Clinical Studies

[rem74]

Has anyone done a clinical study?

I'm enrolled in one for preventative medication for heartburn.  The medication is approved in Europe, but they have to do this study to get it approved by the FDA so that it can be prescribed in the US.  The medication works well (at least for me), but the clinic seems poorly run.  I guess I benefitted from their disorganization, in a way, since for the first 2 visits they paid me twice. The payments come through deposits onto a debit card thing.  I wish the money was in the form of a check or direct deposit, but oh well.  

I was kind of annoyed that in the first batch of paperwork, it looked like the study would only go on for maybe 6 or 7 months, but then they extended it out to like 1 year.  Which is more medication & symptom diary entries and office visits.    I think the study was only supposed to pay $1150 or so, but with extending it out, it might be more.

The first few visits, the waiting room was quiet.  But today, there was a this really loud talking woman who was on her cell phone, and from her half of the conversation, she was either offering to give away or sell food stamps (I'm leaning toward sell...).  And she was talking about this other study she had done at another clinic, and mentioned she was also doing another study along with this one.  Which seems like it would be unwise to do.   I guess this lady probably doesn't have a job, so this is her main source of income?  

Anyway, if you've done a clinical study, what was it for, did the clientele at your clinic seem kind of downtrodden, and would you do it again?  Also, what method of payment did you get?

[pulmonarymd]

My wife has been a clinical coordinator for a number of clinical studies over the last 30 years. That appears to be a poorly run site. Also seems to be one funded by a drug company. Like everything else there are varying levels of professionalism and competence

[billisonboard]

Jun 30, 2023 17:55:37 GMT -5 pulmonarymd said:

My wife has been a clinical coordinator for a number of clinical studies over the last 30 years. That appears to be a poorly run site. Also seems to be one funded by a drug company. Like everything else there are varying levels of professionalism and competence

Does it make sense it isn't "blind"? (rem74 says in OP medication is working)

[pulmonarymd]

It isn’t likely that it is being compared to placebo as there are effective therapies for heartburn, unless it was advertised for people who were intolerant or had failed other treatment. If that is the case, don’t discount the placebo effect

[rem74]

They said I could get the placebo, and it is possible I did.  But I don't think I did, because its been a month, and no heartburn, when I use to have it daily.  

[Knee Deep in Water Chloe]

I had wretched heartburn last night, and it lasted an hour. I'm glad you've gotten some relief. 


In answering your question, no I've not. However, my son did when he was in college. He had grass or something injected into his arm once per week for several weeks. He was paid $1000. It was a solid college kid income plan. 

My husband signed off on participating in a study when he had prostate cancer, but I don't recall that having to do with treatment. It was when they removed his prostate, the kept some of it for a research project. He was not financially compensated. 

[chiver78]

Jun 30, 2023 18:10:21 GMT -5 pulmonarymd said:

It isn’t likely that it is being compared to placebo as there are effective therapies for heartburn, unless it was advertised for people who were intolerant or had failed other treatment. If that is the case, don’t discount the placebo effect

 this. my first thought was to ask what company/product, because I'm nosy. 

as far as the trial itself, you're getting off light. if it's already approved in the EU, the trials here in the US aren't going to be nearly as invasive as the FDA/EMA lean on each other a bit for approvals. 

I've never done a clinical trial, as either a scientist or a subject, but I do work with product and market launches once those approvals have come back. I doubt I'm the target of your questions, but let me know if I can answer anything about the process. 

[The Walk of the Penguin Mich]

I have been both a patient and coordinator of clinical studies.  I did dental studies, drug studies, metabolism studies and I was a normal blood control for studies where they were looking at changes in blood cell subsets.  I guess the biggest study I did as a patient was a drug study looking at the delivery system of a pain killer used during delivery.  That study paid out about $2000 (which was taxed).  The smaller studies I did over the years paid for a trip to Turkey, Greece and France.  I can’t ever remember a study being anything but well run, with the coordinators competent.  

The clinical studies I coordinated had less than stellar participants.  Most lied on their intake forms, especially about drug, alcohol, week and nicotine use.  We did studies looking at smoking, preterm birth and periodontal disease, and several smaller studies.  Studies where we recruited from the medical center were probably the better subjects.  When we had to go out into the community is when we got a lot of the sketchy participants.  

[The Walk of the Penguin Mich]

Jun 30, 2023 18:02:28 GMT -5 billisonboard said:

Jun 30, 2023 17:55:37 GMT -5 pulmonarymd said:

My wife has been a clinical coordinator for a number of clinical studies over the last 30 years. That appears to be a poorly run site. Also seems to be one funded by a drug company. Like everything else there are varying levels of professionalism and competence

Does it make sense it isn't "blind"? (rem74 says in OP medication is working)

It is not hard to determine if you are in the experimental or placebo group,  In the drug study I did, everyone hurled who got the drug.  I got the placebo.  Another study I did looked at a chlorhexidine mouth rinse.  I got the experimental, as it stained my teeth.

[finnime]

I've done one clinical study extended from 6 months to 2 years. It was for an injection once a month for arthritis in the knees. You had to keep a daily diary of pain and use of supportive meds that they supplied, which was Aleve. I found the trial drug very helpful. I was on a medium protocol. Unfortunately they found too many problematic side effects in the high dose protocol and the product was shelved.

I didn't know absolutely that I was on the actual drug; it was a double blind study. I did find my pain was relieved 2 months in and it remained in remission for the duration +. Now I hurt again. I did get paid, a total of $4000 or so for the 2 years. They paid by ECF, just like a job.

Other study participants seemed to be mosly like me, genuinely wanting some relief if it could be had. It did no strike me that it was a lot of commitment for anyone wanting just $.

[Deleted]

I received a message yesterday from our medical clinic asking if I wanted to participate in an un-compensated, 2-year study related to finding cancer markers through blood tests.  Monthly blood draws required.  I declined.  

Today they messaged me about participating in a trial of some sort of new product to detect colon cancer.  Also un-compensated.  Monthly stool collection required.  Declined that one too.

I do recognize that many studies are struggling to be adequately representational of senior citizens of various ethnic backgrounds but I'm terrified of doctors, tests, outcomes and medications.  Sorry, world, I can help with this.  

[haapai]

Jul 6, 2023 15:32:37 GMT -5 soupandstew said:

I received a message yesterday from our medical clinic asking if I wanted to participate in an un-compensated, 2-year study related to finding cancer markers through blood tests.  Monthly blood draws required.  I declined.  

Today they messaged me about participating in a trial of some sort of new product to detect colon cancer.  Also un-compensated.  Monthly stool collection required.  Declined that one too.

I do recognize that many studies are struggling to be adequately representational of senior citizens of various ethnic backgrounds but I'm terrified of doctors, tests, outcomes and medications.  Sorry, world, I can help with this.  

I'm not sure that you should be apologizing for anything.  You seem to have declined to pa rticipate in two uncompensated trials that asked for monthly blood draws or monthly stool samples and didn't offer you anything like access to a scarce or experimental drug either..  The monthly stool samples might have been easy to provide but those monthly blood samples can take up some serious time.  If I were ever offered the opportunity to participate in a similar trial I would probably refuse just because the results would be extremely skewed.  I would not want to be a part of such BS.