HCCAP comment ltr FDA 100106 reformat 1006

Hepatitis C HCCAP October 1, 2006 Food and Drug Administration Division of Dockets Management (HFA-305) 5630 Fishers Lane, Rm. 1061 Rockville, MD 20852 RE: Antiviral Drugs Advisory Committee Meeting – Development of Products for Treatment of Chronic Hepatitis C Dear Advisory Committee Members, The Hepatitis C Caring Ambassadors Program, a national nonprofit hepatitis C advocacy organization, respectfully submits the following comments and suggestions, which represent our current position with respect to the clinical development of products for the treatment of chronic hepatitis C. Comments are presented in accordance with the stated issues to be discussed at the upcoming meeting on October 19 and 20, 2006. Identification of Appropriate Control Arms I. Therapeutic Exploratory Trials (Phase II) In cases where an experimental therapeutic is being tested in combination with other therapeutics, we strongly advocate for the use of at least a two-arm, parallel comparison design (active control group) with rigorous matching and randomization protocols. Randomization protocols should be designed such that breaches of randomization are minimized. Matching procedures should take into account known potential confounders to optimize the probability of detecting therapeutic efficacy, should it exist, and to prevent erroneous exclusion of the same. In accordance with Article 29 of the Helsinki Declaration of 2004, we ...