How Many of You Would Consider Being in a Trial?

**Katie** · 10-25-2009, 11:50 AM

Kathy, I know that you are/were in one at the TBI, and I assume that you were happy with the results.

But how many others would be comfortable with letting a doctor test their product on you? Or being in a blind trial where you don't even know what device you were given for quite awhile?

I am looking into the various trials around the world, trying to find something, anything that can be used on me, after discovering that I was allergic to all of the appliances I was going to have implanted last week.

I need to find something that is inert like plastic, or one that is made of pure titanium. But the thought of being someone's guinea pig sort of sends a shiver down my back.

I keep thinking of Murphy's Law and how I would get the wrong one inserted, the one that I'd be allergic to

Not many have this issue though, and maybe don't care which one they get as long as they are out of pain.

Would you willingly be in a trial? And under what conditions?

**ajj1001** · 10-25-2009, 01:34 PM

Thought long and hard about this one and there are certain risks I would be unhappy to take. Whatever my quality of life is like at the moment, the risk of it getting any worse would be unacceptable. If it was a case of two completely acceptable alternatives then I would happily go with a trial not sure about anything involving an inferior choice.

Nor sure if you have seen this (Lynda recently post up on adr uk) -

CryoLife : BioDisc® Nucleus Pulposus Replacement

**KBear** · 10-25-2009, 04:37 PM

Katie, The reasons that I felt the trial was acceptable were:

1) The control was Pro-Disc, the exact same disc my doctor wanted to do ADR on me with.

2) The 'experimental' disc was the Active-L, which has been used in Germany for a few years, and was in the final stage of trials in the US.

3) By being in the final stage of trials, that means it has already been through exstensive testing and is at the last stage before FDA approval. Had the device not been safe, earlier trials would have shown so and the trials would have been stopped.

4) I was one of the last hundred patients to receive the device in the trials. The two year data was coming in and was very positive.

5) This device was also already approved and on the market in Germany. Ruth also has the Active-L, not sure where she had surgery; but I know she is in the UK.

6) My dr in Texas told me that he felt the Active-L is the best device out there, due to the hybrid model of constrained/un-constrained design. He also said that when this device is FDA approved that it will be the choice ADR and replace the Pro-Disc in popularity.

7) The dr who did the surgery is the co-inventor of the Active-L. He is also known world wide and has exstensive ADR surgical experience.

8) I felt that even more care and precaution would be taken through a
trial versus just having surgery. The doctors who do these surgeries are usually financially invested in these devices, thus have a big incentive to make sure the trials go well and thus make it to market, where they will profit. Since they do want you to have a positive result, they are probably going to take more care and pay very close attention to detail during surgery. You also go through a vigorous screening and have to meet clinical criteria to be in the trial.

I would definitely not rule out a trial; but would evaluate each trial seperately and decide that way. There are definitely trials that I would not be in, due to them being in early stage testing and thus not proven.

My trial was a double blind trial, meaning that neither the doctor or I knew
which device I would get. The night before the trial, the researcher calls and independent company, gives my patient number and they tell them which device I will get. The doctor finds out on surgery morning what I would be getting. I was not supposed to find out for two years; but when you see the x-rays of your spine with the device in it, it is very easy to tell what device you received. I easily guessed the Active-L and the dr confirmed that I was right. That just can't come out and tell you; but you can figure it out. I really didn't care either way, I just wanted surgery and either device would have pleased me.

**dalhousie** · 10-25-2009, 05:44 PM

Katie - I had surgery in the UK with the activ L but not in a trial. The surgeon I had (Mr Shackleford) operates on a significant majority of the membership on the ADR UK site. He was recommended by my previous surgeon as well as the ADR UK site. Mr Shackleford said he thought the Charite wasn't a good disc when it first came out. Prior to the active L he used Prodisc & he said that the activ L was the best implant he'd come across so far. Along with his opinion & the information I had gathered over the net on the activ implant I thought it the best choice at the time.

I would agree with what Kathy has said & take each trial/implant at face value with a surgeon you are comfortable with.

**KBear** · 10-25-2009, 05:49 PM

Originally Posted by Ruth

Katie - I had surgery in the UK with the activ L but not in a trial. The surgeon I had (Mr Shackleford) operates on a significant majority of the membership on the ADR UK site. He was recommended by my previous surgeon as well as the ADR UK site. Mr Shackleford said he thought the Charite wasn't a good disc when it first came out. Prior to the active L he used Prodisc & he said that the activ L was the best implant he'd come across so far. Along with his opinion & the information I had gathered over the net on the activ implant I thought it the best choice at the time.

I would agree with what Kathy has said & take each trial/implant at face value with a surgeon you are comfortable with.

The bolded above is exactly what my surgeon in Texas, who did not do my surgery said, as well as the surgeon who did the surgery.

Before being denied by my insurance, and going through back pain, I would have never had been in a trial. I evaluated the trial based on what it had to offer and if it fit my needs. There are tons of trials out there, and if you don't like any of them, there will be more to come. Go to clinicaltrials.gov and search the trials and see if you can find something you like. I would then pick my 'favorites' and start doing the research. Good Luck.

**Katie** · 10-25-2009, 08:37 PM

Thanks everyone. It sounds very encouraging, especially that more and better appliances are coming on the market. I just don't know how hard I should be pushing, with all the 'what-if's' out there. The hard, solid surgeries are iffy enough, let along a 'trial' version.

But put that against sitting back and doing nothing and it doesn't seem so bad.

**Cindylou** · 10-26-2009, 07:29 AM

Well, I had responded to this the other day Katie, and now I see it is not here. Weird. So I will respond again. My perspective was: certainly my age is a huge consideration, and I presume it would be a deciding factor from the trial's perspective too. Maybe I wouldn't even qualify based on age cutoffs. So that would be one of the first things to find out. Secondly, I used to think I would never consider a trial. That has changed. Now, if I was desperately in pain, I would be open to any and all possibilities. Doing nothing still adds up to nothing. Doing something could just possibly alleviate or significantly diminish my pain. My best to you honey, as you wade through all the "what ifs."

**Justin** · 10-26-2009, 09:59 AM

Personally, I would be part of a Clinical Trial. However, I would have to extensively research the trial and the proposed intervention (that's the short and sweet of it

).

With that said, there are many trials (drugs, devices, etc.) that I would not participate in. Clinical trials are highly regulated and they have very strict inclusion / exclusion criteria.

Here's some general information regarding Clinical Trials from the U.S. National Library of Medicine:

Phase I: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

PHASE I TRIALS: Initial studies to determine the metabolism and pharmacologic actions of drugs in humans, the side effects associated with increasing doses, and to gain early evidence of effectiveness; may include healthy participants and/or patients.
Phase II: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
PHASE II TRIALS: Controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in patients with the disease or condition under study and to determine the common short-term side effects and risks.
Phase III: The drug or treatment is given to large groups of people 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.

PHASE III TRIALS: Expanded controlled and uncontrolled trials after preliminary evidence suggesting effectiveness of the drug has been obtained, and are intended to gather additional information to evaluate the overall benefit-risk relationship of the drug and provide and adequate basis for physician labeling.
Phase IV: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

PHASE IV TRIALS: Post-marketing studies to delineate additional information including the drug's risks, benefits, and optimal use.

This is a great resource that answers all of the Frequently Asked Questions about Clinical Trials: Understanding Clinical Trials from the US National Institutes of Health.

**linda** · 10-26-2009, 09:32 PM

Hey Katie,
I also responded to this the other day but it was lost. I got reenrolled into the Axiomed trial last Tues. but still so uncertain of the uncertain...
Doc said I could have an 80% chance of pain relief where I thought I read somewhere it was 65%. He still keeps being given the Prodisc and hasn't put one of the Freedom discs in yet which kind of scares me. These two discs are totally different also. I got to see the Prodisc this time and it moves a lot whereas the Freedom disc is all one unit. I just don't know what to do Katie. I'm tired of thinking about it all the time everyday.
Linda

**Katie** · 10-27-2009, 11:11 AM

Linda, I'm so sorry. This is the sort of thing I'd be worried about...wanting to be in the side of the trial that gave me what I thought was the appropriate disc for me, and ending up with the opposite one.

How do the trial doctors decide which disc goes to which patient? Do they take the physical needs into consideration, or do they just go by numbers....so many patients have to have X disc, and so many get Y, just to fill requirements?

The few surgeons here in Canada who do ADR surgery have a choice of just about every disc out there. We don't have the FDA restrictions that are in the US. I had discussed the pros and cons of each one that my surgeon used and we had decided on the Maverick. But it was for very specific reasons. Do the trials take this into consideration at all, or just put them in, 'just because'?