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What Constitutes A "Good" Scientic Trial?

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General fitness, health and nutrition
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5 February 2004
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  1. 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?

  2. <[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?

    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

  3. 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?

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

    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

  5. 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.

    http://tinyurl.com/3e8j8

    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

  6. 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).

  7. <[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.

  8. 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 http://www,google.com and type in What makes a good
    clinical trial?

    How difficult is that?

    Jan

  9. 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.

  10. 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.

  11. 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?"

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

    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.

    http://tinyurl.com/3e8j8

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

  13. "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.

    http://tinyurl.com/3e8j8

    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.

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