WHY?

[Rockerforlife]

Why do the trials have plcebos anyway...for example in the boceprevir trial ,if i recieve the peg and riba only,the plecebo, and they know im a null resopnder,why then wont they let me contiue on to 72 weeks...they know i wont clear at week 48 ...seems stupid to me and a  waste of money and time

[Rockerforlife]

i eat lots of raw veggie too

[Rockerforlife]

so i guess im a guinea pig....that is the truth of the matter

[mremeet]

A placebo group is needed to "vet" the trial and to ensure (1) the patients are being treated in accordance with the standards associated with "normal" SOC, and (2) that the patients are not being cherry picked so as to bolster the apparent performance of the drug under test. That way once the trial is over and, lets say that the placebo group had a significantly higher than normal SVR rate (say it was 60% for geno 1 for instance), it would cast doubt on the test drug's SVR results (which would presumably be higher than this) because the performance of the placebo group is so far above what is known to be achieved in the past on large numbers of people. Conversely, if the placebo SVR rate is relatively low (say 25%), then in that case it might suggest that the test drug's performance may be a bit higher than what was being measured.

In short the placebo group validates the trial results, it reveals deviations from the known norm. It will expose bias (be it intentional or accidental), experimental error, or even poor quality drugs. It's a sort of experimental pedigree that essentially certifies the validity of your findings (or not).

[FoieGras]

Marc1955 is correct. The Double-Blind Randomized Controlled Trial is medicine's Methodology for Truth. It's the only way we have of distinguishing snake oil from effective medications.

The alternatives are to get your Scientific Truth from a Guru/Wise Man/Eminent Person, or to believe advertising. Neither option serves your interests.

As I understand your question, you are asking why the study designers seem to think that SOC for nonresponders is 48wk Peg/Riba, and I agree that it's a bit odd to compare known nonresponders on a treatment they have already failed vs a new treatment.

Rock on!

[Marc1955]

It has to do with the established standards  for a double-blind experiment. If you want to prove the efficacy of a medication, you need two groups – a group that gets the medication and a control group that does not. You can't get a drug approved for treatment without such studies. This is one of the limitations of participating in scientific trials.

[Rockerforlife]

i will know if i get the real too...there are ways to tell

[Rockerforlife]

yes...but in my trial.. even if do respond ..i may be getting the riba and the peg not the real protese drugs...the placbo drugs..it still wont do me any good to do 48 weeks of SOC drugs...the SVR rates for a relapsers doing the same drug for the same length is a waste...see my point...one arm of the trial WILL be doing riba and peg fof 48 weeks in this trial...1 in 5 people

[Isobella]

Double check the guidelines for your study.  

For instance, in mine they follow SOC guidelines.  So if you are not responding, they will discontinue tx-regardless of whether you are getting the placebo or the real drug.