Re: My journey in the gene modification study.

[Guest guest]

Larry and other interested members,Clinical trials must meet strict time-honored guidelines. They may or may not make sense WHEN you are a patient. The very eagerness to participate might confound a study since as a patient you have the added desire that trial works.Think of it this way: Even if you were selected as a patient, you are not guaranteed to get the "real" medication. The clinicians try to minimize all other factors, that way they can deal with the most basic question. Even if you are rejected in one phase of the study, there might be other phases left and they may not be so strict. Inform the researchers that you are willing to participate in later phases.Ultimately, we all benefit from these strict guidelines. Some studies allow for salvage (or

expanded access) therapies if they have already passed safety standards (this is another topic altogether). If you feel you may benefit from this, make a formal request to the researcher not to the intake person (they lack the power/authority to make this decision).One last word of consolation: These guidelines do not guarantee that the drug will not be withdrawn at a later date by the FDA mostly for safety reasons.Remember there are billions at stake and big hats on the line.

[Guest guest]

Many clinical trials have to be placebo-controlled and double-blinded (meaning neither the participant nor the clinicians running the trial know who is getting the real drug and who is getting a placebo until the study is complete). However, there are some clinical trials now for HIV/HCV coinfected individuals that give everyone the same drugs. For example, there are trials coming up that will compare the effectiveness of a 3-drug combination against the current standard of treatment (pegylated interferon plus Ribavirin) in both treatment-naive and treatment-experienced patients. The latter are those who had a viral relapse at the end of treatment with the 2-drug combo but are expected, statistically, to clear the virus with the 3-drug protocol. The 3-drug protocol adds one of two approved hep-C protease inhibitors (Boceprevir or Telaprevir) to the standard 2-drug regimen.

Jerome

In a message dated 1/19/2012 9:47:44 A.M. Eastern Standard Time, rubennolastname@... writes:

Larry and other interested members,Clinical trials must meet strict time-honored guidelines. They may or may not make sense WHEN you are a patient. The very eagerness to participate might confound a study since as a patient you have the added desire that trial works.Think of it this way: Even if you were selected as a patient, you are not guaranteed to get the "real" medication. The clinicians try to minimize all other factors, that way they can deal with the most basic question. Even if you are rejected in one phase of the study, there might be other phases left and they may not be so strict. Inform the researchers that you are willing to participate in later phases.Ultimately, we all benefit from these strict guidelines. Some studies allow for salvage (or expanded access) therapies if they have already passed safety standards (this is another topic altogether). If you feel you may benefit from this, make a formal request to the researcher not to the intake person (they lack the power/authority to make this decision).One last word of consolation: These guidelines do not guarantee that the drug will not be withdrawn at a later date by the FDA mostly for safety reasons.Remember there are billions at stake and big hats on the line.

..