Effects of ending a clinical trial

I recently had a visit from the trial people for the drug I’m testing in the MADE trial. This is month 15 of a 2 year trial.
I asked what would happen at the end of the trial and was disappointed by the response. We simply stop getting the visits and stop getting the tablets. We can go to our GP and ask to take Minocycline as it is a registered medication but we wouldn’t be able to get it in the high dose that we currently take as we could potentially be taking a far higher dose than usual. Our Gp could also refuse to prescribe.
No one will monitor the impact of stopping the medication, which seems very short sighted on the part of the researchers as it could provide valuable information.
I acknowledge that we don’t know if we’re taking the placebo, 200mg or 400mg and will apparently never know, which again seems wrong. I can’t see any reason why we shouldn’t be told if we want to know.

IF the medication is proved to have worked AND we’ve been taking it – it could have drastic effects on our well being by suddenly ceasing the medication, so not to be monitored seems strange. The placebo may have had a positive affect for some people simply because they were taking something. – again, not to assess the impact of ceasing the medication seems like a missed opportunity.

I think more work needs to be done to support patients post trial as simply to abandon them seems to lead me to revert to the use of the phrase ‘Guinea pig’ which I’ve always spoken against in the past. They look after you well while you’re usefully trailing medication but then abandon you when you’re no longer useful – very sad.

No one appears to consider the effects finishing a trial may have on the participants or in fact measure this outcome. Don’t get me wrong, I’m still very much in favour of involvement in research and I’ll be looking for the next opportunity as soon as I’ve finished this one, but not everyone may be able to move onto a new trial. I think more work needs to be done on post trial support and monitoring.

I wonder if anyone out there has had any good or bad experience once they’ve finished a medication trial…..?

 

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About wendy7713

On the 31st July 2014 I was diagnosed with early onset Alzheimer’s. I may not have much of a short term memory anymore but that date is one I’ll never forget. I’m 58 years young, live happily alone in Yorkshire, have 2 daughters and I’m currently still in full time employment in the NHS. However, I’m now in the process of taking early retirement to give me a chance of enjoying life while I’m still me. I've started this blog to allow me, in the first instance, to write all my thoughts before they’re lost. If anyone chooses to follow my ramblings it will serve as a way of raising awareness on the lack of research into Alzheimer's. It will hopefully convey the helplessness of those diagnosed with dementia, as there is no cure – the end is inevitable. However, I’m also hoping I can convey that, although we've been diagnosed, people like me still have a substantial contribution to make; we still have a sense of humour; we sill have feelings. I’m hoping to show the reality of trying to cope on a day to day basis with the ever-changing environment that dementia throws at those diagnosed with the condition. What I want is not sympathy. What I want is simply to raise awareness.

7 thoughts on “Effects of ending a clinical trial

  1. Hi Wendy – just yesterday we had the JR/Healthwatch monthly dementia study group meeting that you were part of prior to your move. Charlie mentioned something similar with a drug trial he would take part in related to another health condition of his and his surprise that neither he nor his GP would know what he was taking or the outcome.

    My husband agreed to a major study a few years ago, but once we saw the protocols for the trial with only 2 treatments and no placebo, nor any attention to diet – he withdrew.

    My role in the study is looking at the connection of diet and/or medications in their role as causing and/or helping to reverse dementia. Needless to say I am coming across some very interesting information from many different sources.

    All the best
    Fiona

    Liked by 1 person

  2. Its a good question about how to end a trial in the best way, one that had not occurred to me until you raised it. It does seem like a bit of a lost opportunity not to have some follow up after the drug and / or placebo are withdrawn.

    Liked by 1 person

  3. Hi Wendy, we are also coming to the end of a clinical trial shortly. The trials unit have never known whether my husband was taking the placebo or not, as this information is screened from them and I presume only available to those undertaking the analysis of the results. It’s not clear whether the drug we’ve been trialling will make it onto the market or be available to us post-trial. We’ve been offered the option of a new trial with the trial drug and an additional drug, or to screen for a new trial with a drug which is very similar to the one my husband has been taking. It seems to make sense to stay on a trial of some description but I do worry if there will be adverse effects of my husband coming off the original drug and how these would be monitored.

    Liked by 1 person

    1. Yes, it’s the coming off the drug and subsequent effects that worry me but I’ll definitely be going on another trial – just havn’t made up my mind whether to wait a while in between yet or not. I look at it this way – we don’t know what we would have been like if we hadn’t taken the trial drug so I see anything as a bonus😊

      Like

  4. It’s a really complex area and as you say Wendy it seems like the trial participants are in many ways the least informed about the outcome, even though they were the most important stakeholders. There is a grey area where doctors do prescribe licensed drugs even if they are not licensed for the specific condition, but it is dependent on the individual doctor and of course these days the budgets of the CCG…

    Liked by 1 person

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