Being part of a study?

[Mummy76]

My neuro-ophthalmologist has asked me to participate in a study which studies the eyes to study MS.  I will be closely monitored.  The catch is that I have to stop taking any DMDs.

It's a difficult decision, has anyone else participated in a study in which they couldn't take DMDs?  Or does anyone else have any thoughts?

[Mummy76]

Thank you all for your responses.  I am going to talk to my neuro opthomologist again and let her know I don't feel comfortable participating in this study.

Thanks again for all your feedback.

[twopack]

I'm not aware that research volunteers are expected to enter studies with no expectations of personal benefit!  There is nothing wrong with the desire to gain something that would be otherwise unavailable for years.  In fact, desire for personal improvement is a natural and healthy motivation.  But it is important to balance appropriate gain against appropriate risk.  Medical research shouldn't ask you to place yourself at significantly greater risk by participating than if you chose NOT to participate.

It doesn’t seem to me that a list of general pros and cons is insufficient to test your decision here.  You haven't mentioned any treatment alternative to existing DMDs that will be offered during this study.  Was it your initial intent to forego disease modifying treatment?  If not, it seems you are being asked to risk something greater than you had already decided on - in exchange for an unspecified, and possibly non-existent, gain.  

Existing MS treatment is far from perfect.  It does, however, offer a measured record of success.  I'm not convinced this study is Mummy-worthy.  You know Mummy so please consider carefully.

[twopack]

Only you can decide if being part of this study makes sense for you.  I'd join Sarah though in encouraging you to find out more and look at this with a critical eye.

What kind of result are they looking for?  Are they trying to develop a standard for using eye health as an additional tool to diagnosis MS or measure its progression?  In that case they are "watching you closely" for disease progression that would match specific measurements of eye health.  They get their info when your MS progresses.  By then a DMD could be less effective than it would be now.  There is no turning back of the clock with MS.  Once symptoms appear you may - or may not - return to a previous state of function.

It sounds like your doctor will also be the clinical investigator for this study.  That can create a conflict.  Your doctor's primary concern is your personal health whereas a clinical investigator's primary concern is the integrity of the study.  What if there are two possible paths of action (even if both are probably OK)?  Path A would be somewhat better for you.  Path B would be better for the research study.  If your doctor is also the clinical investigator which path will he recommend?  And how will you know which role he is engaging in at a given moment?

[SarahL2491]

3 yrs without DMD protection?
not for the faint of heart by any means!

I'd seriously think that one thru before I went thru with it............

BUT I don't understand, it appears that you can be in the study either way?
with or without DMDs?

So if that's true, why even go off of them?

Just hoping I can shed some light by looking at it from outside the box

[Mummy76]

It's a 3 years study but if at any time my neurologist feels I should be back on meds, it's no problem and I'd still be able to participate in the study.

[SarahL2491]

how long would you be off of DMD ?  That might be important to you also.

I can't speak for other DMD drugs but know that rebound from Tysabri can kick your butt, don't I know!

Does sound interesting though but I'd give it some serious thought.

[essdipity]

I too agree that studies that put you at risk are not a good idea. Maybe if nothing else is working, you have nothing to lose, and so on, but otherwise, no.

I personally have never been asked to take part in a study, most likely because I'm outside the age parameters they often impose. The closest I ever got was several years ago, when my neuro told me about a new study he was planning to try. This one involved using a small amount of skin from MS patients to grow nerve cells, which presumably could be injected to replace damaged ones. He said he'd be asking me to participate, which I'd have been glad to do, though he was careful to point out that I personally wouldn't benefit.

Unfortunately that one never got off the ground, at least at Hopkins, because my neuro left to take a really big job at NINDS in DC.

ess

[PastorDan]

I'm with DV1.  If they were proposing to put you on something in place of your current treatment, maybe, but if my choice is between treatment versus none, I don't think it's a good choice.

[Mummy76]

I haven't spoken with my neurologist yet but I think she would agree to me participating.  She originally wanting me to take the wait and see approach with that DMDs anyways.

I think the pros are:
-being closely monitored
-if the study results are positive it would be a huge benefit for others suffering from MS
-no needles!

Cons are:
-possibility of a relapse if I stop taking a DMD
-big risk to take with my health and my families future

Lots to think about!

[doublevision1]

ps:  I did see your PM a while ago and still need to reply. Sorry for the delay!

[doublevision1]

Hey mummy,

I haven't participated in any studies.  Have wanted to, but impractical due to the long distance to the clinic.  All of the ones I would have considered would have had me on a DMD, or, a DMD + another med, or,  DMD plus placebo.  None would have had me on no DMD at all.  I personally would not consider going off a DMD or having only a 50/50 shot (or whatever) of, say, DMD or placebo, just for a study.  

Remember in a study, participants shouldn't enter with the expectation of personal benefit.  Those who participate are contributing to the wider body of knowledge of MS, for which we all benefit and should be grateful, so while perhaps selfish, I wouldn't want to take the risk associated with no treatment no matter how useful my contribution might be to others in the future.  

Certainly there is a benefit in the close monitoring and attention one receives as a study subject, but for me, that benefit doesn't outweigh the benefit of treatment.  The clinic you attend runs many studies; perhaps there's another that is of interest to you that would allow you to remain on treatment?

By the way, what does your neuro think?  She and your neuro-ophtha may have competing interests in terms of dealing with you as patient vs study subject.