Clinical Study?

[susanep]

I received an email about a clinical study being put together in an area about 1 and half hours away from where I live. I sent a email back that I would like more info about it.

Since then they have called me twice trying to get me to come and sign up for it. I am willing to help out, but have too many things going on.

My husband would be driving me there, for multiple trips, and traveling is hard on both of us. Also we have only one car at this time.

I went back to find some more info on it, and after a person signs up, they are in it for maybe life. It just scares me a bit. I told them today, I didn't want to take anything to make me worse.

They said, well we can have the Dr. call you right back to address your concerns. They are very persistent, but I know that is the only way they can study this. Well, there main things is Lupus, and then address the other overlaps also.

What do you folks think? I welcome all your thoughts.

susanep 

[A66eyroad]

I'm very visual, and to make a big decision I've always had to write things out.

Usually I fold a piece of paper in half and list the pro's and con's. Recently I've started assigning "weights" to different items in the list, for example time has more weight than, say, cost. Or vice versa.

I've never been a "big picture" person before Sjogren's, but I've found that I've become one out of necessity.

I'll sit back and read what others have to say.

[susanep]

Thanks A66eyroad, Yes I don't really trust my own judgment these days on most decisions.  I am not clicking anything again out of curiosity of more info though on anything really serious.

susanep 

[quietdynamics]

Curious....how did they get your email???

[susanep]

I had clicked on something about the trial I had seen, and entered it to see if they would just send me some more info.

Sorry, I went back to look at what I said, and it did sound like they first emailed me out of nowhere. I didn't mean for it to come out that way.

Lately, I have been having mental issues like this more often. Hopefully it's my neurontin, because I have had some things like that and swaying when I walk that I didn't have before in this way.

susanep 

[warmwaters]

I found it hard to tell what the details are from your post, so forgive me if I get too detailed.

There's a couple of ways to look at it -

Will your participation help others?
Will your participation possibly help you?

There's a number of ways that a study can be structured.

One is that they are gather data about people - for example - you have Sjogren's, and you take medicine XXXX - let's track your levels of (some factor) over a couple of years and see what happens.  That's a pretty safe study, other than the time and inconvenience to you. So you give, and some of us may benefit, but it really doesn't change your health situation.

Another is a study type is where a treatment is tried - you may get the treatment, and you may not. Sometimes you don't know if you are getting the  treatment or not, which helps to ensure that there's no placebo effect, where people think they are doing better because they are getting the cool new treatment.  In this scenario, you may get a treatment that helps you, or you may get nothing, or you may get the new treatment, but you have yucky side effects. If it's this kind of study, you really need to find out what you might be getting into, and whether you are willing to take a risk.

Never an easy call, but please tell us more, and we'll all happily chime in with our opinions!

[soycoffee]

I found it hard to tell what the details are from your post, so forgive me if I get too detailed.

There's a couple of ways to look at it -

Will your participation help others?
Will your participation possibly help you?

There's a number of ways that a study can be structured.

One is that they are gather data about people - for example - you have Sjogren's, and you take medicine XXXX - let's track your levels of (some factor) over a couple of years and see what happens.  That's a pretty safe study, other than the time and inconvenience to you. So you give, and some of us may benefit, but it really doesn't change your health situation.

Another is a study type is where a treatment is tried - you may get the treatment, and you may not. Sometimes you don't know if you are getting the  treatment or not, which helps to ensure that there's no placebo effect, where people think they are doing better because they are getting the cool new treatment.  In this scenario, you may get a treatment that helps you, or you may get nothing, or you may get the new treatment, but you have yucky side effects. If it's this kind of study, you really need to find out what you might be getting into, and whether you are willing to take a risk.

Never an easy call, but please tell us more, and we'll all happily chime in with our opinions!

More information on the "cool new treatment" kind of study. That's about how the pill study my neat eye doctor (all five of them are neat!) described the study she is running, on a pill that is already proven to reduce mouth dryness. It's a long study, and I cannot take Plaquenil during it, but I can take Prednisone.

The important thing is that there are two rounds of treatment. During one of the rounds I will get a placebo, and during one of the rounds I will get the investigational drug. Neither I nor the doctor/technician/whoever will know which bottle of pills I'm going home with. So I *do* get treatment for part of the study. I'm hoping placebo effect helps with the other part -- and the interest of the experiments, and all that.

AFTER the study is completed, I will have the option of receiving (probably free, for a while) a course of the drug that was investigated -- perhaps at a different dose.

So, it's worth it on the chance that I can take a daily pill or two that will be faster and simpler than the eye care routines I'm building now!

It's called a double-blind, placebo-controlled study, and is the best experimental model for clinical trials of new drugs.

On the criteria
Will my study help other? Yes (particularly if this drug pans out for dry eye as well as dry mouth)
Will my study / clinical trial help me? Yes, as long as the investigation drug works as expected, it will. I will get one round of it during the study, and another round afterwards.

There's a similar kind of study where one doesn't know whether s/he is in the real drug or the placebo arm, and there's no crossover. Still, if I were in the arm that got the placebo, then after the study was I would get the investigational drug (or treatment).

So it really depends on the things being investigated. And, of course, the potential for "yucky side effects." OH, and the lifestyle or medication changes that the study requires, like not starting Plaquenil until it's over.

Soycoffee

[soycoffee]

Oh, the third kind of study, another one I'm enrolled in, is a diagnostic study of Sjögren's Syndrome. I gather that what happens is I go in one morning at 8 am (ugh!) and get many different tests that have been said to be linked to Sjögren's Syndrome as diagnostic indicators, or potential diagnostic indicators.

This is of benefit to me, because I get ALL these tests run, whether my current doctors think there's any reason for the test.

It is of benefit for others, because although we study participants get lip biopsies (done at a professional treatment center for Sjögrens, and presumably done well) the study should be able to develop a prediction equation from the cheaper, and less intrusive procedures, in order to avoid the more difficult, more painful, more badly done, procedures (I hope). Or at least the study will be able to demonstrate that lip biopsies really have to be set as the gold standard, and doctors will have to be taught to do them or refer them to other doctors who can do them.

So far I haven't heard of a study like the first one mentioned above, where a drug is followed for a lengthy period to develop information on its clinical characteristics.


Soycoffee

[Joe S.]

If they ask you to pay money for treatments or anything Run away. If you can find out who is doing the study check them out online. I am really skeptical on most of this type of study. My BIL works for the Human Nutrition Lab (a government agency) and does studies day in and day out.

[lolo1979]

susanep - much the same as the others have already said - I would find out whether a trial medication will be used, and if they know what the possible side effects are.  Is it something that can cause other damage for you?  If so, you have to weigh the risks.  On the flip side, if it is a medication that could potentially help you a great deal, then it may be well worth entering the trial.  I would also find out what happens if you cannot continue the study.

If it is a study just to study you over the long term - I would personally skip that.  In that case, there's not much that can be gained from a benefits versus time ratio.  Driving 1.5 hours multiple times just for them to determine your eyes are inflamed or your SED rate is high or whatever else just doesn't seem worth it.  Only my opinion, but I'm tired of those types of studies as it relates to sjogrens.  We already know the risk factors, what is happening to us over time, and so on.  For instance, I saw a news story yesterday about a study done that determined having an autoimmune disease quadruples our risk of pulmonary embolism.  Well DUH!  Having an AI disease puts us at increased risk for all kinds of ailments.  We KNOW the problems! We need doctors studying TREATMENTS! 

Just my two cents!  Good luck with your decision!

[lolo1979]

PS - Soycoffee - are you saying that you are participating in a study for a drug for our mouth?  I'm intrigued!!!  Is it a drug that is supposed to help stop the damage to the salivary glands? Or is it something similar to evoxac?

[soycoffee]

Joe, These studies are being conducted by the Sjögren's Syndrome Center/Dry Eye Center at one of USNews and World Report's Top Ten Hospitals nationally. They are paying *me* not asking me to pay. One kind of study I outlined, that they are conducting, is the gold standard of determining the efficacy of a particular treatment.

lolo1979, I'm not working for the dry eye *pill* study, just volunteering as a study participant. One of the things that researchers do (since I have worked that side of the fence as investigator and as statistician) is control the information participants have. If I knew too much about the drug, then, since it is already being used for dry mouth, I would try to figure out what it is, and anticipate the reactions I might have, and mess up the study.

The second study is to provide evidence that an existing treatment for skin rosacea can be extended to ocular rosacea (an additional source for dry eye, which I have). It will either work or not work. I can see the bumps of ocular rosacea on my eyelids, and my eyes are definitely dry. The study is based on observations that when this treatment is used on facial rosacea, it also has cleared up dry eye due to ocular rosacea. They just need confirming evidence, hence the study. It may clear my facial skin, too, as a bonus. It may not. It may not clear up the ocular rosacea, either, but I'm ahead of the game by knowing I have ocular rosacea and how to treat it!

The third study is really one of those "too many of these" studies, that make a name for the researchers and the place where the research is done. They will come up with the "(Hospital Name) Criteria for Diagnosing Sjögrens." It's a way for me of getting free tests, and expressing appreciation that there is an SjS diagnostic and treatment center so near.

The one study that might be worth driving an hour or so to get to would be the first one I mentioned. It lasts between 26 and 30 weeks, and there are 9 visits to the hospital grounds. The study pays $440 if a person completes the study in  either $50 or $35 gift cards at each of the nine visits.

If the pill proves to be helpful not just for dry mouth, but also for dry eye, think of the saved time and hassle -- and even possibly money for OTC products. But it could not work out, statistically, or in terms of side effects, or whatever. We don't know.

Oh, and the woman ophthalmologist who recruited me is tops at diagnosis and concern for the pt as well.

Thanks for your questions and concerns,
Soycoffee


Oh, and the place where the three  studies will be conducted is /used to be within walking distance of my home, in good weather.

[Joe S.]

Thank you soycoffee. I did not want to hear you were being taken advantage of. I ran into one that was a scam. When the asked for my insurance so they could bill I backed away.

[warmwaters]

I once participated in a study on ultrasound during pregnancy done back in the late 80s. They were looking at whether in a routine, normal-risk pregnancy there were any medical benefits to the baby  to doing ultrasounds.  Obviously not a blind study, as it is hard to "fake" an ultrasound. 

The results were that it made no difference. Amusingly, that did not become common practice, because everyone wants to see the baby, and possibly find out the gender.

[soycoffee]

Thank you soycoffee. I did not want to hear you were being taken advantage of. I ran into one that was a scam. When the asked for my insurance so they could bill I backed away.

Thanks, Joe
I figured it might be something like that.
Take care,
Soycoffee