What Constitutes A "Good" Scientic Trial?

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Quoted message said:

Is it the number of participants? The record-keeping? The protocol itself? Or is a "good" vs. "not-so-
good" testing/trial in the eyes of the beholders? I ask this as I see so many trials that are
pronounced inherntly "flawed" (I guess "they" mean sloppy??), so I have to wonder why bother? Or
are even these of some use? Are acceptable/good trials just more expensive to do?

Whether a trial is good has everything to do with trial design. Is the number of participants, given
the expected variation in the results, sufficient to obtain statistical significance? Has the trial
been randomized in a good fashion? Has the correct statistical analyses been employed? Are the
outcome measures sufficiently objective, or is there room for e.g. observer bias? Trial design is a
study in itself and it's really no wonder so many researchers do it wrong.

--
Robert Bronsing

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Quoted message said:

Is it the number of participants? The record-keeping? The protocol itself? Or is a "good" vs. "not-so-
good" testing/trial in the eyes of the beholders? I ask this as I see so many trials that are
pronounced inherntly "flawed" (I guess "they" mean sloppy??), so I have to wonder why bother? Or
are even these of some use? Are acceptable/good trials just more expensive to do?

The most common problem with trials that surface from alternative medicine is an absence of or
inadequacy of "controls". They are like the blanks which are always used in laboratory experiments
to control for any impurities or variability in the reagents being used, or variable environmental
conditions, e.g. lab temperature will affect the rate of many chemical and in vitro reactons.

There are even more such factors in clinical research -even the colour of pills has been found to
influence "response rates", and "response rates" often depend merely what the patient says to the
researcher later on. That can be affected by such factors as experimental subordination and "answers
of politeness". Most patients try to get better or will say they are better if it seems the "right"
or polite thing to do. This is partly why there are so many charlatans about.

But the largest influence that has to be controlled for is spontaneous cures or fluctuations in
level of symptoms.

That's only the start. There is the qualitiy of randomisation, single or double-blinded?, are the
results being massaged post hoc in various ways or being "cherry-picked" (both very common in
alt.med, and also in conventional medicine) .

Peter Moran

Results! Anth

<[email hidden]> wrote in message "]news:[email hidden]...

Quoted message said:

Is it the number of participants? The record-keeping? The protocol itself? Or is a "good" vs. "not-so-
good" testing/trial in the eyes of the beholders? I ask this as I see so many trials that are
pronounced inherntly "flawed" (I guess "they" mean sloppy??), so I have to wonder why bother? Or
are even these of some use? Are acceptable/good trials just more expensive to do?

Quoted message said:

Subject: What Constitutes A "Good" Scientic Trial?
From: [email hidden]
Date: 2/5/2004 10:38 AM Pacific Standard Time
Message-id: <[email hidden]>

Is it the number of participants? The record-keeping? The protocol itself? Or is a "good" vs. "not-so-
good" testing/trial in the eyes of the beholders? I ask this as I see so many trials that are
pronounced inherntly "flawed" (I guess "they" mean sloppy??), so I have to wonder why bother? Or
are even these of some use? Are acceptable/good trials just more expensive to do?

It all depends of who is paying for these trials.

Scientists for hire.

tinyurl.com3e8j8Open ↗

Deceptive Drug Trials

January 21, 2004

Deceptive Drug Trials

Do you trust the results of various drug trials that show the effectiveness and safety of a new
medication? In an ideal world, you should trust them at least somewhat - but we don't live in an
ideal world. No, we live in a world where untrustworthy and unsavory characters twist the truth and
use undue influence in order to make things appear favorable to them... including drug trials. The
Guardian reports:

A review published in 2003 found 30 studies that had compared the results of trials funded by drug
companies with those funded from other sources. Trials funded by companies were four times more
likely to have results favourable to them than those funded by others. Yet the technical quality of
the trials funded by drug companies was always as good and often better than the quality of those
funded by other sources. This is not surprising, as drug company trials are tightly regulated. There
are explicit high standards, and companies can afford to hire the best to conduct the trials. How
does this happen? Researchers can readily reach the results they want (and the results that the drug
company paying for the trials wants); in fact, Dave Sackett and Andy Oxman have founded a "spoof
company" called Harlot (How to Achieve positive Results without actually Lying to Overcome the
Truth) which teaches ways in which to get even a completely ineffective drug to show positive
results in tests.

One of the commonest methods is to test a new drug not against an effective treatment but against a
placebo. Ironically, regulators often require companies to do this. But what matters to patients is
not whether a company's drug is better than nothing, but whether it is better than established
treatments. Companies are nervous about these "head-to-head" trials, particularly if many drugs are
being tested - because there may be only one winner and many losers. A huge publicly funded head-to-
head trial of treatments for high blood pressure was published recently and threw companies into a
tizz because it showed that long-established drugs that are off patent were better than newer, much
more expensive drugs. Of course, even if you use a head-to-head trial, you can still rig it. One
method is to compare against an inadequate dose of the competitor's product - another is to use an
excessive dose, thus showing that the competition has worse side effects. Finally, you can do a
trial with a sample size so small that it can't possibly show that the competitor is better or
worse, thus allowing you to claim that you are just as good.

Seventy percent of all drug trials are funded by the pharmaceutical industry. Almost all drug
research is done by the pharmaceutical industry. The companies in this industry put most of their
funding in trials which work, thus leading to massive incentives to cheat - and, apparently, there's
a lot of cheating going on.

If you see a drug being touted on the evident of drug trials, ask who funded the trials. If the
funding came from the company, then don't trust the results.

Jan

"Anth" <[email hidden]> wrote in message
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Quoted message said:

Results! Anth

Oh no!!! Always be suspicious of trials where the results seem too good to be true, or too
favourable for the interests of the researchers.

Peter Moran

Jan, what an inadequate article. Absolutely nothing concrete to back up their allegations. Not one
fact presented that had any data which a responsible newspaper should include. If I wanted to look
into those unamed 2003 studies I wouldn't even begin to know where to look. You should be ashamed of
yourself for even publishing such a useless piece of writing. But I presume you did some actual
research yourself into the subject so you wouldn't end up with egg on your face & you can fill us in
(maybe IN YOUR OWN WORDS for a change).

<[email hidden]> wrote in message
"]news:[email hidden]...

Quoted message said:

Jan, what an inadequate article. Absolutely nothing concrete to back up their allegations. Not one
fact presented that had any data which a responsible newspaper should include. If I wanted to look
into those unamed 2003 studies I wouldn't even begin to know where to look. You should be ashamed
of yourself for even publishing such a useless piece of writing. But I presume you did some actual
research yourself into the subject so you wouldn't end up with egg on your face & you can fill us
in (maybe IN YOUR OWN WORDS for a change).

You are in BIG trouble (wth Jan) lady.

Quoted message said:

Subject: Re: What Constitutes A "Good" Scientic Trial?
From: [email hidden]
Date: 2/5/2004 1:29 PM Pacific Standard Time
Message-id: <[email hidden]>

Jan, what an inadequate article. Absolutely nothing concrete to back up their allegations. Not one
fact presented that had any data which a responsible newspaper should include. If I wanted to look
into those unamed 2003 studies I wouldn't even begin to know where to look. You should be ashamed
of yourself for even publishing such a useless piece of writing. But I presume you did some actual
research yourself into the subject so you wouldn't end up with egg on your face & you can fill us
in (maybe IN YOUR OWN WORDS for a change).

I guess the truth leaves some people with this reaction.

I suggest you go to www,google.comwww,google.comOpen ↗ and type in What makes a good clinical trial?

How difficult is that?

Jan

Although trials being apparently funded 70% from pharmaceuticals, there should be some organism in
charge of controlling the processes and verifying the results objectively, or isn´t it ?

"Jan" <[email hidden]> wrote in message "]news:[email hidden]...

Quoted message said:

Quoted message said:

Subject: Re: What Constitutes A "Good" Scientic Trial? From: [email hidden] Date: 2/5/2004
1:29 PM Pacific Standard Time Message-id: <[email hidden]>

Seventy percent of all drug trials are funded by the pharmaceutical industry.

Quoted message said:

Is it the number of participants?

Yes. You have to have enough participants in both groups that the results are unlikely to be
influenced by the random fluctuations that are inherent in small samples. The rarer the thing you
are studying, the larger the samples have to be.

Quoted message said:

The record-keeping?

Yes. Any claim of a AIDS or cancer "cure", for example, needs to follow the patients for several
years and report those outcomes, or specify how long they followed the patients.

Quoted message said:

The protocol itself?

Yes ... many studies are flawed by design and can't prove what they are trying to prove because they
aren't asking the right questions. Or failed to exclude factors that affect outcomes.

Quoted message said:

Or is a "good" vs. "not-so-good" testing/trial in the eyes of the beholders? I ask this as I see
so many trials that are pronounced inherntly "flawed" (I guess "they" mean sloppy??), so I have
to wonder why bother? Or are even these of some use? Are acceptable/good trials just more
expensive to do?

Tsu Dho Nimh

--
When businesses invoke the "protection of consumers," it's a lot like politicians invoking morality
and children - grab your wallet and/or your kid and run for your life.

In article <[email hidden]>,

Tsu Dho Nimh said:

Quoted message said:

Is it the number of participants?

Yes. You have to have enough participants in both groups that the results are unlikely to be
influenced by the random fluctuations that are inherent in small samples. The rarer the thing
you are studying, the larger the samples have to be.

Also, the smaller the difference due to treatment, the larger the samples need to be. It's all a
matter of statistical power. For diseases in which there is a wide variability in clinical course or
for treatments that cause only a small effect compared either to placebo or to the best standard of
care treatment available, large numbers of patients are needed. For large effects, smaller numbers
are needed.

This brings me back to altie claims. Altie claims of miraculous efficacy for some of their remedies
would be very easy to demonstrate in a controlled trial, if they were, in fact, real. If the
treatment effect is truly so striking, it would not take very many patients in each group to
demonstrate it. Also, if the treatment effect were truly so striking, it would show up even in the
face of a number of methodological flaws. So why haven't they been validated? The best possible
reason is that there is an effect, but it is modest and not detected in smaller studies. But then
that would repudiate the claims of miraculous "cures" and place such "alternative" therapies in the
same league as the hated conventional therapies that alties would like to see supplanted by
"alternative" therapies.

Quoted message said:

Quoted message said:

The record-keeping?

Yes. Any claim of a AIDS or cancer "cure", for example, needs to follow the patients for several
years and report those outcomes, or specify how long they followed the patients.

Indeed. For instance, most cancer is not considered "cured" until five years of disease-free
survival. For some cancers, like breast cancer, where late recurrences are more common, one has to
be free of disease for at least ten years to be considered "cured."

Quoted message said:

Quoted message said:

The protocol itself?

Yes ... many studies are flawed by design and can't prove what they are trying to prove because
they aren't asking the right questions. Or failed to exclude factors that affect outcomes.

Indeed. Experimental groups need to be balanced in terms of factors that might affect the results.
This can be VERY difficult.

--
Orac |"A statement of fact cannot be insolent."
|
|"If you cannot listen to the answers, why do you inconvenience me with questions?"

[email hidden] (Jan) wrote in message news:<[email hidden]>...

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Quoted message said:

Subject: What Constitutes A "Good" Scientic Trial? From: [email hidden] Date: 2/5/2004 10:38
AM Pacific Standard Time Message-id: <[email hidden]>

Is it the number of participants? The record-keeping? The protocol itself? Or is a "good" vs. "not-so-
good" testing/trial in the eyes of the beholders? I ask this as I see so many trials that are
pronounced inherntly "flawed" (I guess "they" mean sloppy??), so I have to wonder why bother? Or
are even these of some use? Are acceptable/good trials just more expensive to do?

It all depends of who is paying for these trials.

Scientists for hire.

tinyurl.com3e8j8Open ↗

The URL doesn't link to the article -- it just opens up a "diet-patch" ad.

"soft-eng" <[email hidden]> wrote in message
"]news:[email hidden]...

Quoted message said:

[email hidden] (Jan) wrote in message

news:<[email hidden]>...

Quoted message said:

Quoted message said:

Quoted message said:

Subject: What Constitutes A "Good" Scientic Trial? From: [email hidden] Date: 2/5/2004 10:38
AM Pacific Standard Time Message-id: <[email hidden]>

Is it the number of participants? The record-keeping? The protocol itself? Or is a "good" vs.
"not-so-good" testing/trial in the eyes of the beholders? I ask this as I see so many trials
that are pronounced inherntly "flawed" (I guess "they" mean sloppy??), so I have to wonder why
bother? Or are even these of some use? Are acceptable/good trials just more expensive to do?

It all depends of who is paying for these trials.

Scientists for hire.

tinyurl.com3e8j8Open ↗

The URL doesn't link to the article -- it just opens up a "diet-patch" ad.

That's OK. Jan uses advertising for proof all the time. In fact, according to JanLogic, advertising
for atlernative treamtnets are 100% believeable.