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Sun Mar 22, 2020, 07:30 PM

Has anyone here ever been in a medication trial? Because I have.

In the early aughts, my doctor asked if I would be interested in helping to test a new medication for the chronic condition I suffer from.

I said yes, of course... it's a miserable thing and if there is a chance at developing a better medication than the unpleasant, side-effect-ridden array currently available, it'll help millions, and I'd be proud to be part of that.

That was only the beginning. I had to schedule a two-hour screening appointment to answer questions and have a basic physical-plus-EKG to determine whether I was a suitable test subject.

Having cleared that hurdle, I had ANOTHER, more in-depth physical with a whole battery of tests (just about every kind of fluid the body secretes was sampled and examined, I think...) to establish baseline this-and-that.

Having completed that, I had to attend a 2-hour educational briefing on the trial itself, the medication protocol, "trigger" indicators for leaving the trial, etc. I was informed that there was no way for the doctor's office to know whether the medication they were giving me was active or placebo, so they would be treating me as though it were active.

I signed a bunch of paperwork, was given copies, plus a "guide" for test participants that included pretty much all the information that had already been given me in the briefing. Then I was given my first week's worth of dosage and a daily log to complete, and an appointment was scheduled for me to bring in the log, have a brief exam, and receive my next set of doses and log.

And that's how it went, for a couple of weeks. Since I know I'm extremely susceptible to the placebo effect, I was not too concerned when some side effect symptoms initially manifested. I logged them, but downplayed their impact/severity (on a scale of 1-10, I reported them as "3", but I was wrong to do that. They were beginning to really affect me.)

Finally, a few weeks in, my Dear Esposo sat me down and had a little talk with me. And demanded that I bring him along to the next weekly appointment.

By that time I was pretty miserable and I did not protest being pulled out of the trial, even though I wanted very much to be part of finding some wonderful new medicine.

My doctor was very apologetic that he hadn't probed deeper on those "3"s, and reassured me that in fact, I WAS an important part of the trial. Finding out how many people were made seriously miserable by the side effects was a critical function of the trial itself.

Fortunately none of the side effects I experienced resulted in any long-term or permanent damage.

But for anyone who thinks "human trials" is something that can be implemented quick n' easy with a telenovela ending, let me set you straight:

Human trials take time and effort and great skill to do correctly and yield accurate, reliable, and replicable results. The role of human subject is not easy or simple, and it imposes risks and often involves effort and pain.

This is a big part of why we only do human trials when the medications have been extensively tested in other ways, and why so many promising medications fail to make the grade in the human trials stage.

It's not something you can just... do.

Only a complete blithering ignoramus would think otherwise.

Oh, wait...

wearily,
Bright

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Reply Has anyone here ever been in a medication trial? Because I have. (Original post)
TygrBright Mar 2020 OP
CaliforniaPeggy Mar 2020 #1
TygrBright Mar 2020 #2
CaliforniaPeggy Mar 2020 #4
CountAllVotes Mar 2020 #3
drmeow Mar 2020 #5
Midnightwalk Mar 2020 #6
drmeow Mar 2020 #9
Midnightwalk Mar 2020 #10
KT2000 Mar 2020 #7
Mossfern Mar 2020 #8

Response to TygrBright (Original post)

Sun Mar 22, 2020, 07:35 PM

1. Thank you, my dear TygrBright, SO MUCH.

Both for your participation and for your telling us about it.

That takes courage, and you have plenty of it!

It's really important to let people know just how serious a step like this actually is.

Blessings on you!



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Response to CaliforniaPeggy (Reply #1)

Sun Mar 22, 2020, 07:39 PM

2. Thank you, dear CaliforniaPeggy... you are a bright Light here. Stay well! n/t

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Response to TygrBright (Reply #2)

Sun Mar 22, 2020, 07:49 PM

4. Your kindness touches my heart.......I am well, and hope to continue so.

Thank you, dear TygrBright!

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Response to TygrBright (Original post)

Sun Mar 22, 2020, 07:49 PM

5. While I do not dispute the blithering ignoramus characterization,

What it takes to conduct a clinical trial varies tremendously! It depends on whether there is an existing treatment or not. It depends on what the phase 1 and 2 trials told the researchers before they started the phase 3 trial. It depends on what the intent of the drug is - prevention, treatment, cure, or other.

When the situation is life or death things are very different in clinical trials than if it is a new treatment for a chronic condition.

How do I know? I have worked as a clinical research coordinator and manager and am currently the ClinicalTrials.gov administrator for all the non-cancer trials at a teaching hospital which has just been added to 2 nationwide COVID-19 clinical trials.

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Response to drmeow (Reply #5)

Sun Mar 22, 2020, 08:00 PM

6. Does the target group matter?

Would the criteria for using results be different if the target is hospitalized patients or healthcare workers rather than prophylactic use?

Id expect so but have no expertise.

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Response to Midnightwalk (Reply #6)

Sun Mar 22, 2020, 09:00 PM

9. I'm not an FDA expert so there are big gaps in my knowledge but

I know that there are a few things that matter

1) Is this a brand new drug or is it a trial to test for a new use or indication for an already approved drug? The COVID-19 clinical trials are a new use for existing, already approved drugs. These are HIV and other anti-viral drugs. That makes it MUCH easier. For one thing, we know the toxicity, side effects, and contraindications for these drugs. We have a great deal of data on them already. There have already been trials at all 4 phases for these drugs. If the drug company wants to get FDA approval for the new use, the hoops are a little more involved. But if a researcher wants to test the drug for a new use but doesn't want FDA approval for new labeling, etc., there are virtually no barriers as long as the human subjects review board (IRB) considers the benefits to be greater than the risks.

2) Are there other treatments? Currently there are no known treatments for COVID-19 except symptom management. That also moves the bar. If there is an existing treatment you have to compare the new treatment to the existing treatment.

3) How lethal is the disease? This one is proving to be very lethal. That also moves the bar.

Both 2 and 3 are where hospitals are use an FDA "loophole" (if you will) known as "right to try." They can file emergency paperwork with the FDA and with their IRB to use a drug they believe will save a patient even if the drug has not been approved. This is more likely to occur with cancer drugs or emergency room situations where its the last resort.

Of course, if 1 is true then they don't need to use right to try - MDs can prescribe a drug which is FDA approved for anything if they think it will work!

4) Do we have historical data which tells us what happens without the drug? China, Italy, Iran, Seattle, New York, and Boston all provide us with data on what happens when we don't treat COVID-19 (assuming we can get China and Iran's data). That means that they can do a single arm, historical control trial. I don't know what they are doing because I haven't yet gotten the information on the trials we're involved with but my guess is that is the design they are using. It is not the perfect controlled trial but controlled trials have their own limitations related to what happens in the real world. Single arm, historical control trials are becoming more and more common because they increase real world validity of the trial without significantly reducing the outcome validity.

Target population is not really a factor, treatment vs prophylactic is.

Edited to add: Also - vaccine trials are different from treatment trials. I've never been involved in a vaccine trial.

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Response to drmeow (Reply #9)

Sun Mar 22, 2020, 10:00 PM

10. Thanks for such a detailed interesting answer! nt

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Response to TygrBright (Original post)

Sun Mar 22, 2020, 08:05 PM

7. I hope they don't rush it

The polio vaccine in its early stages left people with paralysis that lasted their whole lives. We learn from experience what it takes to get a safe vaccine.

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Response to TygrBright (Original post)

Sun Mar 22, 2020, 08:10 PM

8. I volunteered to be part of an

Alzheimer's drug trial. I went through the screening that you did plus an MRI of my brain (never thought of my brain being unremarkable would make me happy) and eventually had a PET scan of my brain. Had to go through some serious cognitive tests and suicide screening.

I was rejected from the study because beside having one gene that indicates a propensity toward the disease, I had no symptoms or other indicators. It's good that I was rejected - they halted the study because they found the test drug brought on Alzheimers symptoms!

I got a second request to donate my brain ... I seriously considered it, but opted out.
My mom succumbed to Alzheimer's.

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