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Hep C Discussion Forum -> Clinical Trial Participants -> Forums Opportunity to give input to FDA HCV Treatment Guidelines
Post Info TOPIC: Forums Opportunity to give input to FDA HCV Treatment Guidelines
Matt Chris


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Forums Opportunity to give input to FDA HCV Treatment Guidelines
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Hey all

We have an opportunity to give written input to the FDA regarding HCV treatment from the viewpoint of the patient in the future treatments with DAA's. This our chance to give real world input from our standpoint not just the drugs company's. If you ever wished or wanted them to consider your viewpoint this is your opportunity to be a advocate for your side. Speak up and let your voice be heard.

The document is called :

Guidance for Industry Chronic Hepatitis C Virus Infection:
Developing Direct-Acting Antiviral Drugs for Treatment 
 
The first link will get you to the FDA page and the second the actual document 
 
Its a lot of reading but this is a draft and they are looking for input from the Drug company's, patients and trial participants. I actually called and talked to Kimberly Struble who works at the Division of Antiviral Drug Products, she confirmed that the FDA is concerned about how all the new DAA's are working in currents regiments and re-treatment of relapsed patients and this new draft will go a long way in giving guidance to how the drug company's handle there HCV protocols in treatments and trials that include multiple DAA's and rescue approaches of relapsed patients during approved normal treatments and and all phase trials. 
 
I will be submitting a whole list of items to the draft from the viewpoint of the trial participants, because they need to hear how the the patient feels before during and after the trial.
 
Its not that I am not aware of the cost involved and its fortuitous nature but its the lack of training of the do's and don't s what if's and understanding the stress and psyche of the participants is very important to the success of every trial.
 
So remember Speak up and let your voice be heard.
 
matt
  
                                                                    

 



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Hep C Discussion Forum -> Clinical Trial Participants -> Forums Opportunity to give input to FDA HCV Treatment Guidelines
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