Do they ever call to verify with other trials?

[gregdrugguy]

Hey guys,

So I went to a VCT clinical trial and my last dose was April 21. But I had outpatients so technically my participation didn't end until May 17th, a couple of days ago. So I decide because of that I'll just go to a Non-VCT place that doesnt use fingerprint scanning. Cool. Well Im talking to the recruiter and I told him that it wasnt my first drug study no. It was just my first with this particular company. I didn't think anything of it. The study will be in June so well over 30 days from dosing. However this study wants 30 days from last participation, which I could honestly give a **** about. I get why they do it tho.

So anyways we are doing the paperwork yada yada yada and it comes to the Question: Have you ever done a study before? Well I have to answer Yes because i already told the recruiter I had been in one before. No sweat, I check yes. Then on the next page it wants to know the name of the drug, the dosage you took, start and end dates. The whole nine yards. Surprised It didn't ask me how many shits I took or books I read while in the study lol... So I lied. I wrote that it was over a year ago. Wrote some dates down and whatever. But I told him, "Yea I don't remember what the drug acronym was. They didnt have a name, it was letters and numbers."

Thats when he says to me "oh ok well give them a call and they will tell you all that info and you can tell us." So I asked him "You want to call....like right now? and ask?" just you know....trying to time whatever I can. He says "oh nah just let us know the info later when you come in for covid testing or ect..But before the study begins. a nd we will call them and verify all the info"

So couple of questions:
1. Can they even call and verify it? I thought all that **** was confidential and that no info could be given out to anyone except like law enforcement and the FDA?
2. Should I prepare a bogus drug name like [FML-2021] and make up some random low dosage and hope they cant verify?
3. Keep my mouth shut and hope they forget?

Anyone been in this situation? Its in June so ill be well over 30 days from last dose. Sure I shouldn't have lied but I did and now here I am. Any help is appreciated.

[FloridaGirl]

May 19, 2021 16:58:18 GMT -5 gregdrugguy said:

Hey guys,

So I went to a VCT clinical trial and my last dose was April 21. But I had outpatients so technically my participation didn't end until May 17th, a couple of days ago. So I decide because of that I'll just go to a Non-VCT place that doesnt use fingerprint scanning. Cool. Well Im talking to the recruiter and I told him that it wasnt my first drug study no. It was just my first with this particular company. I didn't think anything of it. The study will be in June so well over 30 days from dosing. However this study wants 30 days from last participation, which I could honestly give a **** about. I get why they do it tho.

So anyways we are doing the paperwork yada yada yada and it comes to the Question: Have you ever done a study before? Well I have to answer Yes because i already told the recruiter I had been in one before. No sweat, I check yes. Then on the next page it wants to know the name of the drug, the dosage you took, start and end dates. The whole nine yards. Surprised It didn't ask me how many shits I took or books I read while in the study lol... So I lied. I wrote that it was over a year ago. Wrote some dates down and whatever. But I told him, "Yea I don't remember what the drug acronym was. They didnt have a name, it was letters and numbers."

Thats when he says to me "oh ok well give them a call and they will tell you all that info and you can tell us." So I asked him "You want to call....like right now? and ask?" just you know....trying to time whatever I can. He says "oh nah just let us know the info later when you come in for covid testing or ect..But before the study begins. a nd we will call them and verify all the info"

So couple of questions:
1. Can they even call and verify it? I thought all that **** was confidential and that no info could be given out to anyone except like law enforcement and the FDA?
2. Should I prepare a bogus drug name like [FML-2021] and make up some random low dosage and hope they cant verify?
3. Keep my mouth shut and hope they forget?

Anyone been in this situation? Its in June so ill be well over 30 days from last dose. Sure I shouldn't have lied but I did and now here I am. Any help is appreciated.

[FloridaGirl]

Do you remember a study u did last year that u could use. IF they insist then have them call that facility.
I usually keep my consent forms in a folder so if u have one from last year u could use that for the info.
Don't use the study u just got out of if u were not 30 days post last follow up visit not worth taking a chance.
And it seems like they can't call a clinic about yr previous study anyway.
I have never had that happen.

[travelingrat]

i have never had a non-vct clinic ask me anything except "have i done a study in the last 30 days" and i always say no.

do you know any other lab rats who could tell you the name of a drug they took last year and the clinic? you could possibly use that info for yourself.

legally i cant see how they can call and check unless you sign soing giving them permission. but maybe they are figuring that it would be hard for you to find a lawyer to take your case and then prove in court that they did that ... maybe asking questions and making subsequent phone calls is their answer to VCT which a clinic must pay fees for ...it is not free to them.

[simonsays]

First of all, you should not be sneaking into another study like that. They're trying to get these drugs approved to help people, and any artifact in your labs or ECGs could delay or prevent the drug from making it to market. But, to be honest, I think we've all done that, at least once, especially those who have been doing these studies for a long time. But it's food for thought.
Second of all, you shouldn't have told them that the drug's name was just letters and numbers. Drugs with names like fumylifimen are drugs that are out on the market, the clinics can easily look up any information they need on those drugs on the internet. If the drug's called soing like FML-2021, the information that the clinic needs is not readily available, and they might need to make a few phone calls to get more information on it. Information they're probably looking for is definitely the half-life, and maybe the activation pathway, drug class, and other things that I don't quite understand.
Third of all, be careful doing this: for your own health, but also consider the possibility that in a year clinic A gets bought up by clinic B, and so when they combine the data that they've collected on their lab rats your name gets redflagged in their system as someone who jumped studies before the washout period was complete.
The clinics are not allowed to share information without your permission, but watch what you sign at the screenings, because one of those forms may have done just that. Worldwide Clinical Trials always struck me as shady because (among many other reasons) they make you sign a blank HIPAA release form at screening.
I would look closely at your screening paperwork and www.clinicaltrials.gov to see what, exactly, the exclusion requirements are for your new study, and then make sure that whatever information you give the clinic doesn't exclude you. Does the study exclude anybody who received a CYP-inhibitor or a monoclonal antibody in the previous year? If so, make sure that FML-2021 isn't one of those drugs. That sort of thing.

[gregdrugguy]

May 21, 2021 18:12:06 GMT -5 simonsays said:

First of all, you should not be sneaking into another study like that. They're trying to get these drugs approved to help people,

First of all, I'm not sneaking anywhere. Its been 30 days since my last dose, like I typed. Just not 30 days since my last participation (outpatient). The drug would be well out of my system at that point. Second, I didn't ask for any moral standings. Pharmaceutical companies don't try to get drugs on the market to help people. They do it for money.

[travelingrat]

to simonsays: the issue for me is that the VCT guidelines are set in stone and often illogical. for example, many clinical trials are for drugs that are already on the market and the pharma wants to list them as useful for other conditions, so they are required by the FDA to have another clinical trial. i have been in trials where the drug has been on the market for years and is out of the body in hours, completely out in days, and then had the phone call on top of that, all of which prevented me from getting into a super good trial. and it was one which needed healthy elderly who do not have conditions or take prescription drugs (or anything else of course).

to me it was Lose/Lose all around.

furthermore it takes 12 - 15 years to get most drugs on the market. they will be tested and re-tested.

and finally, i have yet to meet a participant who did not conceal soing from his or her health record or have a convenient memory lapse. if you are completely honest, you are in a very small group of volunteers. just my opinion of course .... but i have been doing clinical trials for years and swapping stories with other lab rats all that time. as a low-income person, i have had a lot of jobs that were not very good for my physical well-being, especially my back. so it goes .... as Kurt Vonnegut used to say. i have zero qualms in trying to get around totally illogical rules.

[simonsays]

To the Greg guy:

If you're not sneaking, then why are you on this website asking for how to get into a study in violation of that study's inclusion/exclusion criteria? If you're not sneaking, then why don't you provide more details: like the names of the clinics, the names of both study drugs, the name of the fake study drug that you plan to tell the clinic, etc, so that the people on this board can give you a definitive yes or no on whether or not you can get away with your stated plan. If you're not sneaking, then you should be able to ask these questions directly of your study recruiter.
And you're right that pharmaceutical companies only care about the money, but study doctors, researchers, study participants, etc are humans, too, and they may be motivated by more than just money. And, even if they were only motivated by money, it still wouldn't change the fact that your actions could still affect whether a lifesaving drug or life-changing drug makes it to market. But that depends on the study that you're talking about. You haven't provided enough details. Is the study that you're trying to get into a study to measure the bio-equivalence/bio-availability of an FDA-approved medication intended to treat alopecia, or is it the first cohort in a first-in-human study of a first-in-class biologic that shows promise for treating child with bone cancers?

To Traveling Rat:

This thread isn't about VCT, so much as it is about the specific inclusion/exclusion criteria of the clinic. I definitely have my issues with VCT, and I don't know if I didn't make it clear in my earlier post, but I've been in Greg's exact position before, and I've successfully snuck into the study a few times, so I don't know why everyone is getting all defensive about this. But these are important things to bring up, which I find that many "study hoppers" tend to ignore.
So in Greg's case, it's the study team (not VCT) who is trying to collect specific information about the last dose to determine if that specific drug, taken at that dosage, that long ago will disqualify Greg from their study. As far as I know, VCT doesn't care about such complexities. I'm not sure, though, so correct me if I'm wrong.
I know that some studies are "easy" studies (see my alopecia example at the end of my reply to Greg in this same post). But that being said, Greg did not specify whether he is trying to get into one of those studies. So let's assume, just for the sake of argument, that it's the other extreme (the bone cancer study mentioned above).
If the drug is that new, and is that early in clinical trial phases, then there is no guarantee that the drug will be "retested" as you say. Drug companies abandon drug trials all the time, specifically because drug trials cost money, and, as Greg said, the companies only care about money. So if it's a newish pharmaceutical company who is starting first-in-human trials for two similar bone cancer drugs, and one shows worrying changes in platelet counts, whereas the other one doesn't, they are more likely to drop that drug and ue with the other one if they're presented with money constraints.
But if those changes in platelet numbers were due solely to two subjects (out of ten total subjects in that first group) jumping between studies, then that's a shame, and that's soing to think about.
Even though the drug may be long out of your system, your system may still be adjusting. Again, going back to the truism that pharmaceutical companies are only out for the money. There's a reason why Greg had his last outpatient visit so late after the drug was supposedly cleared from his system. Why would the pharmaceutical companies be paying for that last outpatient visit if it was completely unnecessary? They are, after all, only in it for the money.
And I understand that there are many lab rats who do this all the time. And, again, let me be clear, I've done this as well. I totally understand that these clinics do not pay us a "living wage", especially for career lab rats who are supposed to adhere to washout periods and half the time don't know when they're getting their next check.
But, a little off subject, I'm curious if you've really been talking to all the participants, or if your assumption that all participants conceal or have "convenient memory lapses" is due to some sort of sampling error. Study clinics are a lot less cliquey than other environments can be, but there are still definitely social groups that form. If your "group" in studies is the group of "traveling rats", then you might be getting a skewed impression of study participants as a whole.
Anyway, I put this out there, because I think it is important for people to think about how their actions do sometimes have a ripple effect. It stimulated discussion, and hopefully more people chime in with more ideas and arguments and perspectives.

[gregdrugguy]

Nobody got defensive. I told you not to tell me anything about morals or what I should and shouldn't do. Thats up to me. it was never part of the original post. I never asked "Should I do this? Is this right?"

[simonsays]

Ok, I understand now. So I hear you when you say that you didn't come on here to hear about the moral implications. But I'm not sorry for giving you my opinion on that.
Anyway, after the study is over, can you give the forum an update on what happened: What information did you end up telling the study recruiter? Did they press you for more details on anything in particular? Did you get into the study? Did you dose? etc

[travelingrat]

Hi, i agree it wasn't a VCT thread but i felt that issues of verification were raised so i felt it was at least somewhat relevant. but i agree, not on target.

Regarding whether my beliefs about volunteers and honesty are possibly skewed: well it is certainly true that i do not talk to every participant in every study i have been in LOL. however i have been a participant in a lot of clinics in different states, and many of the studies were looooong ones where people do tend to reveal a lot....plus i like people and talk to most everyone i can.

interestingly, some of the studies i have done with older women with stable lives, homes, husbands, that is, participants whom one might think would be more study-compliant, were as deceitful as any "professional" lab rat out for as much money as possible. i think that most people feel that with Phase I trials, does it make a lot of difference?

unfortunately over the years, i have witnessed so much bad stuff happening to volunteers (myself included) that should never have happened that my sympathies are entirely with the deceptive practices of the volunteers. and yes, i am digressing; there is way too much to discuss regarding how volunteers are treated and how that treatment ultimately results in deceptions of many varieties. and it is so hard to get anyone to listen! when i first started, i wrote long detailed letters to the FDA, Health and Human Services, etc. and did not even receive form letters back. sadly the IRB's are mostly useless as well. Volunteers have so little protection in so many ways.

re whether a person might suffer physical harm by not being truthful, there is so much potential for physical harm in so many jobs for low-income persons that i wonder how much difference it makes. but yes, it is good for all of us to think about the effects of our chosen endeavors - whatever they are - on our physical and mental selves. and it is good that you touch on this.

and gregdrugguy, i too hope you share an update!

[vark]

i've done 50 studies, and there was only one time that at a screening they tried to get all the info about my previous study. we went back and forth about it for awhile, with my position being that's confidential information i can't give out. eventually they settled for being assured i was well past any washout/halflife period and was ok to do the study, but it almost cost me the study. just somebody being overzealous. in general, they want to verify you are coming in clean with nothing residual still in your system. some places go from dose date to dose date, while others go from end of study date.

one time i wasted a drive to kc because they wouldn't let me screen during the 30 days, even though the study start was more than 30 days. one time i wasted a drive to fargo in january because they didnt tell me the study was cancelled. that one was partly on me for not calling before driving.

[labrat1]

I wrote on a different thread about one of my experiences with VCT. Try the link below to see that one and hopefully the link works.
But I have never had such an "extensive" issue with VCT. That is, when I went through the consent process and it included VCT, I was not asked for specifics about what study drug I was dosed with in the last study I participated in and what it's official name was etc etc. Ever since VCT was instigated I only was given a paper that explains what it is and that I have to sign it along with the consent so that the study staff can look up when I did my most recent study.

Oh, in the link below one of my posts tells of a rather good experience I had with VCT. It should be the very last post as of this time.
But another story comes to my mind now. I can only describe it generally. I was chosen for a study that involved cognitive testing and wearing of a "EEG CAP." Over phone I was told that the cognitive testing would not be very long. (Cognitive tests can be horribly tedious and takes hours and is psychologically torturous and unless I am desperate I would often not choose a study with cognitive testing even with fairly good pay and this one paid about $3000 for roughly a week and a half stay, or that is roughly how I can now recall it). However It turned out that the cognitive test was indeed long and exhausting but I just told myself that I will put up with it for the money, but then what happened is that the company that manufactures the EEG CAP (some thing that is put on your head that has certain electrodes or wires to read your brain waves or some thing like that) had their staff person come to place the EEG cap on my head. She had me go through even a completely different kind of cognitive test that was overall more torturous. I did not have to figure out any numbers or look at paint squiggles on paper or look at different people's faces to determine a slight difference in expression (as cognitive tests tend to be designed) but I had to watch a few half-hour long Tom and Jerry cartoons with the EEG cap very tightly on my head. I was told that the cap has to be tight or it won't work. I managed to go through about an hour or maybe an hour and a half with the cap causing me lots of pain. Then what was to be done is that I was to have an IV placed on me and I was to be infused with some substance and I cannot recall what it was but it was not the study drug, not yet.
Then I was to watch the cartoons for about another hour with the EEG cap on my head. I am not sure why the study was designed like this but I think it had to do with studying the ability to concentrate or remember.

What happened is that the cap cut off circulation in my head to the point where I was about to pass out. I tried to ignore the pain and the dizziness and I tried to concentrate on watching the cartoons on a small computer screen but I started to feel so ill that I was about to throw up. The staff had to take the cap off my head and tell me that the study cannot go on because I am experiencing particularly bad effects and the schedule of the study was such that this part is only a "short day" in which I would have to stay a few hours with the cap on my head and watch a few hours of cartoons but later on , the last part of the study will have me staying at least two times as long with the EEG cap on my head and watching cartoons and this will be besides the other long tedious cognitive tests and since I was unable to endure the tight EEG cap it just does not seem do-able for me to try to carry out the rest of the study. The people from the EEG-cap company told me that their test is completely different from the test that the research site or the sponsor has volunteers going through ( the consent form mentioned nothing about that so that was outright trickery but at the time I found no way to address it).
So I could not do the study ( and I did not want to at this point). The people from the EEG cap company told me that most other people they tested, though they felt different levels of discomfort and pain, did not experience what I experienced.
But I talked with the coordinator. I told her that now that I had done this much of the study, I had done cognitive tests and I had spent a few hours with the EEG cap on my head and I was even infused with some kind of medical type substance and now I probably am registered with VCT that I had participated in this study even though I did not actually get to complete it. The coordinator told me that I can go ahead and try for another study and that VCT will not have anything stating that I had participated in this study because actually I had not. Not according to the criteria of the research facility: I was not dosed with the study drug itself and the few days I was in the facility doing cognitive tests and maybe getting blood draws have nothing to do with actually being dosed.
The coordinator told me that if VCT were to call her she would just say that the volunteer did not get dosed and can participate in other studies, there is no washout.

So in a certain way, this research site did pull a fast one by not telling me that they will have a EEG company doing a different cognitive test from that that the research facility and the sponsor intended to do in the study ( I think it was an Alzheimer's study and a study this horrific should pay more than $3000 IMO ) but they were fair and cooperative about making sure that since I did not really participate, then there is no need to have VCT say that I have to wait 30 days until I can do another study.

( What I did is that I found out about the company that manufacturers the EEF cap by looking them up online. I wrote their company a letter telling them that they should try selling their device to the CIA because I am sure it would be a more effective torture device than water boarding. I'm not kidding).

jalr.proboards.com/thread/2114/vct-clinics-sharing-info-hippa?page=1&scrollTo=7813