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information about clinical trials and phases

http://www.hcvadvocate.org/hepatitis/hepC/HCVDrugs.html

There are many compounds being studied to treat hepatitis C.  A number of compounds for these targets are in early “test-tube” development or pre-clinical “animal” development phases. Most of these compounds, however, will never make it to trials in humans (clinical studies). In fact, only one in 1,000 compounds makes it to human testing. Of those drugs that make it to human testing only 1 in 5 will receive FDA marketing approval. Therefore, every effort has been made to focus this list only on treatments that are known to be in current or very near to active clinical development in human subjects.

When a company is ready to proceed to clinical trials, it files an Investigational New Drug Application (IND) with the Food and Drug Administration (FDA). Most clinical trials are designated as phases I, II, or III, and sometimes IV based on the type of questions that the study is seeking to answer.



Study Phases

In Phase I clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase II clinical trials, the study drug or treatment is given to a larger group of people (100-300) to evaluate safety, optimal dose, and may include some information on the drug’s effectiveness.  Most drugs that enter phase II studies do not progress on to phase III studies.  This is because the drug is being tested in more people for a generally longer period of time so lack of effectiveness and a better picture of the effectiveness emerges.
In Phase III studies, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase IV studies, the drug is already on the market for a particular indication, but is now being tested to answer questions about sub-populations of the same condition it is approved to treat, or for a different indication, use, or disease.
The testing of new drugs is a long process that typically takes about 12 years from pre-clinical testing to FDA approval and marketing to the general public.



Fast Track Status:

A drug can be granted fast track status by the Food and Drug Administration to help facilitate the development and to expedite the review process of new drugs that have the potential to address an unmet medical need for serious or life-threatening conditions such as hepatitis C.



Orphan Drug Status:

A status given to a certain drug by the Food and Drug Administration to encourage the development of drugs that are necessary, but are too expensive or unprofitable to develop under regular circumstances.  Drugs being developed to treat orphan diseases (low prevalence in the population) offer tax reductions and marketing exclusivity for the drug manufacturer (up to 20 years).


6 Responses
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789911 tn?1368636783
Thanks for posting that.  I was asked to be in a phase II trial for telaprevir and VX222.  I almost did it but because of the info I received via this forum and personal research,I decided it wasn't for me.  My previous thread concerning that trial is under   ' was asked to participate in a clinical trial', not too far back.   People need to understand fully what they are getting involved with when asked to do a trial or try to get into a trial.  
Helpful - 0
Avatar universal
I completely agree. There are many things to think about before jumping into a trial. There is a downside to every trial and if the reward doesn't outweigh the risk why do it. If a person can afford to wait for these new drugs when they are on the market, and they have the insurance or means to pay for it, why relinquish the any control or input you have over your treatment to participate in a trial.

Don't get me wrong, many of us have treated successfully thanks to some of these trials. I am in a trial myself currently, but the drug has a track record and is close to being submitted to the fda for approval. My disease was progressing, and I thought it was my best shot at svr. A doctor treating through a trial does not have the same leeway to make decisions as they do when they are treating you privately.

I thought you made a wise decision to bow out of the trial you were thinking of personally.

Good luck,

Dave

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Avatar universal
From Spectda"s post it certainly is evident that these drugs in the beginning of trials are a longshot( I had read the article prior to commiting to a study that I am currently in) Yes people absolutely " need to understand what they are getting involved with"  I do understand what I am getting involved with to the best of my ability, wich  is a gamble however my feeling is sometimes you just have to take a shot.
Helpful - 0
179856 tn?1333547362
Dave this is a great thread and sure should help people thinking about participating to evaluate thoroughly the risk vs. rewards.

Granted, some folks have vast damage and no insurance and need to do trials but even this group needs to pick the right one and not just jump on any train that comes along thinking it will be successful because the company says so.
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179856 tn?1333547362
Dang I hit send before I meant to - His I think you made a good, well informed decision and that is all you can do in the long run.

The first thing you did right was joining our group  ;)
Helpful - 0
Avatar universal
Always so good to see the potential future drugs!!  Here's a link to a graph for the new drugs which might not be as up-to-date but it's interesting and lays it out visually.

http://www.hcvdrugs.com/
Helpful - 0
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