Can We Dump Randomized Clinical Trials?

If a boxer knocked out 12 of 13 opponents, would you bet on him winning most of the next 10 bouts? Probably you would. Certainly, nobody would think you were crazy or crooked.

But that’s bad science!

Specifically, that’s not a big enough series of cases to justify confidence that he could keep winning.

We have a lot of problems with defining science, even when we are well-meaning and intelligent (not in the pay of some drug cartel). The answers you get depend, largely, on the questions you ask (like in real life!)

But one of the difficulties dogging mainstream science is randomized controlled double-blind trials. OK, I don’t need to go into the definition of double-blind, etc. Let’s focus on the word “randomized”.

It means what is says. Somewhere in the study a computer spits out a series of random numbers, saying who gets what treatment, in what order. It’s supposed to remove chance and bias.

But if you’ve ever tossed a coin and got 8 heads in a row, you’ll know that you can’t totally rule out the surprises of chance. The only way to eliminate it from your calculations is to do very large numbers of examples.

We all know that if you go on and on tossing a coin, it will eventually come out roughly equal: as many tails as heads. 8 out of 10 heads was just a lucky run. It gave a false impression. But eventually you would have, say, 2963 heads and 2922 tails, or roughly equal.

The trouble is, with science investigations, you can’t always assemble enough people to make a statistically significant case. You might need thousands of cases, yet you can only find a few hundred volunteers. What to do?

Common sense says go ahead and make the best of it you can; at least you’ll get some sense of a result. You might even get lucky and find the evidence points overwhelmingly in one direction (but remember the 8 heads out of 10 coin tosses warning!) Your results may not mean anything and that allows critics to trample on your nice published study, if they don’t like it.

Big dilemma!

It’s a theme taken up by Eric J. Topol, MD, Director of the Scripps Translational Science Institute and Editor-in-Chief of Medscape Genomic Medicine and theheart.org and comes from a series he’s recording called The Creative Destruction of Medicine. The title itself should get the juices flowing in my subscribers.

According to Topol, we have this big thing about evidence-based medicine and, of course, the sanctimonious randomized, placebo-controlled clinical trial. Well, that’s great if one can do that, but often we’re talking about needing thousands, if not tens of thousands, of patients for these types of clinical trials. And things are changing so fast with respect to medicine and, for example, genomically guided interventions that it’s going to become increasingly difficult to justify these very large clinical trials.

For example, there was a drug trial for melanoma and the mutation of BRAF, which is the gene that is found in about 60% of people with malignant melanoma. When that trial was done, there was a placebo control, and there was a big ethical charge asking whether it is justifiable to have a body count [let some people die as “controls”].

This was a matched drug for the biology underpinning metastatic melanoma, which is essentially a fatal condition within 1 year, and researchers were giving some individuals a placebo.

That’s just letting them die.

Topol cites a more futuristic kind of study, which is targeted to small populations of a specific gene type. It has to come.

If he had his way, there would be an end to what he calls “the current contrived clinical trial environment”. These are some things that can change in the rebooting or in the creative destruction, or reconstruction, of medicine going forward.

See a short video by Topol here (not very exciting in itself): http://www.medscape.com/viewarticle/768635?src=ptalk

[SOURCE: Topol: Get Rid of the Randomized Trial; Here’s a Better Way. Medscape. Aug 20, 2012.]

Small Study, Excellent Outcomes

Here’s an example of an excellent small sample study done with the New Reality Master Key™ device (it’s something I recommend but don’t make). It doesn’t need thousands of individuals to make its point.

In a trial among the employees of Pratt and Whitney, 18 people took part and for 2 – 3 months they used the portable Master Key™ multi-modal sensory device for approximately 30 minutes each day.

Every single respondent to the follow-up survey reported ease of use and the calming effects. In addition:

92% reported being able to feel relaxed quickly

100% reported better sleep

100% reported reduction in stress

100% reported increased energy and awareness

To me that paints a picture of a device which is very effective indeed, despite the small number of cases. Factually, there is no need to prove that multi-modal sensory stimulation (MMSS) works: there are hundreds of scientific papers to show it does.

It just happens that the New Reality Master Key™ is the very best of this stable of devices. I call it electronic nutrition for the brain!

You can get yourself one here, with a full warranty and risk free (money-back guarantee):

Master Key device