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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?
