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Avatar universal

Are the clinical trials at ClinicalTrials.gov conducted for valid medical research?

Does the National Institute of Health approve clinical trials before they are posted on their website?
12 Responses
Avatar universal
This is the trial I am consudering:

https://www.clinicaltrials.gov/ct2/show/record/NCT02657694?term=redemption&rank=1

1747881 tn?1546175878
That is nothing more than a follow up for people who have treated with generics that they got from other countries, it is not a drug trial.
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Reviewing DAA Efficacy Managing Patient Treatment In Online Neighbourhoods (REDEMPTION)
ClinicalTrials.gov Identifier:
NCT02657694
This study is enrolling participants by invitation only.

Brief Summary
REDEMPTION (Reviewing DAA Efficacy Managing Patient Treatment In Online Neighbourhoods) is observing and collating the treatment course, safety profile, and outcomes of patients around the world who are choosing to self import generic versions of the Direct Acting Antivirals Sofosbuvir, Ledipasvir and Daclatasvir from countries like China, India and Bangladesh.
568322 tn?1370165440
It's a legitimate eTrial. The results will be presented at the next AASLD.

Co
568322 tn?1370165440
Yes, any trial listed on the NIH site has to comply with their rules and they must have IRB approval. International trials like the REDEMPTION trials have even more requirements they must meet to be listed.  They must also list each national or international health organization with authority over the protocol.

Co
Avatar universal
I read the listing at clinicaltrials.gov. The trual calls for 10,000 participants. That is quite a sample.
2 Comments
They do not provide the drugs, they only collect data.

Have a great day
Also it is only in Australia.
Listed Location Countries  
Australia
568322 tn?1370165440
It says, "observing and collating the treatment course, safety profile, and outcomes of patients around the world"

and under 'Study population" it says "Worldwide"

The location lists Australia because that's where the data is collected.  

With so many people participating it will give us a clear picture of side effects.

Co
Avatar universal
Below is a description of one caring wife's successful effort to import REDEMPTION generic HCV medications into the U.S. The detained package was released after the NIH listed the trial.

I am in Michigan, I was suppose to get delivery 2 weeks ago yesterday, 1/8/16 , this was the FDA response I got ...

Thank you for the information. I fully understand your situation, a serious medical condition and expensive treatment options. But, I must address your case in accordance to applicable U.S. laws and regulations.

First, the imported medication is an unapproved foreign version of an U.S. approved medication. This foreign medication does not have an U.S. approved drug application and a valid drug listing.

Secondly, there are no availability issues with the U.S. approved medication, other than its high cost.

Lastly, the purported clinical trial, REDEMPTION-3, does not appear to be a viable clinical trial in the U.S., Europe, or Australia/New Zealand, according to the clinical trial registries.

I sent that response to Andrew at fix hep c and he wrote them stating the Redemption trials was registered and sent them the link, within hours my FedEx package was released, and no response from them stating my package was released .. lol.. so it took exactly 2 weeks..

The REDEMPTION clinical trial medications seem to have passed FDA muster
VB
Avatar universal
Thank you for posting that.
Avatar universal
I think you better re-read it.
Avatar universal
That "caring wife" is my sister in law.
Her "hubby" is my brother.
VB
568322 tn?1370165440
Their decision to let her have the meds renews my faith in the FDA.

Co
408795 tn?1324935675
Glad I saw this thread.  The Redemption 3 clinical trials are the real deal.  Dr. James Freeman helps patients all over the world and you don't have to pay anywhere near that ridiculous price big pharma is asking for.  

http://www.eurekalert.org/pub_releases/2016-04/eaft-lgd040816.php

Gil's Tire: "Well certainly sir, I can get your tire fixed in twelve minutes ... just go ahead and write me a check for twenty thousand dollars."

Fly Guy: "$20,000! That's insane!"

Gil: "No sir .... it's the middle of the night. Go ahead and try, none of the other repair guys will even answer their phone this late."

Fly: "It's just a tire!"

Gil: "Oh no sir, you've already explained to me that if this tire doesn't get fixed quickly you'll miss your flight. And you've said that if you miss that flight you'll miss your contract signing and you won't make the sale. You'll personally be out $25,000. That being the case I think it's entirely reasonable that I charge you $20,000 for the service. After all, I'm saving you $5000."

Fly: "It's just a tire, you do this all the time and $20,000 is a totally unreasonable amount of money."

Gil: "I think we are focusing a lot on price and what I didn't hear at all was the value that you're getting through the way I'm enabling you to save your deal. Now you can make out the check and we'll get this done ... write it to me personally .... My name is Gilead."

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