Clinical trial in children

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MichaelXY
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Clinical trial in children

Post by MichaelXY » Thu Jul 09, 2009 8:52 am

How about a thread where we discuss the ethics of treating underage children in clinical trials? Are the childrens voices and concerns valid, or do they have no voice at all.

To young to consent, so how can they make a proper choice? Is it ethical to put these children in danger for science?

Is it ethical to allow a child to make such a choice?

Much of clinical trials will not allow children under 18 into a study and this makes sense as one should be of consenting age; however this thinking poses a problem. Doses of a drug are not always based on weight or size, rather metabolism. Doses for adults do not always scale down to children in a 1 for 1 method.

This creates a big problem for children as they now receive weight based doses of medication yet this alone may be improper as other processes are ignored. How then do we approach trials for children?

I have thought about this for awhile and find myself at a perplexing quandary.

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Re: Clinical trial in children

Post by mcar » Sat Jul 11, 2009 10:46 am

There are always laws protecting the welfare of children and they are not just always supposed to be subjected to clinical trials.:wink:
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Post by AstusAleator » Sun Jul 12, 2009 6:06 am

Certain medications such as innoculations are vital to have administered during youth. If such a medication is being tested, I see no other way to perform a clinical trial than on children... It would be good to have not only the parents consent, but the child's as well.

I haven't heard of any children's medications having problems with over dosage - which would be a potential result of scaling according to mass. Maybe they take metabolism into account as well.

If a drug is not specifically meant for children, then I don't think they should be put at risk. They are not of the age of consent. Furthermore, who gets paid for the trials? You know the kid's probably not getting the money, and if they are, that's child labor isn't it?
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Re:

Post by MichaelXY » Sun Jul 12, 2009 9:40 am

AstusAleator wrote:Certain medications such as innoculations are vital to have administered during youth. If such a medication is being tested, I see no other way to perform a clinical trial than on children... It would be good to have not only the parents consent, but the child's as well.

I haven't heard of any children's medications having problems with over dosage - which would be a potential result of scaling according to mass. Maybe they take metabolism into account as well.

If a drug is not specifically meant for children, then I don't think they should be put at risk. They are not of the age of consent. Furthermore, who gets paid for the trials? You know the kid's probably not getting the money, and if they are, that's child labor isn't it?


There are many things involved here. Many diseases are not age specific, such as cancer. In the case of cancer, chemotherapy is often used. To date children have not been involved in clinical trials as they are not of the age of consent. This has led to weight based dosages for children. The problem here is that this thinking can either be overly toxic, or the efficacy is lacking.

By law, and the declaration of Helsinki, children are not able to make a sound choice in treatment. This is left to doctors and parents, but often the parent is lacking good judgment to make an educated decision, and this raises the question of ethics; should the doctor influence the lesser educated parent. At this point an ethics boundary is crossed.

All the while, the people conducting the trials realize these shortcomings as mentioned above, yet their hands are tied. Surely the question of proper dosage for children could be determined, but this would require violating a child’s rights.

So now the quandary, conduct trials only on consenting adults, or do we simply put children at risk based on the needs of the many?

Do you see the dilemma?

My point is, children deserve the same treatment as their adult counterparts, but to do so rasises an ethical puzzle.

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Post by AstusAleator » Mon Jul 13, 2009 12:01 am

Do you see there being a need for minors participating in clinical trials? I know at least one person that had cancer when she was young - and I'm pretty sure she's just glad she's alive.

If we saw a rash of overdosage or unnaceptable levels of side-effects then I'd say a red flag needs to be raised. I haven't researched it, so I don't know if this is going on or not. It seems to me that we have very accurate ways of determining a person's metabolic rate - so the smarties at the pharmaceutical companies should be able to figure out how to scale their medications not only according to mass but metabolism as well...
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Re: Clinical trial in children

Post by MichaelXY » Mon Jul 13, 2009 6:39 am

It seems to me that we have very accurate ways of determining a person's metabolic rate - so the smarties at the pharmaceutical companies should be able to figure out how to scale their medications not only according to mass but metabolism as well...


In an ideal world perhaps, but unfortunately children and their bodies are very diverse in the growth process. For some children their kidneys and livers develop faster than others so there is no easy math equation or computer model that can simulate a child's response to a drug. Weight and height alone are inadequate in determination of the expected results.

Clearly this issue must be addressed, but at the same time how do we maintain our model of ethics.

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Re: Clinical trial in children

Post by MichaelXY » Wed Jul 15, 2009 7:03 am

The main reason I was asking the above questions was that I was trying to prepare myself for a job interview that I had today. The position was for a web page writer in a non profit organization aimed at treating children with cancer. The co-founder of the organization thinks I will do well in translating her technical papers into a more readable paper that the general public can understand, so that is my job.

After the interview I discovered that my thinking was way off base. This project intends to develop customized therapies based on a child's DNA and enzyme activity. This was all new to me, but I was fascinated to say the least.

BTW, I did get the job, it is a non paying job, but I feel this may open some doors for me later on down the line, so I accepted the challenge.

If your interested in what sort of work is developing in cancer research, check out this link on Molecular diagnostics. Cool stuff.

http://www.cancer.gov/cancertopics/unde ... iagnostics

I decided not to post the name of the institute as this may not be appropriate.

Wish me luck...
Last edited by MichaelXY on Wed Jul 15, 2009 9:48 am, edited 2 times in total.

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Re:

Post by MichaelXY » Wed Jul 15, 2009 7:21 am

AstusAleator wrote:Do you see there being a need for minors participating in clinical trials? I know at least one person that had cancer when she was young - and I'm pretty sure she's just glad she's alive.

If we saw a rash of over dosage or unacceptable levels of side-effects then I'd say a red flag needs to be raised. I haven't researched it, so I don't know if this is going on or not. It seems to me that we have very accurate ways of determining a person's metabolic rate - so the smarties at the pharmaceutical companies should be able to figure out how to scale their medications not only according to mass but metabolism as well...


Some other things I learned today. Cancer therapies for adults often do not work for children, and the therapies used for children often lead to debilitating side affects later on in life.

There is only a 1% of the child population that develops cancer, as cancer is more of an adult disease. Due to this fact most pharmaceutic companies will not take on research for childhood cancer as research and conducting clinical trial cost about 1 billion bucks.. This leaves any research done as a orphan project, which is still not an incentive to tackle this small population.

This institute has a clever plan to overcome this cost issue, but I apologize I can not divulge this info.

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Post by AstusAleator » Fri Jul 17, 2009 1:42 am

Sounds like a cool job. Sucks it doesn't pay, but it really does sound like you'll have some great networking opportunities and get your foot in lots of doors. Good luck!
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Re: Clinical trial in children

Post by stephenmorphey » Fri Aug 21, 2009 6:58 am

Yes, there are laws against the clinical trials of underage children. But none are seen to because the children are unable to consent and their voices go unheard.
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Post by 2009queenb » Mon Aug 24, 2009 7:48 pm

I honestly don't see the problem with it. They are also human beings. As are humans. Yes children are innocent, but if you think about it on a wider lens, why can't children participate. If they agree (I believe in personal choice over consenting choice). Kids are people too, they deserve rights. And if they wanted to participate knowing the risks, who are we to take away their right as a human being and not let them? Because they are children? And? They will be put at risk? Well so will adults. I love kids and protect them but this one I'm open about.
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Post by canalon » Tue Aug 25, 2009 1:59 am

The problem is that of informed consent. How well do you think a 3 year old or an infant is going to understand what a medical procedure consist of and agree to its benefits after weighing out the risks. Honestly many (most?) adults are completely unable to actually do that!

One solution is to use the consent of the parents/guardian of the kid, as it is usually done for many other aspects of life. But then again, the informed consent in the strong form used here is not always guaranteed. And we know that some parents are ready to do thingd that are not necessarily in the best interest of their children in some circumstances. However this seem to be the only solution anyway. So Hope for a good ethics commitee to make sure that risks are weighted beforehand and that the research is still worth (in terms of medical benefits, not monetarily) being done.
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