trials should simultaneously recruit adults and paediatric patients aged above 2 years. Drugs would be provisionally licensed for children subject to phase IV collection of neurodevelopmental safety data in this age group. A single programme of trials would suffice to license the drug for use as either adjunctive therapy or monotherapy. Patients, clinicians and sponsors would all benefit from this new structure through cost reduction and earlier access to novel treatments. Further work is needed to elicit the views of patients, their parents and guardians as appropriate, regulatory authorities and bodies such as the National Institute for Health and Care Excellence (UK).",
author = "Ian Wadsworth and Jaki, {Thomas Friedrich} and Sills, {Graeme J.} and Richard Appleton and Cross, {J. Helen} and Marson, {Anthony G.} and Timothy Martland and Ailsa McLellan and Smith, {Philip E. M.} and Pellock, {John M.} and Hampson, {Lisa Victoria}",
year = "2016",
month = nov,
doi = "10.1007/s40263-016-0383-y",
language = "English",
volume = "30",
pages = "1011--1017",
journal = "CNS Drugs",
issn = "1172-7047",
publisher = "ADIS INT LTD",
number = "11",

}

RIS

TY - JOUR

T1 - Clinical drug development in epilepsy revisited

T2 - a proposal for a new paradigm streamlined using extrapolation

AU - Wadsworth, Ian

AU - Jaki, Thomas Friedrich

AU - Sills, Graeme J.

AU - Appleton, Richard

AU - Cross, J. Helen

AU - Marson, Anthony G.

AU - Martland, Timothy

AU - McLellan, Ailsa

AU - Smith, Philip E. M.

AU - Pellock, John M.

AU - Hampson, Lisa Victoria

PY - 2016/11

Y1 - 2016/11

N2 - Data from clinical trials in adults, extrapolated to predict benefits in paediatric patients, could result in fewer or smaller trials being required to obtain a new drug licence for paediatrics. This article outlines the place of such extrapolation in the development of drugs for use in paediatric epilepsies. Based on consensus expert opinion, a proposal is presented for a new paradigm for the clinical development of drugs for focal epilepsies. Phase I data should continue to be collected in adults, and phase II and III trials should simultaneously recruit adults and paediatric patients aged above 2 years. Drugs would be provisionally licensed for children subject to phase IV collection of neurodevelopmental safety data in this age group. A single programme of trials would suffice to license the drug for use as either adjunctive therapy or monotherapy. Patients, clinicians and sponsors would all benefit from this new structure through cost reduction and earlier access to novel treatments. Further work is needed to elicit the views of patients, their parents and guardians as appropriate, regulatory authorities and bodies such as the National Institute for Health and Care Excellence (UK).

AB - Data from clinical trials in adults, extrapolated to predict benefits in paediatric patients, could result in fewer or smaller trials being required to obtain a new drug licence for paediatrics. This article outlines the place of such extrapolation in the development of drugs for use in paediatric epilepsies. Based on consensus expert opinion, a proposal is presented for a new paradigm for the clinical development of drugs for focal epilepsies. Phase I data should continue to be collected in adults, and phase II and III trials should simultaneously recruit adults and paediatric patients aged above 2 years. Drugs would be provisionally licensed for children subject to phase IV collection of neurodevelopmental safety data in this age group. A single programme of trials would suffice to license the drug for use as either adjunctive therapy or monotherapy. Patients, clinicians and sponsors would all benefit from this new structure through cost reduction and earlier access to novel treatments. Further work is needed to elicit the views of patients, their parents and guardians as appropriate, regulatory authorities and bodies such as the National Institute for Health and Care Excellence (UK).

U2 - 10.1007/s40263-016-0383-y

DO - 10.1007/s40263-016-0383-y

M3 - Journal article

VL - 30

SP - 1011

EP - 1017

JO - CNS Drugs

JF - CNS Drugs

SN - 1172-7047

IS - 11

ER -