Accelerating drug development through collaboration: the Hepatitis C Drug Development Advisory Group.

ACCEPTED ARTICLE PREVIEW

Accelerating Drug Development through Collaboration: The Hepatitis C Drug Development Advisory Group (HCV DrAG)

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Courtney Hutchison, Ann Kwong, Stuart Ray, Kimberly Struble, Tracy Swan, Veronica Miller

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Cite this article as: Courtney Hutchison, Ann Kwong, Stuart Ray, Kimberly Struble, Tracy Swan, Veronica Miller, Accelerating Drug Development through Collaboration: The Hepatitis C Drug Development Advisory Group (HCV DrAG), Clinical Pharmacology & Therapeutics accepted article preview online 22 May 2014; doi:10.1038/clpt.2014.113

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This is a PDF file of an unedited peer-reviewed manuscript that has been accepted for publication. NPG is providing this early version of the manuscript as a service to our customers. The manuscript will undergo copyediting, typesetting and a proof review before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers apply.

Received 16 22 May 2014

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© 2014 American Society for Clinical Pharmacology and Therapeutics. All rights reserved

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© 2014 American Society of Clinical Pharmacology and Therapeutics. All rights reserved


















Topic Clinical trial design

Issue Need to adapt to new data emerging from DAA trials

Process Convened open meetings with FDA and EMA to discuss novel approaches to clinical trial design

Outcome Consensus on the use of historic controls, helping to avoid the requirement for 24 or 48 week of P/R [presented at 2010 public/open meeting: Advancing HCV Drug Development: A Collaborative Approach]

Drug resistance analysis and interpretation

Need for standardization

Published a manuscript with consensus guidelines on drug resistance terminology, assays, and reference sequences [Kwong et al 2011]

HCV RNA assays and RGT

Need to standardize LLOQ and LLOD values for RGT, end-of-treatment, and SVR endpoints in clinical trials

Fostered discussion through sequence analysis and phenotype analysis working groups Special FDA analysis discussed with HCV DrAG members

DAA and RGT nomenclature

Need to standardize nomenclature for RGT

Fostered discussion through a nomenclature working group

Published a manuscript with consensus terminology [Wedemeyer et al 2012]

Drug resistance information

Need for access to organized drug resistance information

Fostered discussion through sequence analysis and phenotype analysis working groups

Published consensus on the inclusion of mutations and substitutions seen in clinical trials in a comprehensive and standardized database [HCV Phenotype Working Group 2012]

Special population

Need for people with bleeding disorders to obtain access to interferon-free clinical trials

Convened a special meeting to discuss access to ongoing trials and population-specific trials

Published consensus on revising clinical trial design for the treatment of HCV in people with bleeding disorders [Lairmore et al, manuscript in preparation]

Published consensus recommendations [Harrington et al 2012; Lontok et al 2012]


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Figure 1

© 2014 American Society for Clinical Pharmacology and Therapeutics. All rights reserved

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