Questions about clinical trials

[Carson]

Trials surely can be complex and curious endeavors from a distance for those of us with no training or formative medical knowledge. I've even heard hypnosis is part of some pre-trial testing. I have many questions about trials but primarily interested in the length of trials and how many are currently active today. If you'll bear with me here:

• Is the Active L trial done?
• Is the Freedom trial done?
• Does every disc that makes it to market undergo human trials?
• Also, how long do trails typically last or is that entirely up to the disc company and/or FDA?
• Lastly, can we compile a list of all current trials for both cervical and lumbar?

Thanks for any help

Carson

[linda]

ey Carson,
I just timed out of the Freedom Disc trial. You have to reenroll every 6 months here. I asked my doc when it would be over and he said around the middle of this year. A few weeks ago I called the study girl to get a surgical date as I thought I had my nerve up to do it plus I am sick of the pain. She said they were booked until July and were only doing one per month. This could be different everywhere because my doc seems to go out of town a lot - sometimes for a month. The Freedom trial is for only one level. Anyway that is all I know for now. I need to just do it and get it over with. In a way I've kind of waited to see how everybody on the site comes through.
Good Luck and Take Care,
Linda

[KBear]

The trial I am in, Active L, is a 2 year trial (2 years per participant). It lasts longer than that, b/c they have to enroll x amount of patients and then follow each of them for 2 years. So, if the first patient is operated on 1/1/08 and the last on 7/31/09, then the 2 year period, with the 2 month grace for appointment, would not have the final patient data until 9/30/11. Then they have to compile, study and write up (whatever else they do) the data. Then, the FDA reviews it and decides whether it goes to market or not (I am sure I am making this way more simple than it really is). They also do like pre-trial trials, where a smaller number of people are enrolled and operated on, if this is decided to be safe, then the big trial opens.
On the Active L, I was told, probably 9 months ago, that they had just enrolled their last patient (now they may have been just referring to their location, or the trial as a whole, not sure). How long enrollment is open really depends on how many people sign up, how quickly, and when they are operated on. Their are multiple sites for each surgery, I want to say the active L had like 10 or more sites and each site has to do x amount of surgeries. I live in Tx and go to Texas Back Institute, who did participate in the Active L trial. They are a large office, with many surgeons and many patients. They quickly completed all the surgeries they could do. Whereas, where I had surgery, in Miami, FL, with the co-creator of the disc, he remained open for almost a year after them, because he was a lone surgeon in the practice doing the trial. So, it is all variable.
Here is a link where you can look up all clinical trials going on currently. It also lists the sites, if they are completed, enrolling, about to enroll, where they are (some don't even get done in the US, or at least the early parts aren't done here), etc. www.clinicaltrials.gov

Hope this helps,
Kathy

[Carson]

Thanks Linda and Kathy.
So a trial ends when the last patient in the trial to receive a disc completes their trial, eg, 2 years for the Active L. Thanks that makes better sense.

So, as much as we've heard about the Active L and Freedom to this point neither of them is technically "on the market"; I believe I have that much correct. I assume the spinalkinetics M6 cervical trial is, at a minimum, done accepting applicants based on this quote from the company: "The completion of patient enrollment for our M6-C U.S. Feasibility Trial is a major milestone for our organization and we look forward to the follow up results of these thirty patients,". I've never heard the term "feasibility trial", however. Is 30 a low or high number of trial participants on average?

Thanks greatly for the trial link, KBear. Precisely what I was hoping to find! I owe you at least 12 high 5s for different times when something you've mentioned/posted, sometimes even just in passing, has helped me avoid confusion and/or redirected and made one of my searches for an answer more efficient. Thanks to everyone here for all the help.

[KBear]

Carson,
On the discs being on the market, yes and no. They are not on the US market; but they are available in Germany and many other countries. So, there are people on here who have the same disc as me, yet paid for it in Germany, whereas I got mine free through a trial. This is why I really didn't feel like a 'guinea pig' being in a trial. Because many of these products have already went through other countries equivalent of the FDA and are being used there.... so it wasn't like I was the first. I also signed into the trial when it was 18 months into it, so they were already getting back 1 year data on patients.
On the M6 disc, that definitely sounds like they are done enrolling. However, 30 sounds like a very, very small number of patients. It is my understanding, that there are several stages to a trial, in the first stages they enroll a small number of patients, do the data and then have to get the go ahead from the FDA to go to the stage of large patient enrollment. Hence why other countries get stuff to market sooner than us, it takes years for these trials from start to finish.
Oh, and your welcome, that's what we are here for.... I was soooo lost when I started researching ADR, I didn't think I would ever get it, but with encouragement from other members (CL, Terry, Justin and many others), I finally got it!

[Carson]

Thank you. So, in fact, those discs are on the market in some countries but still awaiting approval from the FDA here in the US. That's making better sense, thanks. I've always wondered why it takes longer in the US than in other countries so that would clearly be a part of the delay, as you mention, our having more stages to trials here.

From a distance, based on reading around the forums and in general, it seems there are fewer patients leaving the country for ADR than a few years ago. I would guess as we move forward and FDA permits more discs fewer and fewer will need to travel for surgery. Then again, as new devices are created, other countries will seemingly have them available ahead of us so perhaps there will always be a percentage of folks who travel for spine related procedures. Would be an interesting study. Thanks again for the info!