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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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]
Accelerating drug development through collaboration: the Hepatitis C Drug Development Advisory Group.
Over the past decade, landmark collaboration between regulatory agencies, pharmaceutical companies, academia, and patient community representatives ha...