Help for Evaluating Internet "Clinical Study" Data

Discussion in 'Fibromyalgia Main Forum' started by mme_curie68, Apr 5, 2006.

  1. mme_curie68

    mme_curie68 New Member

    Keep in mind that many people misrepresent themselves, especially in internet advertising. I see it every day when I get my FDA regulatory updates - they have their own little division that deals with web marketing and fraudulent claims for supplements and prescription drugs alike.

    A Ph.D. or M.D. after their name may be fraudulent. I have seen many "articles" on the internet that loosely resemble legitimate clinical studies and data that conclusively "proves" their particular point.

    One of the ways you can do a little check yourself is to look at the end notes - are all the "scholarly" references circular (written by the same "authors" )as the current "study"??? Dead giveaway.

    How about sample size? 10 - 12 people or less? Even FDA bioequivalence studies are conducted with a minimum of 26 - 30 patients. The larger the subject pool, the greater the statistical "power" of the data generated.

    How a study is conducted is another "tell" - is it a randomized, two-way, double -blind cross-over study with placebo control? This is the most legitimate kind of study because neither the medical staff at the clinic or the patients themselves know what they are receiving, be it the "reference drug" - the standard against which another drug is being tested or the "test article" the drug of interest or placebo.

    If a clinical trial is "open-label" that means that both the investigators and patients KNOW what they are receiving. This introduces bias into the results.

    Generally, open-label trials are only conducted when the data received in a blinded study indicate overwhelmingly that all the patients participating in a study would derive benefit from receiving one drug over another or no drug (placebo).

    For example, when AZT for HIV was first being developed, the study data was so favorable to treatment with AZT than without for reducing viral load, that the blinding was removed from the study and ALL patients were given the drug. It is considered unethical to continue a blinded study when a clear positive treatment effect is observed versus a placebo (no drug).

    Last but not least, is the study published in a legitmate peer-reviewed (JAMA, Science, The Lancet (Brit top dog), New England Journal of Medicine, "Journal of xxxx specialty" research publication and was it conducted by legit. clinical investigators at a legitimate clinical research facility, legitimate university or legitimate medical facility?

    Peer-reviewed research conducted under Good Clinical Practice regulations is considered the gold standard because the journal articles are sent round to be reviewed by a scientist's peers (and usually their fiercest competitors and critics in the research world) - if knowlegeable, educated peers in the same specialty as the author consider an article acceptable for publication, more legitimacy can be granted to the results.

    Hugs,
    Madame Curie
  2. mme_curie68

    mme_curie68 New Member

    Bumping to share...