Ship of Fools: Clinical trial - what do you think?

Thread: Clinical trial - what do you think? Board: Oblivion / Ship of Fools.

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Posted by Boogie (# 13538) on :

I have moderately serious psoriasis and have the opportunity to take part in a clinical trial for a new drug.

I realise that medical advice can't be given here but, other than that, what would you do?

The trial is five years long, involves very extensive initial testing of every bit of the body, internal and external. Then fortnightly injections which I would administer myself.

I could withdraw at any time of course if side effects etc occurred. It is a very large, worldwide trial.

Any thoughts/experiences etc?

Posted by no prophet (# 15560) on :

Find out who is sponsoring it - drug company, gov't funding agency. But it should be provided in the sign up and screening for subjects/participants.

Find out who are the principal researchers. Better if a number from several institutions.

Find out if you'll be offered the actual drug if you're in the control group. Sometimes they have a series of stepped controls, where group a gets the drug now, group B later etc. They may not tell you.

Find out side effects and care in the situation that there are any.

Ask you doctor and specialist if any.

My tendency is to generally go into such a study if your symptoms are bad enough to warrant it.

Posted by Adeodatus (# 4992) on :

Be clear about the terms of the trial. Very few trials these days are "drug versus placebo", because of the ethical problems of not treating (or treating only with a placebo) a condition that could be treated. It's more likely to be "drug versus drug-we-think-might-be-better". That way, at least you're being treated.

One of the benefits of clinical trials is that participants tend to receive better and more frequent monitoring and screening for all sorts of conditions than the general population do - find out what monitoring and screening you'll be getting not only initially but also during the trial.

A disadvantage of trials, especially long term ones, is that participants can feel chronic anxiety over the nature of the treatment. Talk this through with your doctor beforehand, and don't be shy of bringing it up during the trial if you start to feel it.

Posted by Jengie Jon (# 273) on :

This sounds like a phase III clinical trial, that means that the drug has already been tested twice already see the explanation on Cancer Research UK site. Doctors will therefore have a good idea that it does work and what its toxicity is (also some idea of side-effects).

First in a proper clinical trial you won't be able before signing up to specify whether control or placebo, ideally you should not know, nor should your clinician, this is called double blind which is strongly advised for phase III. Triple blind is when the analyst does not know which group of patients are on the standard and which is the innovative. They will break blindness in the case of severe side effects, Trials are also monitored so if lots of side effects are reported then it will be stopped early.

Now the new treatment is not guaranteed to be better than the old, it may be worse but the researchers hope it is.

Jengie

Posted by Spike (# 36) on :

quote:
Originally posted by no prophet:
Find out who is sponsoring it - drug company, gov't funding agency. But it should be provided in the sign up and screening for subjects/participants.

Very important point. A while ago I signed up to some clinical trials for ex-smokers. Once I realised the project was being sponsored by Philip Morris (one of the world's largest tobacco manufacturers) I backed out.

Posted by Ariel (# 58) on :

quote:
Originally posted by Boogie:
I could withdraw at any time of course if side effects etc occurred.

These would be the visible side-effects that you notice.

Sorry to be negative, but I'd want a lot more information about what exactly was going to be injected, and what the possible risks were. It's not like a skin cream you can wash off. This is going straight into the bloodstream. What effect would this have on internal organs, mental processes, etc? Not just short-term but over a period of several years? How would the substance react with any existing medication that you might already be taking? Has anyone else tried it and have they had any side-effects?

It's in their interests to present the information in a way you will want to hear so that you feel inclined to sign up for the trial. It may be harmless and prove to be safe and helpful. But do check it out very carefully before you commit to anything.

Posted by The Great Gumby (# 10989) on :

The best source of information will be a patient information leaflet which will have been produced for the trial, and approved by an ethics committee as accurate and not misleading. That's the single most important thing to read and check that you're happy with it.

Apart from that, you might want to check whether the new drug's going to be funded by your PCT in the event that it's shown to be effective. It has been known for trials to be very successful, but for PCTs to refuse to fund the new treatment once the trial's ended on the grounds of cost, dumping people back on their old "inferior" drug. It's not likely, but worth asking. (The drug's supplied by the manufacturer for the duration of the trial.)

Above all, you'll be making your own contribution to medical science and knowledge. Every single medicine you've ever taken was once a "new drug", and has been developed through steady steps of investigation. Once it reaches the point of testing it against an existing drug, you can be confident that it isn't obviously harmful (which is very rare anyway - the only case recently was a very big news story), and there's a good chance that it will be superior to your existing treatment. If it becomes clear that the new drug's worse, the trial will be stopped early as a matter of course, because to do anything else would be grossly unethical.

Posted by mdijon (# 8520) on :

Are you able to find a link on the net to the clinical trial website or provide some keywords?

BTW, I don't think it will be possible for the PCT to give an undertaking if the product isn't yet licensed, as it will be unclear what the effect is and what the cost might be.

My bias is that research is a good thing, and that the more we know the better treatment becomes.

Spike gives a clear example of a dodgy-sounding study that I wouldn't want to participate in either, but in general studies that recruit via the NHS are of a high standard ethically, and subject to quite careful national and local review.

Posted by Nicodemia (# 4756) on :

All good advice given, which I couldn't add to!

But [Votive]

for you as you decide, and if you take part.

Posted by Jengie Jon (# 273) on :

Ariel

That is one of the unknown, they know immediate toxicity and trial patients are also more carefully monitored whether on standard or new. However long time effects such as many of them can only be established at phase 4 (see information above), it is normally precisely what phase 4 is about.

Jengie

Posted by The Great Gumby (# 10989) on :

quote:
Originally posted by mdijon:
BTW, I don't think it will be possible for the PCT to give an undertaking if the product isn't yet licensed, as it will be unclear what the effect is and what the cost might be.

Yes, fair point. Thinking too far ahead of myself, and trying to balance my natural instinct in favour of research.

Posted by Jack the Lass (# 3415) on :

quote:
Originally posted by Adeodatus:
One of the benefits of clinical trials is that participants tend to receive better and more frequent monitoring and screening for all sorts of conditions than the general population do - find out what monitoring and screening you'll be getting not only initially but also during the trial.

My current job involves interviewing trial participants, and more than one has mentioned this as a particular benefit of participation.

I would also echo the advice about checking the funders - as already mentioned upthread, if it is funded by the NHS it will have gone through very rigorous screening, checking, hoop-jumping and scrutiny prior to getting anywhere near any patient.

Posted by Boogie (# 13538) on :

quote:
Originally posted by Jack the Lass:

I would also echo the advice about checking the funders - as already mentioned upthread, if it is funded by the NHS it will have gone through very rigorous screening, checking, hoop-jumping and scrutiny prior to getting anywhere near any patient.

Yes - it is funded by the NHS. The study is "Comparing the safety and effectiveness of the investigational study medication to a placebo for moderate to severe psoriasis symptoms"

Thank you so much for all your kind responses - I continue to deliberate carefully.

I'm rushing out now but will answer your questions more carefully tomorrow.

Posted by Doublethink (# 1984) on :

Of course, ending up in the placebo bit in a study is not totally a waste of time - because the reason they have it, is that the placebo will usually have some positive effect anyway !

Posted by Schroedinger's cat (# 64) on :

My initial reaction is go for it - you may get something that really works, before anyone else. And at least, you will be helping with some important research into better treatments.

Having said that, do check up on the details. As others have said, make sure it is for the right purpose - not sponsored by someone you don't agree with. Check all that you can, in terms of possible side effects. If you can cope with doing the injections yourself, then that is a good start, because I know a lot of people who wouldn't (myself and my wife being two).

And do be aware that clinical trials can have serious side effects. It is very unlikely, but these are part of the risk you are taking. There was a case a few years ago of some students who lost their fingers and toes in a trial. They got compensation, but it was part of the risk. However, it was newsworthy because it was the first case of serious side effects in a clinical trial for ten years or more, during which time many hundreds of thousands of people will have undertaken trials.

So my position would be positive, but with appropriate caution.

Posted by iamchristianhearmeroar (# 15483) on :

I guess you should check whether you will have to exclude all other treatment during the trial. Not so great if you find yourself in a placebo group and you're not able to do anything else to alleviate the condition.

Posted by mdijon (# 8520) on :

Normally a trial like this would be done in addition to other standard treatments. So the new drug plus usual care is being compared with placebo plus usual care.

If you play the numbers, I guess one would say that overall most trials are of things that turn out not to work. The doctors are dead keen on new stuff, the guys who designed the molecule think its great, but with the best of intentions only about a third of it turns out to work.

On the other hand, every so often something turns out to have a really serious side effect that wasn't expected. This happens very rarely - I would guess less than 1% for it to be really serious (perhaps 10-20% for it to be annoying but not really serious). If such a serious outcome occurs the likelihood of you being the unlucky one is very low.

So overall there is a modest chance of a new treatment helping you, and a tiny chance of a substantial adverse outcome.

But in the end I think you have to take a decision to participate in research on the understanding that it isn't designed to help you. It is designed to get information that will help other people in the future. So the main part of the decision is altruistic in the end.

Hope this helps.

Posted by Huia (# 3473) on :

I was asked to participate in a clinical trial, but refused because my body doesn't take kindly to new medication. I've already had a life threatening reaction to prescribed medication.

Posted by Boogie (# 13538) on :

quote:
Originally posted by mdijon:
Are you able to find a link on the net to the clinical trial website or provide some keywords?

Yes here is the website quoted on the paperwork.

I think I'm leaning towards going for it.

The thing which bothers me is getting the placebo and the condition becoming worse due to not using my current medication. But I can always withdraw if that happens. But I hope this is the case -

quote:
Originally posted by mdijon:
Normally a trial like this would be done in addition to other standard treatments. So the new drug plus usual care is being compared with placebo plus usual care.

quote:
Originally posted by Schroedinger's cat:
My initial reaction is go for it - you may get something that really works, before anyone else. And at least, you will be helping with some important research into better treatments.

From the descriptions of past trials it looks like it works - this trial seems to be testing time intervals for doses as there are several groups with different intervals from two to twelve weeks.

quote:
Originally posted by Adeodatus:

One of the benefits of clinical trials is that participants tend to receive better and more frequent monitoring and screening for all sorts of conditions than the general population do - find out what monitoring and screening you'll be getting not only initially but also during the trial.

Yes, I like this idea - I'm in good health and not one to worry about it, but it's nice to know your bits are in order! The drug is also intended to be used to treat arthritis, which I also have. So there is a chance of double benefit.

Thanks all for your time and comments, they have been very useful.

Posted by balaam (# 4543) on :

Two phrases:

quote:
Originally posted by Boogie:
I have moderately serious psoriasis.

I could withdraw at any time of course if side effects etc occurred.[/QB]

It's serious and you can withdraw that's what I needed to know. If it were me I'd do it, unless a doctor advised me against.

Of course it's up to you.

Posted by Boogie (# 13538) on :

Thank you all - I have an appointment for a clinical assessment next Tuesday. The person I spoke to said it's 'competitive' as to whether I get on the trail or not - my psoriasis may not be bad enough.

Anyway, I have made the first step.

[Smile]

Posted by Lothlorien (# 4927) on :

quote:
Originally posted by Boogie:
Thank you all - I have an appointment for a clinical assessment next Tuesday. The person I spoke to said it's 'competitive' as to whether I get on the trail or not - my psoriasis may not be bad enough.

Anyway, I have made the first step.

I know what you mean when you say it may not be bad enough, but any psoriasis is too much in my opinion.

[ 03. October 2012, 08:49: Message edited by: Lothlorien ]

Posted by mdijon (# 8520) on :

Indeed, "Bad enough for who?" is the consideration.

Posted by balaam (# 4543) on :

quote:
Originally posted by Boogie:
my psoriasis may not be bad enough.

It might not be bad enough for the scientist conducting the trial, but like all arthritic conditions, it is always bad enough from the sufferers pint of view.

Posted by Josephine (# 3899) on :

quote:
Originally posted by mdijon:
But in the end I think you have to take a decision to participate in research on the understanding that it isn't designed to help you. It is designed to get information that will help other people in the future.

Exactly. If you're in a clinical trial, you are there to help the researchers get information. The information may or may not help you. That's entirely beside the point.

My dad and one of my uncles had a conversation when I was a kid, about what they'd do if they were ever diagnosed with a terminal illness. They both said that they would enroll in clinical trials. If they were going to die anyway, making themselves available as guinea pigs would be a way of giving their illness meaning, of making it worthwhile to endure it.

And, as it happened, they both developed terminal illnesses, and both enrolled in clinical trials. My father's condition was made worse by one of the experimental drugs he took. Well, if you can say that. He was terminal before he took the drug, and terminal after. He just felt worse after.

It was a small trial -- 6 or 8 patients, if I remember right. And not double-blinded; it was an earlier phase in the research. One of the patients in the study showed dramatic improvement -- exactly what the researchers were hoping for. The others either didn't get better, or, like my dad, got worse. That was important information for the researchers. And that's why my dad was in the trial -- not because it would help him, but because it would allow researchers to learn something that would eventually help someone else.

Posted by Boogie (# 13538) on :

I failed the test by two points, this is the first test I've failed for not being BAD enough! - disappointed but never mind. I discovered it was a looong journey to the hospital (well over two hours) so lots of time saved there.

Thank you so much for all your help and support!

[Smile]

Posted by maryjones (# 13523) on :

I have just completed 5 years in a trial for a breast cancer prevention trial. drug trial
MY family history means I am more at risk so the extra supervision appealed to me. There was also the fact that if it worked I would benefit and, in any case, it might help my daughter, nieces and grandchildren.
Would I do it again? Yes.
/Tangent, it amuses me that many people get annoyed over doing tests on animals but do not put themselves forward as experimental fodder themselves

Posted by Ariel (# 58) on :

Well done you for trying, Boogie. Though it has saved you rather a journey, as you say.

Hope it all clears up for you.

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