The Cure In a Clinical Trial?
One of the reasons some people consider participating in a clinical trial when they normally wouldn't is because they have a condition that has not responded well to existing treatments. Frustrated with the therapies they have tried or desperate as their condition worsens, the prospect of a cure becomes particularly encouraging. This prospect leads some to seriously consider enrolling in a clinical trial of a new therapy, even when they would not normally take the risks involved because the only way to get the experimental therapy is to participate in the clinical trial.
What risks? Every new therapy carries with it two types of risks: those that are anticipated and those that are not. If the therapy (let's say it's a drug) involves a compound that has been used in people or animals before, for other purposes, then many of the risks (side effects) are known or can at least be anticipated.
If the drug is new, then its effects on people are not yet known, so most of the risks are unknown. Just because a risk is known, doesn't mean it's insignificant. All it means is that it is somewhat more feasible to weigh the risks of taking the drug against the possibility that the drug may ease, or even cure, the condition.
The most uncertain situation involves a truly new compound. In such cases, there is some reason to believe that the compound may help, otherwise it would not make sense to conduct or enroll in the research as a therapy. But the certainty of the compound's effectiveness is very low. At the same time, the safety of the compound is also uncertain. The participant doesn't know whether the therapy will work and doesn't know how much damage the therapy may do.
Is it ethical for the medical community to make a new treatment available only to clinical trial participants?
By definition, a new treatment has not yet been tested, so its safety and effectiveness are unknown. It would not be ethical to market an untested treatment. In addition, it is particularly important to measure the effects of the experimental treatment on individual patients as well as the patient population at large in order to make the case for or against the use of the treatment for a particular condition. And the only way to do that is within the carefully-controlled conditions of a clinical trial.
If someone's condition is bad enough, if their prospects are dim and their symptoms are intolerable, then taking the virtually unknown risks of trying a treatment that may or may not show any effectiveness may be a reasonable course of action. But assuming such risks for unknown benefits is probably not wise for someone who has other - any other - medical options.
-Joe
Related Topics: Experimental Drug May Fight Pancreatic Cancer, Prostate Cancer Choice a Coin Toss?
What risks? Every new therapy carries with it two types of risks: those that are anticipated and those that are not. If the therapy (let's say it's a drug) involves a compound that has been used in people or animals before, for other purposes, then many of the risks (side effects) are known or can at least be anticipated.
If the drug is new, then its effects on people are not yet known, so most of the risks are unknown. Just because a risk is known, doesn't mean it's insignificant. All it means is that it is somewhat more feasible to weigh the risks of taking the drug against the possibility that the drug may ease, or even cure, the condition.
The most uncertain situation involves a truly new compound. In such cases, there is some reason to believe that the compound may help, otherwise it would not make sense to conduct or enroll in the research as a therapy. But the certainty of the compound's effectiveness is very low. At the same time, the safety of the compound is also uncertain. The participant doesn't know whether the therapy will work and doesn't know how much damage the therapy may do.
Is it ethical for the medical community to make a new treatment available only to clinical trial participants?
By definition, a new treatment has not yet been tested, so its safety and effectiveness are unknown. It would not be ethical to market an untested treatment. In addition, it is particularly important to measure the effects of the experimental treatment on individual patients as well as the patient population at large in order to make the case for or against the use of the treatment for a particular condition. And the only way to do that is within the carefully-controlled conditions of a clinical trial.
If someone's condition is bad enough, if their prospects are dim and their symptoms are intolerable, then taking the virtually unknown risks of trying a treatment that may or may not show any effectiveness may be a reasonable course of action. But assuming such risks for unknown benefits is probably not wise for someone who has other - any other - medical options.
-Joe
Related Topics: Experimental Drug May Fight Pancreatic Cancer, Prostate Cancer Choice a Coin Toss?
4 Comments:
As a clinical trial participant, it's interesting to me how you ended your article. It almost makes me feel desparate. :-)
Have you actually spoken to any particpants? My intentions in joining were merely to have all aspects of my condition more regularly addressed by a medical doctor. I'm not complaining about any lack of previous treatment, simply assuring that anything that comes up will be investigated thoroughly and in a more timely manner. So far, so good...
I'm glad to hear your experience has been good so far. I was primarily referring to clinical trials exposing participants to significant risks and where alternative treatments exist. You make a good point about receiving closer observation and timely care when in a clinical trial.
According to me, whenever a clinical trial is being tested on humans, the protocol is set up in such a way that adequate care is taken of the patient participating. A simple leg pain which may be a normal phenomenon for the participant, must be a big deal for the Clinical trial conducting person. Its with clinical trials can we bring in better treatment for the rest of the world.
Also, the trial procedures are explained completely and its the patient's interest to take part in the trial.
The article is misleading in stating that the effectiveness and risks of the new drug are virtually unknown. As a drug proceeds through the many different stages of preclinical and clinical testing, knowledge is constantly increasing. Obviously, in later phases such Phase III clinical trials (the last stage before FDA approval), there is a lot more information available than in earlier stages.
The article seems to imply, inaccurately, that while drugs are still in trials everything is "virtually unknown", then, suddenly, when drugs are on the market, lots of information is available.
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