Skipping trials

[xman]

Did it ever happen that a trial phase was skipped to archieve immediate approval for a new drug? What I mean is let's say a drug looks so promising and functional in early phases that it has a 98% of effectiveness does exist any other approach than fast tracking? Must a drug necessarily pass all the 3 phases of clinical testing?

[Inchlingblue]

The FDA has three different categories for considering drugs faster than normal:

Fast Track
Accelerated Approval
Priority Review

The links below explain them. I've never heard of a situation such as you are describing, which would be faster than Fast Track. During Phase I it would not even be possible to know effectiveness since that isn't considered yet so I guess the earliest they can have an idea on this would be Phase II.

I'm curious about other countries in this regard. Aren't there drugs available elsewhere that are not yet FDA approved? Do other countries, especially developed and rich countries, have a similar approval process as the FDA?

LINKS:

http://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/SpeedingAccesstoImportantNewTherapies/ucm128291.htm

http://www.drugs.com/fda-approval-process.html

[veritas]

Inch,

There is another way! It's called the "Animal Rule". Used mainly to find a therapy for diseases that cannot be tested safely in humans (ie: ebola, bio-terrorism etc.) That's where broad-spectrum anti-virals come into play. Basically, the therapy is tested in animals for safety and efficacy and safety in humans. If found to be effective against the pathogen in animals and found to be safe in humans, the drug can be approved for use without going through the three phases of drug development.
This is a very new concept. It's not more than three years old I believe. It was developed due to the DOD's program for a  Bio-terrorism Threat.

http://www.bcg-usa.com/regulatory/docs/2003/WSP20031023C.pdf

v

[Inchlingblue]

It sounds interesting but would it apply to HIV?

They specifically say it's for: Drugs & biologicals that reduce or prevent serious or life threatening conditions caused by exposure to lethal or permanently disabling toxic biological, chemical, radiological, or nuclear substances.

And: Rule does not apply if product approval can be based on standards described elsewhere in FDA's regulations.

It's hard to tell based on the above parameters if anti-HIV meds or vaccines would qualify? Maybe broad spectrum antivirals tested for something else can also work against HIV.

 

[veritas]

Inch,

Your right, they would not include HIV drugs per se. However, what if one of those broad- spectrum anti-virals just happen to work against HIV also ?? Think of the possibilities!!!!!!

v

[Inchlingblue]

I can see it, sure. There are several promising broad spectrum antivirals (anti-ps, etc).

[veritas]

  BINGO !!!!!

[mecch]

I don't know about skipping trials.
I personally benefit from Intelence, which went through on the fast track.
My ID was reluctant to give it to me, for that reason - not tried and tested and completely known.

Its a great and happy chance for me.  It was approved last year, and I converted last summer, and two established combos gave me side effects and Intelence seems to be the one for me. How lucky is that. Thank god I didn't have to suffer years of Sustiva, which worked on the virus but drove me nuts.

[veritas]

mecch,

I understand your ID's  reluctance. One never knows for sure how a medication will react in one's body,since all meds are personal. But for me , I would take a shot at a therapeutic if it proved to eradicate the virus in animals and showed safety in humans. Take an antibody like anti-ps (Bavituximab),it has been tested in over 200 patients so far with various indications and has shown top-line safety data .  Even if it couldn't eradicate the virus, but could provide a functional cure, it would be a godsend.
Just another thing to think about for those of us living with this disease.

v

[Inchlingblue]

I was reading about Dr. Yong Kang's therapuetic HIV vaccine, which will likely start Phase I trials in the next few months, and the article stated:

Kang’s vaccine is currently being manufactured in a Maryland laboratory in anticipation of FDA approval to continue with Phase 1 and 2 human clinical trials. His vaccine could be available for therapeutic use within three years and for use as a preventive vaccine within the next six years.

I wonder why they give such a timeline, considering normal FDA procedures? Obviously they could be mistaken, but the source of the article seems like a legitimate one.

LINK

http://www.chrcrm.org/main/modules/pageworks/index.php?page=002&id=565

Another article, a Press Release, says this:

If the vaccine is given the go-ahead to enter into human clinical trials, it will be at least four years before Kang expects to have statistically significant analysis, and possibly allow the vaccine to be marketed.

LINK:

http://pharmalicensing.com/public/press/view/1247503351_4a5b63f78d0ba/

[veritas]

Inch,

Some history on Kang's vaccine (scroll down).

http://www.canada.com/nationalpost/news/story.html?id=8b7d5164-05f6-4333-8e9d-c9d5bd9154a4&k=31733

The article states that it would not take as much time to test the therapeutic component of the vaccine vs the preventative component, which of course makes sense. However, as far as the timeline is concerned, perhaps they are counting on accelerated approval and /or priority review. As a therapeutic, I imagine it would not take too long to determine it's efficacy but the safety would be somewhat suspect unless they found no AEs in all volunteers given the vaccine. Let'hope he has it !!!

v

[xman]

veritas,

the article you posted is from 2006. three years wasted. fda is still sleeping. can't understand what they are waiting for. i hope they will begin soon with these trials and that we will not read the same in 2012.

both articles from inch and veritas are quite identical but one published in 2006 and the other in 2009. what happened in this time? additional animal testings?

[Inchlingblue]

both articles from inch and veritas are quite identical but one published in 2006 and the other in 2009. what happened in this time? additional animal testings?

It's true but it looks like at this point they are finally going to start Phase I very shortly (one article says October 2009).

The 2006 article says Phase I could start in one year so that makes them about 2 years behind schedule. It's best to give them the benefit of the doubt and assume that during that time they were perfecting it and leaving no room for error.

I'd hate to think that during those two years Dr. Yong Kang was either picking his nose or jacking off instead.

xman, you gotta have faith. Remember the George Michael song?

[georgep77]

I'd hate to think that during those two years Dr. Yong Kang was either picking his nose or jacking off instead.

xman, you gotta have faith. Remember the George Michael song?

Lol..... maybe the favorite song of xman is careless whisper   

[dadx4]

I have seen "Fast Track" by the FDA.  I have also seen where drugs have been approved based on Phase II studies.   Phase I is usually mandatory for safety, phase II is for efficacy but a small population versus placebo.