Ideas for Wash Periods, Screening, Pay, VCT and Other Things
Oct 17, 2013 0:51:58 GMT -5
idoitforthepong likes this
Post by smiling4areason on Oct 17, 2013 0:51:58 GMT -5
As I've said before, it's tough to double up studies, especially inpatient studies (which is why the sponsor should pay more of a livable $$ ). Let's not argue the case of whether study stacking happens. It does, in fact according to one well know tracking data base's press release, in the last 18 months it's their service has reviled 1-2 instances on average, per month, nation wide. Considering the volume of participants involved, it's not happening as frequently as we're lead to believe. It's rare that someone is able to double up inpatient studies and on those rare occasions it's only a few days begin shaved off. The rest is just talk. No labrats are consistently going nuts leaving one study and days later dosing in another. It's more prevalent with OPV studies, certainly, but still not the norm. So the solution to data integrity is not VCT, it's not focusing on study stacking, it's better pay, more opportunities to volunteer & longer term inpatient studies.
And consider this, where as several hundred Phase 1 volunteers can be dosed in a few months now with the use of inpatient studies, it will take a years, if we have to hold down both a regular job and volunteer at the the same time to make ends meet. Very few 9-5 jobs are going to say, "yeah, sure take 3 weeks off to go do a study, your job will be waiting when you get back." Not in this market. That's why we are full time volunteers, it's one or the other, there is no doing both on any ongoing basis. We could do weekend studies, sure, and what was once a 3 week inpatient protocol, becomes 3 months of weekend studies with the data integrity almost certainly being compromised by outside environmental factors, as well as volunteer drop out rates increasing, which will lead to further delays, plus the potential for harm to research volunteers as well as less efficient drugs for future pharmaceutical recipients. This trend of studies having OPV Daily for weeks on end, this isn't safe. And who is being served by this? I'd speculate that it's to cut costs, but I don't know. I mean, it would seem to me that slowing the research process, slows time to market + increases the competitions chances of being first to market. That's a formula for getting your *** kicked. That's the kind of CEO decisions that are making companies fail their stock holders expectations so often. And it's also my opinion that when a daily OVP is required, it skates on the bs of not even being scientific, with it's lack of environmental controls. We can't even use soaps with vitamin E at some places (these places are actually more dedicated to data integrity as far I'm concerned), but other places are doing OPV studies where volunteers can run rampant and compromise data at will, with no way to know except in the most extreme situations. Not only that, but when you use the ad-libbed formula I provide later, you'll see that it's hard enough to survive on our low earnings while inpatient, it's absolutely ridicules in an out patient situation with the cost of food and lodging on a daily bases. (about half the volunteers I know have some sort of Pay-As-You-Go living arrangement, it's the only way to make ends meet)
If opportunities to work ue to be reduced, it will no longer be avoidable, the sponsors/clinics will need to increase stipends, or face sporadic enrollment & delayed starts. Face facts, most people with 9-5 jobs, don't have time to do studies. The truth is = 80% of studies are completed through the participation of full time study volunteers. It takes a certain mind set, a certain fortitude and the available time to do this type of work. No 9-5er's will EVER be able to completely fill the need we fill, in a timely fashion. It is through our cooperation with CRU's & our dedication to study completion, that crucial drugs are able to be FAST TRACKED to the sick and often dying people who so desperately need them, saving lives and generating HUGE PROFITS in the process. We're critical to these multi-billion dollar drug companies successful research and time to market goals. If we are further forced into the need for supplemental incomes, the Volunteer pool will ue diminish as good volunteers find jobs they become full time at. It's already hard to fill many studies with good subjects, it will only get worse. People who take life at least half a$$ serious and understand that when you except pay for a job, you have to do the job you excepted as expected, are the same type of people who are finding it harder and harder to make a living Volunteering. When it gets to a point that I can be a clerk at the gas station, come home every day, take a hot bath and get a BJ from my lover, and still net the same income, who'll be left doing studies? It will be the completely incapable, the ones who miss blood draws daily, who are late to everything including dose times, who talk ****, who complain, who are dirty, and who love to hold the clinics hostage saying “**** this, I can just walk out if you don't like it” these are the only types who will be left. Try getting anything done then. So I say again, is saving a nickel really saving anything at all?
We need (I'm not saying deserve, I'm saying NEED) higher stipends.
While $5100 sounds like a huge pay day, it's only huge if you get that monthly, it's nothing when you consider that
start to finish of a study+ wash period+ time to find next available study+ time between screen and admit = 2.5 months up to 4+ months....
We make ****, in reality we net like $500 a week at best to be under 24hr lock down, our bodies violated, no family time, no sex and the real risk of unknown long term side effects, even death (no matter how rare).
To then leave a study and often not be able to maintain a decent standard of living the last few weeks before we work again, it's not right. And I think that the sponsors believe they are doing right by us, $5100 does SOUND like a lot, but that's only because it's viewed as $5100 for say, 27 days, which sounds like a lot. In truth, the commitment is more like 70-120 days and when viewed in this light, we're making more in the range of $40-$75 a day. No 9-5er's would put up with the things we go through for such little pay. We deserve to net $100-$125 per day, but NEED $75-$100 per day minimum during our ENTIRE commitment, just to survive above poverty. And 25% more to survive through an out patient study.
Here it is again...
Time from screen to admit+ Time dosing & attending procedures+ 30 days MINIMUM for wash period = time we are actually committing to each study, time we should be compensated for.
As for VCT. It can harm us by slowing turn around rate and hindering the swift process of research by reducing available study volunteers (in it's current state).
It could help, if gov regulations changed.
If it was used to track a few KEY details, VCT could be a good thing, for everyone involved. It could help reduce the wash out period.
I don't want to advocate unsafe conditions, by any means. I do want to start a discussion of more common sense practices VS the blanket approach currently used. (do we need a 30 day wash after a study? that's a blanket)
For instance, if the 30 day wash period was abolished and replaced with a wash period based solely on dose drug half life (t1/2). And a data base was kept, in which the drug & the last dose was logged and our wash period was based on a per drug basis. We could VERY SAFELY screen after say a 9 Half Life Wash (7 Half Lives= 1/128 drug remaining) and dose after say 18 Half Lives. This would be MORE than safe for volunteers and it would more than maintain data integrity. This would seem to me the perfect solution. It would protect our safety as well as study integrity, decrease time to market for drugs, there by saving more lives, increasing profits and all while keeping the pool of Study Volunteers flush with good candidates. Win/Win/Win
Also, to help, sponsors could offer simple recommendation for diet, exercise and possibly supplement usage guidelines to follow to assist in our bodies regeneration of vital fluids and tissues, as well as speeding detoxification. Maybe have a study specific website & app for this.
Then for example, when we do study for things with say 26.5 hour Half Life, we could re-screen after 10 days and safely dose after 20. With this example alone, in one year, we increase productivity by over 30%. And that's with a 26.5 hour Half Live, is like 2 hours Half Life!! On some thing like that we could be dosed again in less than a week. We could remain free agents, yet improve both our income, our safety, data integrity, all while expediting the research process and only requiring a minimal increase per day in stipends for normal cost of living increases. The living $$ would increase to past levels, the volunteer pool would be flood with quality subjects and everything would run smoother than ever.
But I'm not saying anything new, I'm just saying it.
And consider this, where as several hundred Phase 1 volunteers can be dosed in a few months now with the use of inpatient studies, it will take a years, if we have to hold down both a regular job and volunteer at the the same time to make ends meet. Very few 9-5 jobs are going to say, "yeah, sure take 3 weeks off to go do a study, your job will be waiting when you get back." Not in this market. That's why we are full time volunteers, it's one or the other, there is no doing both on any ongoing basis. We could do weekend studies, sure, and what was once a 3 week inpatient protocol, becomes 3 months of weekend studies with the data integrity almost certainly being compromised by outside environmental factors, as well as volunteer drop out rates increasing, which will lead to further delays, plus the potential for harm to research volunteers as well as less efficient drugs for future pharmaceutical recipients. This trend of studies having OPV Daily for weeks on end, this isn't safe. And who is being served by this? I'd speculate that it's to cut costs, but I don't know. I mean, it would seem to me that slowing the research process, slows time to market + increases the competitions chances of being first to market. That's a formula for getting your *** kicked. That's the kind of CEO decisions that are making companies fail their stock holders expectations so often. And it's also my opinion that when a daily OVP is required, it skates on the bs of not even being scientific, with it's lack of environmental controls. We can't even use soaps with vitamin E at some places (these places are actually more dedicated to data integrity as far I'm concerned), but other places are doing OPV studies where volunteers can run rampant and compromise data at will, with no way to know except in the most extreme situations. Not only that, but when you use the ad-libbed formula I provide later, you'll see that it's hard enough to survive on our low earnings while inpatient, it's absolutely ridicules in an out patient situation with the cost of food and lodging on a daily bases. (about half the volunteers I know have some sort of Pay-As-You-Go living arrangement, it's the only way to make ends meet)
If opportunities to work ue to be reduced, it will no longer be avoidable, the sponsors/clinics will need to increase stipends, or face sporadic enrollment & delayed starts. Face facts, most people with 9-5 jobs, don't have time to do studies. The truth is = 80% of studies are completed through the participation of full time study volunteers. It takes a certain mind set, a certain fortitude and the available time to do this type of work. No 9-5er's will EVER be able to completely fill the need we fill, in a timely fashion. It is through our cooperation with CRU's & our dedication to study completion, that crucial drugs are able to be FAST TRACKED to the sick and often dying people who so desperately need them, saving lives and generating HUGE PROFITS in the process. We're critical to these multi-billion dollar drug companies successful research and time to market goals. If we are further forced into the need for supplemental incomes, the Volunteer pool will ue diminish as good volunteers find jobs they become full time at. It's already hard to fill many studies with good subjects, it will only get worse. People who take life at least half a$$ serious and understand that when you except pay for a job, you have to do the job you excepted as expected, are the same type of people who are finding it harder and harder to make a living Volunteering. When it gets to a point that I can be a clerk at the gas station, come home every day, take a hot bath and get a BJ from my lover, and still net the same income, who'll be left doing studies? It will be the completely incapable, the ones who miss blood draws daily, who are late to everything including dose times, who talk ****, who complain, who are dirty, and who love to hold the clinics hostage saying “**** this, I can just walk out if you don't like it” these are the only types who will be left. Try getting anything done then. So I say again, is saving a nickel really saving anything at all?
We need (I'm not saying deserve, I'm saying NEED) higher stipends.
While $5100 sounds like a huge pay day, it's only huge if you get that monthly, it's nothing when you consider that
start to finish of a study+ wash period+ time to find next available study+ time between screen and admit = 2.5 months up to 4+ months....
We make ****, in reality we net like $500 a week at best to be under 24hr lock down, our bodies violated, no family time, no sex and the real risk of unknown long term side effects, even death (no matter how rare).
To then leave a study and often not be able to maintain a decent standard of living the last few weeks before we work again, it's not right. And I think that the sponsors believe they are doing right by us, $5100 does SOUND like a lot, but that's only because it's viewed as $5100 for say, 27 days, which sounds like a lot. In truth, the commitment is more like 70-120 days and when viewed in this light, we're making more in the range of $40-$75 a day. No 9-5er's would put up with the things we go through for such little pay. We deserve to net $100-$125 per day, but NEED $75-$100 per day minimum during our ENTIRE commitment, just to survive above poverty. And 25% more to survive through an out patient study.
Here it is again...
Time from screen to admit+ Time dosing & attending procedures+ 30 days MINIMUM for wash period = time we are actually committing to each study, time we should be compensated for.
As for VCT. It can harm us by slowing turn around rate and hindering the swift process of research by reducing available study volunteers (in it's current state).
It could help, if gov regulations changed.
If it was used to track a few KEY details, VCT could be a good thing, for everyone involved. It could help reduce the wash out period.
I don't want to advocate unsafe conditions, by any means. I do want to start a discussion of more common sense practices VS the blanket approach currently used. (do we need a 30 day wash after a study? that's a blanket)
For instance, if the 30 day wash period was abolished and replaced with a wash period based solely on dose drug half life (t1/2). And a data base was kept, in which the drug & the last dose was logged and our wash period was based on a per drug basis. We could VERY SAFELY screen after say a 9 Half Life Wash (7 Half Lives= 1/128 drug remaining) and dose after say 18 Half Lives. This would be MORE than safe for volunteers and it would more than maintain data integrity. This would seem to me the perfect solution. It would protect our safety as well as study integrity, decrease time to market for drugs, there by saving more lives, increasing profits and all while keeping the pool of Study Volunteers flush with good candidates. Win/Win/Win
Also, to help, sponsors could offer simple recommendation for diet, exercise and possibly supplement usage guidelines to follow to assist in our bodies regeneration of vital fluids and tissues, as well as speeding detoxification. Maybe have a study specific website & app for this.
Then for example, when we do study for things with say 26.5 hour Half Life, we could re-screen after 10 days and safely dose after 20. With this example alone, in one year, we increase productivity by over 30%. And that's with a 26.5 hour Half Live, is like 2 hours Half Life!! On some thing like that we could be dosed again in less than a week. We could remain free agents, yet improve both our income, our safety, data integrity, all while expediting the research process and only requiring a minimal increase per day in stipends for normal cost of living increases. The living $$ would increase to past levels, the volunteer pool would be flood with quality subjects and everything would run smoother than ever.
But I'm not saying anything new, I'm just saying it.
