Pharmaceutical Research

What is the market for Phase IV pharmaceutical research? Total number

of trials, total number of subjects.



One thought on “Pharmaceutical Research

  1. Hi denny!

    According to the database at ClinicalTrials.gov, there are currently

    115 Phase IV clinical trials underway. To obtain this information, I

    went to:

    http://www.clinicaltrials.gov/ct/gui/screen/AdvancedSearch

    …and selected "Phase IV" as my search criteria, then selected "Show

    all trials, including those no longer recruiting patients." This

    results in a list of all Phase IV trials. Clicking each link will

    take you to a page listing the purpose of the study and the contact

    information for the director/sponsor of each study.

    Information regarding total number of participants in Phase IV studies

    is not available, according to a representative at the Food And Drug

    Administration (1-888-INFO-FDA). She said that the number of study

    participants is considered proprietary information by most drug

    manufacturers – many will not release this number to the public during

    testing. You may have some luck obtaining the number of participants

    in each trial by calling the contact person listed with each trial's

    information – however, I called 5 at random and was turned down flatly

    by 4 of them. The fifth gave me a rough number, but informed me that

    they had no idea how many would actually be participating until

    recruiting ceased.

    After Phase IV testing is complete, you can obtain information about

    the number of participants in each trial by filing a Freedom Of

    Information Act request *for each trial*:

    Freedom of Information

    http://www.fda.gov/foi/foia2.htm

    The FDA representative told me that no information is released without

    the specific drug name, and a separate request must be made for

    *each*.

    Something that might be of further interest is a chart included with

    this article about clinical trials, which explaing the various phases

    of testing, and gives rough estimates of the number of patients used

    in each phase of each trial.

    The Drug Development and Approval Process

    http://www.phrma.org/searchcures/newmeds/devapprovprocess.phtml

    Hope this helps!

    –Missy

    Search terms included: [ "phase IV" trials total participants ]

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