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From Abby: Clinical Trails.

It's like a Paas egg coloring kit, no?

Abby tackles clinical trials and that feeling of "catch-22" in today's post, and this is an issue that's very top-of-mind for me.  I wrote an article about clinical trials in the latest issue of diaTribe, and I share a lot of Abby's concerns. 

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A few weeks ago, the Twitter chat #dsma topic was about clinical trials.  There is and was a lot of conflict about this topic - online and in my mind.  Last summer a few of us at Clara Barton Camp looked into participating in the Closed-Loop-System trial at MGH. It was something we fully believed in and seemed easy enough to help with. I personally couldn't do it because I was still in nursing school in NY at the time and didn't have a schedule flexible enough to spend the amount of time necessary in Boston for the trial.  I know that another staff member at camp got through the blood test portion of the trial but found out she was still making a small amount of her own insulin, and was unable to further participate.

Clinical trials are a vital step in the process to approve new technology, medication, therapies - pretty much anything - through the FDA. I fully support the trial process (it's the scientist in me), I understand why it takes so long and I'm quite comfortable waiting for the FDA to be very, VERY sure that this product or system they're approving is safe for me.  I know that every trial needs a lot of people to test on. I'm also more than willing to be that person... in certain cases.

I've been looking at trials for a few years now, on and off. Now that I'm living near a lot of the hospitals that are conducting the trials I'm looking into them more seriously and more in depth.  There are trials for everything - from using asthma inhalers to raise blood sugar, to getting a full medical history of PWD to track disease process, to taking experimental medications.  I know it's selfish, but I'm definitely not going to ingest, inject, or inhale any medication that hasn't previously been FDA approved or that could harm me or change my health in the future. I'm young, I'm healthy, and I have a lot of plans for my body in the future.  That being said I know someone has to try these new things to find what works.

It's a catch 22, I guess. They need "me", and "I" want them to cure us, but "I" am not willing to try some of their methods. The question is, I suppose, who will? I think about this a lot, and I haven't changed my mind, but it is for sure something that pulls on my moral heart-strings.

For now though, I'll stick to applying to trials that won't permanently change me or my body, and trials that I believe can make our lives better. Not just for me, but for all of you out there, and all of the people who have yet to be diagnosed. 

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Have you participated in clinical trials?  Why or why not?

Comments

We have not yet participated in a trial that requires injection, ingestion, etc. of products designed to treat/cure. But my daughter, the 14 year old diabetic, wants to. This has been a mild point of contention in the household.

I would. I'm a scientist from heart and I believe in scientific methods - that gives me confidence in the substances tested in clinical trials as well as their methodology of testing. I'm also just sooo interested in knowing what comes next in diabetes research and this is a first hand opportunity to get to know e.g. a new insulin. (I know, it sounds strange.) Also: Who will test it, if not me? Maybe I will be the one to profit from it in the future, and if it's not me, than it's another fellow diabetic.

I had not the chance yet to participate in a clinical trial, but I'm listed in a register of possible test persons by a diabetes research institute here in Germany. I have been asked last week for the second time wether I'd like to participate in a trial. Last time I couldn't attend due to some exclusion criterion; I'm curios how it goes this time.

I have participated in several clinical trials - one on the natural history of diabetes and two relating to the Artificial Pancreas Project. In all of these trials I simply used the diabetes management tools I was already using and bascially the researchers just wanted data from me.

My experience with these trials has been very positive and I think there are plenty of trials going on that don't involve trying a new drug so I encourage people to explore what's out there and what they might be eligible for.

I have participated in a clinical trail for islet cell transplantation. It was something that I had done quite a bit of reading on and felt like it was something that I believed in and wanted to try. It has been a fabulous experience. I feel so much better, both physically and emotionally. I truly believe that clinical trials can be a win/win situation. I feel as though I am both being helped for myself and for the research towards the cure.

I've participated in several clinical trials, one of which I was injected with a drug that is now on the market.

I've kindof had an "I'm invincible" mentality in the past so I wasn't concerned with what may happen by using a drug that's not on the market and the research of long term effects hasn't been done.

The other aspect is, most the drugs these days have many side affects, some I think that are almost worst than what it's treating. With that said, my mentality is, FDA approved or not, we're going to encounter side effects and reprocussions to taking drugs. Why not go for it?

I came *this close* to participating in one--it was something to do with kidneys and diabetes. In the end I just could not do it, but I think it was more because I was young (14) and somewhat uncertain rather than out of any concerns about the process.

Now, I do not think I would do one simply because my health is relatively good. I'd rather stick with relatively good than damage it more in the name of science. That said, if the trial was about certain diets to help diabetes, or something like that, I'd consider it. Especially if it was an all-chocolate diet. :-)

I have always been very conflicted about this. On one hand, I know that human subjects are needed in order to move science forward. On the other hand, I don't want to be put in harms way. I feel like diabetes is enough of a detriment to my health and I don't want to take something that ends up giving me cancer or something. I am willing to give blood to help scientists conduct diabetes-related research (I've given blood to several different T1D research projects over the years) and I'll do anything that involves testing different monitoring and insulin administration techniques. But beyond that, I just don't feel safe.

I've participated in two. One is ongoing at Dr. Faustman's lab where I get a blood draw. I believe they use my blood to test detection of bad T-cells and experiment with dosages to knock those suckers out. I'm continuing to do this.

Several(many?) years ago I took part in a trial at Joslin. They were trying to figure out effective ways to educate folks with diabetes about testing before driving.

Neither of these involved strange drugs. But I were given a chance to participate in a phase III or IV trial I probably wouldn't hesitate, time allowing. I think it's important to determine where in the testing cycle they are. By the time a drug gets to the later phases, I think there's a good deal less danger.

Yep, absolutely I was in a trial - strange, unknown drug and all. Took teplizumab, a drug designed to suppress the immuno attack. It was given by infusion.

It took a lot of time, but it also helped me honeymoon for 2 years. A "side effect" though, was how it made me angry about how research was done. I was in an office that had the highest number of participants for that drug, and they were seeing unbelievable results (a small, but real, percentage of people going off insulin, or lowering dosages by 80%). AFter Eli Lilly took over, they killed it, claiming "ineffectiveness". The entire staff was floored. The drug was incredibly effective, at least what they had seen. I think it was more "too expensive" that killed it. It made me really sad and angry - how many other possibilities have been killed due to cost?

I would do another study in a heartbeat. It was a great experience, and if there's an effective drug out there, I want it before the drug companies kill it.

My life-long best friend died at the age of 57 from taking fen-phen. That REALLY put me off taking ANY new drug. I'd rather live with the devil I know than the one I don't know. I'm immensely grateful to those who do participate in clinical trials for new drugs, but I never will. Research studies involving nothing more than blood draws are another matter, and in that case I will do what I can, and I will give money for research, but that's as far as I will go.

I've always wanted to participate in a clinical trial, I guess I'm just not sure where to start.

We haven't participated in any new drug trials, but my non-d kid gets her blood drawn every year for Trial-net. I get the security of knowing she hasn't (yet) developed the diabetes anti-bodies, and they get the data they need to see what makes her (or her brother depending on you pov) so special.

My 15-year-old daughter is in a Phase 3 clinical trial called Defend 2. I didn't hesitate about putting her in it & I'm glad I didn't. By the time a trial is Phase 3, the drug has already been through rigorous testing. For this trial, you have to be in the honeymoon phase, so you get a diagnosis & have to immediately commit to participate - while your head is still spinning. But this trial has been very positive for us & I hope it will benefit others too. We've seen a doctor monthly since diagnosis. My daughter has to check her blood 4x a day, which is a good requirement for her right now (as a teen). I do think she got the drug during her infusion (2/3 chance) & I think she is seeing the benefit of an extended honeymoon.

not a clinical trial, but last month my kid participated in a research study comparing her standard diet against a modified diet originally created to help manage high blood pressure, using a CGM. it was a positive experience for us all, but of course it differed greatly from a trial that administered 'untested' drugs.

my mom had liver and brain cancer 20 years ago and participated in a drug trial. she was happy to do so in the hopes that it might help someone down the line.

it's a complicated issue.

I feel somehow reluctant of putting my child at risk with trials. But I guess when all else is ineffective...

I'm all about volunteering my body for their crazy things that they think can help. I feel like it's not likely to seriously harm anything about me if they've already gotten to the clinical trial. I also have a friend who I am super jealous of who got a islet cell transplant and is currently making her own insulin and taking just a tiny few units of insulin today. To just be a part of anything remarkable like that would be an honor for me.

Oy, I have no idea what to think about trials. Zoe has been asked several times since diagnosis this year and I just don't know what to do. I guess the timing wasn't right for us now, but I'm open to it down the road.

Thanks for this post, Abby.

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