» Knowing a little about statistics, I vaguely remember that the lowest
» possible sample population before one can gain a rough but somewhat
» reliable statistical significance is n=30.
Many methods have been developed throughout the years that allow for smaller sample sizes than n=30. In any experiment such as this, it is always difficult to keep a balance between having adequate sample sizes (thus reducing the margin of error) and wasting time and money. Since ICX has limited funding and the regulations for cell therapy allow for very small trials (due to the history of safety compared to drug trials), it probably makes sense to operate at near the minimum amount of trialists needed using small sample statistical techniques.
» » Knowing a little about statistics, I vaguely remember that the lowest
» » possible sample population before one can gain a rough but somewhat
» » reliable statistical significance is n=30.
»
» Many methods have been developed throughout the years that allow for
» smaller sample sizes than n=30. In any experiment such as this, it is
» always difficult to keep a balance between having adequate sample sizes
» (thus reducing the margin of error) and wasting time and money. Since ICX
» has limited funding and the regulations for cell therapy allow for very
» small trials (due to the history of safety compared to drug trials), it
» probably makes sense to operate at near the minimum amount of trialists
» needed using small sample statistical techniques.
When they try on 1000 people in phase III for drug, it’s not for safety because safety has been done in particularly phase I and a bit in phase II. Phase III is mostly for final proof…
Maybe its me…but when the trials to possibly cure baldness… a “disease” that has been around for thousands of years (as many have put it)…an advancement that would be huge to many people…its just doesnt make sense to use fewer trialists that you might meet at a bar after work…I mean six or seven people ??? No…Its not necessary to use “40,000 or the whole world”, as one poster (thankfully) pointed out to me (good thing I am not running the trails…otherwise EVERYBODY in the world…even the ones who arent going bald…would be in the trails…babies would get HM before they even grew their own hair)ANYWAYS…
It just doesnt make sense to use six or seven…I dont think 30 or maybe 50 people would be an unreasonable number…Plus as Cassinova stated…why does ICX state they are going to use cohorts of 20…and then use six ??? Guess I would just like to see a little more “aggressive” approach to this research
» » Knowing a little about statistics, I vaguely remember that the lowest
» » possible sample population before one can gain a rough but somewhat
» » reliable statistical significance is n=30.
»
» Many methods have been developed throughout the years that allow for
» smaller sample sizes than n=30. In any experiment such as this, it is
» always difficult to keep a balance between having adequate sample sizes
» (thus reducing the margin of error) and wasting time and money. Since ICX
» has limited funding and the regulations for cell therapy allow for very
» small trials (due to the history of safety compared to drug trials), it
» probably makes sense to operate at near the minimum amount of trialists
» needed using small sample statistical techniques.
Also, I’d like to point out that the necessary sample size depends on the type of conclusion you wish to draw and on your experimental results.
To take an extreme example, say my sample size is only one person. If I have positive results on this one person, then I can conclude with 100% certainty that my product works on some part of the population. So for the result I got and the conclusion I drew, a sample of one was sufficient.
On the other hand, if I tested this one person and the result was negative, I’ll need to do some further testing to prove that my product works on some part of the population. However, I proved with 100% certainty that it doesn’t work on all people.
So until we know both what ICX needs to prove and what their results were, we can’t really tell whether their sample sizes are sufficient or not.
» » » Knowing a little about statistics, I vaguely remember that the lowest
» » » possible sample population before one can gain a rough but somewhat
» » » reliable statistical significance is n=30.
» »
» » Many methods have been developed throughout the years that allow for
» » smaller sample sizes than n=30. In any experiment such as this, it is
» » always difficult to keep a balance between having adequate sample sizes
» » (thus reducing the margin of error) and wasting time and money. Since
» ICX
» » has limited funding and the regulations for cell therapy allow for very
» » small trials (due to the history of safety compared to drug trials), it
» » probably makes sense to operate at near the minimum amount of trialists
» » needed using small sample statistical techniques.
»
» When they try on 1000 people in phase III for drug, it’s not for safety
» because safety has been done in particularly phase I and a bit in phase
» II. Phase III is mostly for final proof…
Okay, here’s how ICX-TRC is different than those drugs they test on a 1000 people. The key here is the placebo effect.
Say you are testing a cancer drug. In any given population with cancer, some will get better and some will get worse even without the drug you’re testing. So how are you going to know that it’s your drug that made a positive impact, and people didn’t get better just by chance? Also, many drugs have a relatively small impact. Suppose a drug only helps 10% of the people. In such a case it’s easy to see how a sample of 10 people would be nearly useless given that some people would get better anyway without the drug. So we’d need a much larger sample here. This is why you get studies with thousands of people.
But for ICX-TRC, there is no bloody way in hell (this post is rated R), a hair would grow at the injection site for any other reason but the TRC injection itself. So the placebo effect is pretty much non-existent, and therefore ICX can get away with small samples and still prove efficacy.
» Even if there’s a 100% response rate from these 6 and even the next 6 to
» 10 – that’s still too few to say with any certainty.
Say what with any certainty? We know with 100% complete certainty that TRC works on some people. Is that certain enough or not?
» Maybe its me…but when the trials to possibly cure baldness… a
» “disease” that has been around for thousands of years (as many have put
» it)…an advancement that would be huge to many people…its just doesnt
» make sense to use fewer trialists that you might meet at a bar after
» work…I mean six or seven people ??? No…Its not necessary to use
» “40,000 or the whole world”, as one poster (thankfully) pointed out to me
» (good thing I am not running the trails…otherwise EVERYBODY in the
» world…even the ones who arent going bald…would be in the
» trails…babies would get HM before they even grew their own
» hair)ANYWAYS…
»
» It just doesnt make sense to use six or seven…I dont think 30 or
» maybe 50 people would be an unreasonable number…Plus as Cassinova
» stated…why does ICX state they are going to use cohorts of 20…and
» then use six ??? Guess I would just like to see a little more “aggressive”
» approach to this research
i’d like to see like 30 people tested also, but maybe ICX couldn’t afford to test anymore then what they’ve already got. who knows.
so let me ask you this, if all the trialist that they are testing (6, 12, whatever) came out with full heads of hair would you be skeptical because they didn’t test more people?
» i’d like to see like 30 people tested also, but maybe ICX couldn’t afford
» to test anymore then what they’ve already got. who knows.
»
» so let me ask you this, if all the trialist that they are testing (6, 12,
» whatever) came out with full heads of hair would you be skeptical because
» they didn’t test more people?
No, I wouldnt…but right now…more trialists would give them more opportunity to test different protocols, ect…I just think that the limited number is just going to slow down progress at this point…
» So until we know both what ICX needs to prove and what their results were,
» we can’t really tell whether their sample sizes are sufficient or not.
That’s true. But my point is that statistical analysis using smaller sample sizes than n=30 is a common thing. Mathematical techniques have been developed to allow for this. This in conjunction with the fact that cell therapy has a good safety record is how ICX is able to get away with using much smaller sample sizes than the typical drug trial. Of course, the regulations in Britian are a little different than in the states, but the FDA has a complete different set of regulations for cell therapy than they do drug trials. In cell therapy trials, you are allowed to use smaller sample sizes. By contrast, in drug trials you are required to use large sample sizes. Thus, it is not out of character for a small startup cell therapy company with limited funding to use sample sizes near the minimum required by regulating bodies to establish safety and efficacy of the product. Especially given the fact that they are developing multiple products simultaneously, which can get very expensive in a hurry.
In short, if ICX wants to stay alive, they are smart to be frugal and conserve resources at least until they establish a regular cash flow that results from product sales. IMO, their main focus right now is trying to get something on the market, even if the sales are only mediocre. The face lift in a syringe pretty much satisfies this criteria.
» Maybe its me…but when the trials to possibly cure baldness… a
» “disease” that has been around for thousands of years (as many have put
» it)…an advancement that would be huge to many people…its just doesnt
» make sense to use fewer trialists that you might meet at a bar after
» work…I mean six or seven people ??? No…Its not necessary to use
» “40,000 or the whole world”, as one poster (thankfully) pointed out to me
» (good thing I am not running the trails…otherwise EVERYBODY in the
» world…even the ones who arent going bald…would be in the
» trails…babies would get HM before they even grew their own
» hair)ANYWAYS…
»
» It just doesnt make sense to use six or seven…I dont think 30 or
» maybe 50 people would be an unreasonable number…Plus as Cassinova
» stated…why does ICX state they are going to use cohorts of 20…and
» then use six ??? Guess I would just like to see a little more “aggressive”
» approach to this research
I have to disagree. I believe it does make sense to use fewer trialists when you take into account that ICX can figure out with 6 or 7 people whether they need to make an adjustment to their protocol. I would agree with you if it weren’t for the cost of running trials with 30 or 50 people. If you figure the cost of each trialist to be $10,000.00, then 6 people only costs 60 grand, but 50 people costs a half million dollars. Now ask yourself what happens if that half million dollars shows that the protocol needs a definitive adjustment? Well, you just blew $440,000.00 because you could have figured out that same result for $60k. Now you have to do a follow up trial to see if your protocol adjustment works. But you have blown all of your money on the first trial, so you have to take another half million away from your other product development funds in order to do the follow up HM trial. What happens if the result of this trial is that the protocol still needs an adjustment? In short, this is a good way to bankrupt a company.
Now you might be thinking that smaller trials are going to slow down the development of HM. This may or may not be the case. The goal here is to travel as light as possible until enough data is acquired to justify the expense of larger trials (i.e. phase III). This methodology might actually speed up the process because it is so much resource less intensive.
I agree with you that ultimately we would like more data from these trials. But I do not believe it is financially realistic to do this so early on. ICX is trying to establish dosage and also tweaking the protocol in order to get marketable percentages. They do not need to see perfection here; they just need a marketable product that brings in positive cash flow.
Fewer trialists really only means the margin of error is going to be greater. And this in no way represents the deal breaker. The real deal breaker is if this company runs out of money before they can establish a positive cashflow. (but that is of course just my opinion)
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