|
|
Post by puntkicker on Sept 20, 2016 14:55:17 GMT -5
Folks, I was curious what places, if any, you've gotten informed consent forms before the screening? I'll share what I have so far. This was a couple of weeks ago, but as best I recall, I pressed someone from Quintiles with some probing questions and they offered to email the informed consent. I received the pdf file from a link if I recall correctly, and was VERY glad I did. When I saw the side effects for this medication, I knew I didn't want any part of it. I can imagine my reaction if I drove 600 miles(1 way) only to see those numerous possible side effects, including hair loss.
Obviously I wish all places would do this. Which have done it for you? Also, I recall at least one place wouldnt tell me the name of the drug(so that I could research it myself), but I dont recall which clinic that was. If anyone wants to share those places as well, it might be helpful.
I recently drove about 2,000 miles round trip to Covance, and when given a folder to read through, I about bugged out when I saw soing about a SPINAL TAP, which I had not heard mentioned at all. I was thinking maybe I could take the pain for the money, but then I was reading about the possible long term/permanent side effects, and was thinking I'd have to throw out my 2000 miles of driving. Fortunately, it was only for 1 cohort of the study, which I later found out was not mine. What a relief! Maybe this is slightly off topic from my thread title, but I wanted to share the experience with you. Maybe someone will have some feedback.
This idea of helping each other(even the parasitical "guests" lol, who greatly outnumber the rest of us 30:1 maybe) has made me wonder if forming soing like a union would be possible. Yeah, I like thinking big and outside the box, lol.
|
|
FloridaGirl
Full Member
I am new to Phase 1 clinical trials so I am trying to learn as much as I can .
Posts: 160
Location: Florida
I mainly do: Healthy Studies
# of studies I have done: 3
A little about me: I am just getting started in clinical trials . Became unemployed and was doing small outpatient studies until someone told me about Covance and it has ed up a new world of making money.
So I am trying to do more inpatient studies and am hoping to do even more next year.
|
Post by FloridaGirl on Sept 20, 2016 17:33:54 GMT -5
Good question as I am going to Covance to screen next week and I did ask the screener some questions since I, like u don't want to waste my time. The screener could really only tell me how many blood draws. I asked her about the medication and since it is experimental she could not give me a name or info about it. I did not want to press the issue since the days in will work well with my schedule so I will do the study anyways. Fortunately for me Covance is close by, 2 1/2 hr drive, so I won't find out the info I need until I screen. But that is a good point to ask and demand more info when u are traveling far. I will remember that if I screen out of state. And I am also hoping that the side effects are not really bad, the drug I am doing is the first dosing stages so I will find out next week.  |
|
mike
Moderator 
Posts: 334
|
Post by mike on Sept 20, 2016 20:26:43 GMT -5
It's possible that clinics are "required" to tell you everything about the study over the phone, but boy good luck pulling those teeth. That is nice that they emailed you the details.
Whenever I go to Parexel, EVERYTHING changes by the time I show up for screening, it is often practically or literally a different study by then, and then more will change when I show up for check-in. Often the changes I am cool with, but sometimes they are a deal-breaker.
They are the worst about this though compared to other clinics, in my experience.
|
|
|
|
Post by travelingrat on Sept 21, 2016 10:48:39 GMT -5
this is an issue I have actually written the FDA about. many clinics have told me that the informed consent is "privileged info" which is BS. all clinical trials are required to list with the government at clinicaltrials.gov (well I hope I remembered the website name correctly, i'm at the library with a limited amount of time, so cant check it)so the info is already out there! but it is hell (for me at least) to find it as the Study Number a clinic will give one is not the same as the study number on that site. how's that for transparency and making sure we are actually giving INFORMED consent!!!!!
puntkicker, you are right about Quintiles ...they are great about sending on the informed consent, one of the few.
BTW, if any of you have successfully navigated that government site to learn about a study you want to do, let me know. I have struggled for hours over the years with it. maybe it is just me, who knows.
|
|
FloridaGirl
Full Member
I am new to Phase 1 clinical trials so I am trying to learn as much as I can .
Posts: 160
Location: Florida
I mainly do: Healthy Studies
# of studies I have done: 3
A little about me: I am just getting started in clinical trials . Became unemployed and was doing small outpatient studies until someone told me about Covance and it has ed up a new world of making money.
So I am trying to do more inpatient studies and am hoping to do even more next year.
|
Post by FloridaGirl on Sept 21, 2016 18:50:57 GMT -5
this is an issue I have actually written the FDA about. many clinics have told me that the informed consent is "privileged info" which is BS. all clinical trials are required to list with the government at clinicaltrials.gov (well I hope I remembered the website name correctly, i'm at the library with a limited amount of time, so cant check it)so the info is already out there! but it is hell (for me at least) to find it as the Study Number a clinic will give one is not the same as the study number on that site. how's that for transparency and making sure we are actually giving INFORMED consent!!!!! puntkicker, you are right about Quintiles ...they are great about sending on the informed consent, one of the few. BTW, if any of you have successfully navigated that government site to learn about a study you want to do, let me know. I have struggled for hours over the years with it. maybe it is just me, who knows. |
|
FloridaGirl
Full Member
I am new to Phase 1 clinical trials so I am trying to learn as much as I can .
Posts: 160
Location: Florida
I mainly do: Healthy Studies
# of studies I have done: 3
A little about me: I am just getting started in clinical trials . Became unemployed and was doing small outpatient studies until someone told me about Covance and it has ed up a new world of making money.
So I am trying to do more inpatient studies and am hoping to do even more next year.
|
Post by FloridaGirl on Sept 21, 2016 18:51:33 GMT -5
this is an issue I have actually written the FDA about. many clinics have told me that the informed consent is "privileged info" which is BS. all clinical trials are required to list with the government at clinicaltrials.gov (well I hope I remembered the website name correctly, i'm at the library with a limited amount of time, so cant check it)so the info is already out there! but it is hell (for me at least) to find it as the Study Number a clinic will give one is not the same as the study number on that site. how's that for transparency and making sure we are actually giving INFORMED consent!!!!! puntkicker, you are right about Quintiles ...they are great about sending on the informed consent, one of the few. BTW, if any of you have successfully navigated that government site to learn about a study you want to do, let me know. I have struggled for hours over the years with it. maybe it is just me, who knows. |
|
mike
Moderator
Posts: 334
|
Post by mike on Sept 22, 2016 18:43:43 GMT -5
FloridaGirl maybe you could stop using the quote feature so much? Like quoting the complete post right above your post but not even responding to it, like you did above this post.
Also soing I like to do is quote someone, go into the quote and reduce it down only to the actual information that I am responding to. All the quoting just makes the threads unnecessarily long.
|
|
|
|
Post by puntkicker on Sept 23, 2016 2:23:10 GMT -5
FloridaGirl maybe you could stop using the quote feature so much? Like quoting the complete post right above your post but not even responding to it, like you did above this post. Also soing I like to do is quote someone, go into the quote and reduce it down only to the actual information that I am responding to. All the quoting just makes the threads unnecessarily long. Actually, she did that, and then quoted her own post quoting that had already quoted the original, and then didn't respond. For some people getting used to message boards can be hard at first, and possibly more so on mobile devices. I too felt compelled to say soing, as I tend to get excited when I actually see a "new" in the forum list. When there is no message to go along with it, I find it metaphorically similar to blue b***s. Anyhow, I have faith FG will be able to get this down now. FG, let us know the issue and we'll be happy to help(or try at least, lol). |
|
|
|
Post by subject on Sept 26, 2016 0:04:08 GMT -5
I always try to research the drugs that are on clinicaltrials.gov before heading to screen. Most, if not ALL the places do not have up to date listings of the clinical trials at all which is really sad because it is required under law (FDAAA 801). As a matter of fact, only 2 times has it been properly listed out of the dozens I've participated in.
|
|
