|
|
Post by labrat1 on May 26, 2021 18:41:47 GMT -5
Or so I would say. I don't think I have ever seen an article address this issue regarding clinical trials, not like this. I don't think anyone else posted this link in JALR. Let me know. It seems this article dates back a few years. Not sure. www.ncbi.nlm.nih.gov/pmc/articles/PMC4520402/ |
|
|
|
Post by ac on May 31, 2021 7:33:23 GMT -5
Seems like a mostly accurate article although things vary from clinic to clinic. Subjects definitely do break too many rules which have a negative effect on the studies. They smuggle stuff in, they do multiple studies at one time with too little gap between study drugs. They make too much noise keeping other subjects from sleeping which can cause inaccurate data for the study. Lots of things subjects do that they shouldn't. Also clinics do things they shouldn't. I have stopped going to Spaulding since they have mandatory 100% consumption of almost every meal for almost every study. They say it's sponsor ed but that is obviously a lie. Other clinics almost never have forced consumption of food except for the very rare case where a study actually does require a high fat breakfast of the study is actually designed to determine if food effects the way the drug works or impacts the body but those are rare and food should not be 100% required for most studies. I no longer go to those clinics that require it for no good reason. Spaulding also started to require people to get naked and put on a single small gown with no foot coverings to do urine tests. They want you to walk in front of all the other people wearing almost nothing and walk barefoot where everyone else walks barefoot including in the bathroom. No acceptable and I won't return until they change the policies. That is one example where clinics don't treat subject like humans. SO there is a lot that can be improved both from the clinics and the subjects. This article is not far off from reality.
|
|
|
|
Post by labrat1 on May 31, 2021 8:07:31 GMT -5
Amazing.
I have not done studies in each and every facility but I dare say it is rare that a clinic makes volunteers put on a gown among other volunteers for urine tests.
All clinics I went to allow you to have your regular clothes on for tests and the physical.
Since clinics are not very regulated by any agency I guess there is nothing "illegal" out-rightly about treating the volunteers like prisoners who have to strip in front of each other, but there is definitely some thing unethical and inappropriate. I have been in clinics that don't initially take privacy into consideration and sometimes do things like have you talk about your AE's in front of other volunteers but when I request to talk about them in a different room from other volunteers, the staff , however grudgingly, honor the request and talk with me in a secluded room because I say that my private medical information should not be heard by anyone who is not a medical staff member.
But somehow regarding this part of Spauldings practices, if the right complaints reach the right people I think that this is some thing more legitimate than other complaints to bring up. After all keeping people barefoot on a floor that is not cleaned is a health hazard also putting volunteers to be nearly naked in front of each other is not what most clinics do.
Whether anything is done or not may be another thing
|
|
|
|
Post by ac on May 31, 2021 8:19:15 GMT -5
Amazing. I have not done studies in each and every facility but I dare say it is rare that a clinic makes volunteers put on a gown among other volunteers for urine tests. All clinics I went to allow you to have your regular clothes on for tests and the physical. Since clinics are not very regulated by any agency I guess there is nothing "illegal" out-rightly about treating the volunteers like prisoners who have to strip in front of each other, but there is definitely some thing unethical and inappropriate. I have been in clinics that don't initially take privacy into consideration and sometimes do things like have you talk about your AE's in front of other volunteers but when I request to talk about them in a different room from other volunteers, the staff , however grudgingly, honor the request and talk with me in a secluded room because I say that my private medical information should not be heard by anyone who is not a medical staff member. But somehow regarding this part of Spauldings practices, if the right complaints reach the right people I think that this is some thing more legitimate than other complaints to bring up. After all keeping people barefoot on a floor that is not cleaned is a health hazard also putting volunteers to be nearly naked in front of each other is not what most clinics do. Whether anything is done or not may be another thing Sorry I wasn't more clear but you do get to undress in a private room one person at a time. You "just" have to walk naked with one small gown on in front of other people for the few feet from the changing room to the bathroom and back to the changing room. The barefoot part is the main reason I said no and withdrew from the study. I asked if they could inspect my socks and then let me put them back on but they said I had to be barefoot which is inexcuseable IMO. Maybe they have changed the policy since then since that was the first day of the new policy. However, the 100% food and the fact that they would ever think the barefoot and nearly naked thing is in any way ok is enough for me to find somewhere else to go even after doing over a dozen studies there over almost a decade. |
|
|
|
Post by ac on May 31, 2021 8:22:34 GMT -5
Amazing. I have not done studies in each and every facility but I dare say it is rare that a clinic makes volunteers put on a gown among other volunteers for urine tests. All clinics I went to allow you to have your regular clothes on for tests and the physical. Since clinics are not very regulated by any agency I guess there is nothing "illegal" out-rightly about treating the volunteers like prisoners who have to strip in front of each other, but there is definitely some thing unethical and inappropriate. I have been in clinics that don't initially take privacy into consideration and sometimes do things like have you talk about your AE's in front of other volunteers but when I request to talk about them in a different room from other volunteers, the staff , however grudgingly, honor the request and talk with me in a secluded room because I say that my private medical information should not be heard by anyone who is not a medical staff member. But somehow regarding this part of Spauldings practices, if the right complaints reach the right people I think that this is some thing more legitimate than other complaints to bring up. After all keeping people barefoot on a floor that is not cleaned is a health hazard also putting volunteers to be nearly naked in front of each other is not what most clinics do. Whether anything is done or not may be another thing (not letting me post clinic name but Grayslake, IL clinic)also started requiring you to wear gowns for physicals but you were given two gowns and were allowed to keep your underwear and socks and shoes on. I haven't been there for a few years so don't know the current policy. |
|
|
|
Post by labrat1 on May 31, 2021 8:59:16 GMT -5
Well now, it would be interesting if anyone who has recently participated in Spaulding or the Grayslake IL clinic can tell if these practices still exist, that is walking the floor barefoot. They may as well have people sit on chairs without any underwear or a gown on.
Also most clinics (so I presume) do not go through the trouble of having the volunteer undress when the physical is really not thorough. It would cost too much to always have complete physicals.
It is more like a basic health evaluation. It is just a check of heart rate, swollen ankles, abdominal tenderness, being able to move your eyes without moving your head , maybe walking a straight line, and looking quickly into your ears and looking into your mouth while you are saying "ahh." My experience is that it is rarely more "intense" than that.
I once tried for a study that required an unusually detailed neurological exam in which I had to walk a straight line, stand up and stay still with both feet together and closing my eyes and stretching my arms to my side and then trying to touch my nose with my index finger ( quite hard to do) and other such tests and since I tend to limp a bit because of arthritis, the doctor took into consideration that I did not walk the straight line very accurately. I did not qualify for the study.
Usually if you can walk the straight line even if you wobble a bit it is not a problem.
Years back I was told at one clinic that the physical requires being undressed wearing a gown and having ears, eyes, and mouth evaluated and also having your sense of smell evaluated but I was told that overall male volunteers have it much worse because they get a very painful and deep prostate exam.
The physical seemed to be carried out as if it was a regular doctor's check-up visit. Unusual for clinical-trial physicals and it seemed to me that it was a common practice in the clinic though sometimes the very intimate exams might not be required.
I only visited that clinic once and I think it eventually closed. I never got to see what it is like in the clinic.
I don't recall anything about walking on the floor barefoot.
That is just not medically safe, not just because of Covid. Also what if someone steps on soing sharp on the floor or gets a splinter?
|
|
|
|
Post by vark on Jun 2, 2021 14:36:15 GMT -5
when i was at spaulding in december, there was no gown stuff. it might have been a study specific thing. they did have a 100% food requirement. on the other hand, i don't have teeth, and i couldn't eat the apple they served at almost every meal, and i didn't get fined for it.
so i would say, go to spaulding one last time, eat what you feel like, you may have your pay docked some, but you will make some money. whether they would ban you for that i don't know. spaulding is one of the few places i can still go, when they have a rare study in my age group.
|
|
|
|
Post by ac on Jun 3, 2021 17:20:45 GMT -5
when i was at spaulding in december, there was no gown stuff. it might have been a study specific thing. they did have a 100% food requirement. on the other hand, i don't have teeth, and i couldn't eat the apple they served at almost every meal, and i didn't get fined for it. so i would say, go to spaulding one last time, eat what you feel like, you may have your pay docked some, but you will make some money. whether they would ban you for that i don't know. spaulding is one of the few places i can still go, when they have a rare study in my age group. March 12th is when the new urine sample policy started. Don't know if it has changed since then. I was thinking I may go back for a big study if the urine sample policy is acceptable.Then I would not eat what I don't want to eat and if I get banned at least I will still have a decent last payday. |
|
