4 ms·

Patient compensation is intentionally limited to prevent economic incentives from interfering with informed consent; pay people too much and they may participat

Patient compensation is intentionally limited to prevent economic incentives from interfering with informed consent; pay people too much and they may participate in research that they would have passed on. Also, speaking from experience, patient compensation is a very small amount (5% or less) of overall cost. The vast majority goes to clinical staff costs, room costs, hospital overhead, labs etc.

pfdietz 4y ago
That's not a vaccine trial though, right? I'm figuring those need more participants and have more retention problems, as well as less risk of informed consent problems.
- ebiester 4y ago
  I mean, the CONFIRM trial (https://www.research.va.gov/currents/1117-Largest-ever-VA-clinical-trial.cfm https://www.research.va.gov/currents/1117-Largest-ever-VA-cl...) had 50,000 patients. (That's not a pharmaceutical sponsor-led clinical trial, but it is a clinical trial.) But yes, the largest phase 3 trials ever are generally vaccines. https://www.evaluate.com/vantage/articles/news/snippets/its-official-covid-19-vaccine-trials-rank-among-largest https://www.evaluate.com/vantage/articles/news/snippets/its-...
boole1854 4y ago
> Patient compensation is intentionally limited to prevent economic incentives from interfering with informed consent; pay people too much and they may participate in research that they would have passed on. I'm not sure I understand the logic here. How does agreement suddenly become less informed or less consensual because the participant gets paid more? Sure, if they get paid more, they might be willing to accept more risk or do something more unpleasant. But that seems fair, not immoral. Why would it be more fair to say "yes, perhaps this trial is risky, but we only want participants who don't demand to be compensated much for the risk they take"? If anything, maybe that approach leads to less informed consent by filtering out the people who actually understand the risk and would have only agreed to participant in exchange for more compensation! Should we also be morally offended any time an employer raises wages in order to attract more workers?
- knodi123 4y ago
  > How does agreement suddenly become less informed or less consensual because the participant gets paid more Why shouldn't college professors sleep with their students? How does the relationship become less informed or less consensual? The answer is power. Money is power, and too large of a power imbalance corrupts a relationship. Money is pressure, and too much pressure is coercive.
  - s1artibartfast 4y ago
    I think it's still a fair question. The money is intended to be an incentive. If the trial is ethical and has a positive risk benefit ratio, there is no harm from coercion.
    - knodi123 4y ago
      Okay, but what if a person sincerely does not want to participate in a medical trial? But then when he sees the dollar figure, he thinks "well, shit, I hate doing this, but I can't afford to turn that much money down." Same reason we don't allow the purchase of kidneys, and the same reason we think it's unethical for a millionaire with a tophat and a monocle to offer two homeless guys a wad of money to the winner if they fight each other. Sure, it's an adult making a decision of their own free will- but it's obviously unethical.
      - pfdietz 4y ago
        This seems either too much or not enough. Is it ok to pay more for risky or injurious jobs? If so, why not for medical trials? Simply working in a job where you have to kneel or lift your arms above your head all day leads to long term injury.
  - JamesianP 4y ago
    Professors historically were prohibited from relationships with students because it creates the appearance (and high likelihood) of favoritism. And it probably pisses parents off a lot because the age difference seems creepy. "Power" is a relatively new argument. These days the student has the power to utterly destroy the professor. The professor has at best the charismatic "power" equivalent to any number of smooth pickup artists occupying college dorms, of getting a temporary good time.
pinky1417 4y ago
That's true. Good Clinical Practice guidelines say that Institutional Review Boards must evaluate compensation is not too high otherwise it constitutes "undue influence". ...but I think that's a terrible idea. I understand that, to come up with a far-fetched example, high compensation could result in some weird edge cases where, for example, a Phase I trial with healthy volunteers and a non-preventive drug candidate (e.g. an antibiotic rather than a COVID vaccine), but you're confident that drug is going to kill 99% of the volunteers so you offer $10 million to each volunteer. A totally informed volunteer might view this as something akin to a life insurance policy that pays out to the family even upon suicide. I don't personally see an ethical problem with that so long as volunteers are really well-informed, but I could see how others and the law would be uncomfortable with the ethics of such a situation. But aside from that far-fetched situation, it seems harmful to limit compensation... especially if it's true that patient compensation is a small part of overall cost. Perhaps if every trial doubled compensation to 10% of today's overall costs, absolute overall costs would decrease because less effort has to go into patient recruitment. I do see one real-world issue with high compensation, but it has nothing to do with ethics. It has to do with statistical interpretation. If you start dangling too much money to participate in a trial, you may change the kind of people who participate in the trial. These individuals might not be representative of the actual users of the drug. The problem is similar to running a drug trial in the US versus Japan. The US has a pretty diverse population with respect to genetics. Japan, in contrast, is almost entirely ethnic Japanese. If you were to somehow succeed in using Japanese trial data to market an acne cream in the US, the same drug that cleared up Japanese faces might result in Venezuelans having their noses fall off! However, I'm cautiously optimistic that higher compensation could make trials more representative. In my mind, I could see how African-Americans, who tend to participate in trials at a lower rate than their Caucasian fellow humans, would, if only for the shameful history of the Tuskegee Syphilis Study, require greater compensation to take the risk of participating in a trial.
- idealmedtech 4y ago
  As you said, at the end of the day it's an ethical guideline that must be upheld, more than something based in economics. We do compensate participants as well as we're allowed within these guidelines! I agree with your points, but compensation must be approved by the independent institutional review board, who is accountable to national ethical review boards and thus acts very conservatively.

pfdietz 4y ago

That's not a vaccine trial though, right? I'm figuring those need more participants and have more retention problems, as well as less risk of informed consent problems.

ebiester 4y ago
I mean, the CONFIRM trial (https://www.research.va.gov/currents/1117-Largest-ever-VA-clinical-trial.cfm https://www.research.va.gov/currents/1117-Largest-ever-VA-cl...) had 50,000 patients. (That's not a pharmaceutical sponsor-led clinical trial, but it is a clinical trial.) But yes, the largest phase 3 trials ever are generally vaccines. https://www.evaluate.com/vantage/articles/news/snippets/its-official-covid-19-vaccine-trials-rank-among-largest https://www.evaluate.com/vantage/articles/news/snippets/its-...

boole1854 4y ago

> Patient compensation is intentionally limited to prevent economic incentives from interfering with informed consent; pay people too much and they may participate in research that they would have passed on. I'm not sure I understand the logic here. How does agreement suddenly become less informed or less consensual because the participant gets paid more? Sure, if they get paid more, they might be willing to accept more risk or do something more unpleasant. But that seems fair, not immoral. Why would it be more fair to say "yes, perhaps this trial is risky, but we only want participants who don't demand to be compensated much for the risk they take"? If anything, maybe that approach leads to less informed consent by filtering out the people who actually understand the risk and would have only agreed to participant in exchange for more compensation! Should we also be morally offended any time an employer raises wages in order to attract more workers?

knodi123 4y ago
> How does agreement suddenly become less informed or less consensual because the participant gets paid more Why shouldn't college professors sleep with their students? How does the relationship become less informed or less consensual? The answer is power. Money is power, and too large of a power imbalance corrupts a relationship. Money is pressure, and too much pressure is coercive.
- s1artibartfast 4y ago
  I think it's still a fair question. The money is intended to be an incentive. If the trial is ethical and has a positive risk benefit ratio, there is no harm from coercion.
  - knodi123 4y ago
    Okay, but what if a person sincerely does not want to participate in a medical trial? But then when he sees the dollar figure, he thinks "well, shit, I hate doing this, but I can't afford to turn that much money down." Same reason we don't allow the purchase of kidneys, and the same reason we think it's unethical for a millionaire with a tophat and a monocle to offer two homeless guys a wad of money to the winner if they fight each other. Sure, it's an adult making a decision of their own free will- but it's obviously unethical.
    - pfdietz 4y ago
      This seems either too much or not enough. Is it ok to pay more for risky or injurious jobs? If so, why not for medical trials? Simply working in a job where you have to kneel or lift your arms above your head all day leads to long term injury.
- JamesianP 4y ago
  Professors historically were prohibited from relationships with students because it creates the appearance (and high likelihood) of favoritism. And it probably pisses parents off a lot because the age difference seems creepy. "Power" is a relatively new argument. These days the student has the power to utterly destroy the professor. The professor has at best the charismatic "power" equivalent to any number of smooth pickup artists occupying college dorms, of getting a temporary good time.

pinky1417 4y ago

That's true. Good Clinical Practice guidelines say that Institutional Review Boards must evaluate compensation is not too high otherwise it constitutes "undue influence". ...but I think that's a terrible idea. I understand that, to come up with a far-fetched example, high compensation could result in some weird edge cases where, for example, a Phase I trial with healthy volunteers and a non-preventive drug candidate (e.g. an antibiotic rather than a COVID vaccine), but you're confident that drug is going to kill 99% of the volunteers so you offer $10 million to each volunteer. A totally informed volunteer might view this as something akin to a life insurance policy that pays out to the family even upon suicide. I don't personally see an ethical problem with that so long as volunteers are really well-informed, but I could see how others and the law would be uncomfortable with the ethics of such a situation. But aside from that far-fetched situation, it seems harmful to limit compensation... especially if it's true that patient compensation is a small part of overall cost. Perhaps if every trial doubled compensation to 10% of today's overall costs, absolute overall costs would decrease because less effort has to go into patient recruitment. I do see one real-world issue with high compensation, but it has nothing to do with ethics. It has to do with statistical interpretation. If you start dangling too much money to participate in a trial, you may change the kind of people who participate in the trial. These individuals might not be representative of the actual users of the drug. The problem is similar to running a drug trial in the US versus Japan. The US has a pretty diverse population with respect to genetics. Japan, in contrast, is almost entirely ethnic Japanese. If you were to somehow succeed in using Japanese trial data to market an acne cream in the US, the same drug that cleared up Japanese faces might result in Venezuelans having their noses fall off! However, I'm cautiously optimistic that higher compensation could make trials more representative. In my mind, I could see how African-Americans, who tend to participate in trials at a lower rate than their Caucasian fellow humans, would, if only for the shameful history of the Tuskegee Syphilis Study, require greater compensation to take the risk of participating in a trial.

idealmedtech 4y ago
As you said, at the end of the day it's an ethical guideline that must be upheld, more than something based in economics. We do compensate participants as well as we're allowed within these guidelines! I agree with your points, but compensation must be approved by the independent institutional review board, who is accountable to national ethical review boards and thus acts very conservatively.