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Thread: Clinical Trials for Rare Cancers are run by monkeys

  1. #1
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    Thumbs down Clinical Trials for Rare Cancers are run by monkeys

    And I'm not sure that's much of an exaggeration.

    Why? Try doing some research into such trials. Given that the cancer is rare, generally much less is known about how to treat it, what works etc due to a sheer lack of patients. Right? Right.

    So you'd think trials would be LESS restrictive on who can get in to them and who can't, right? Right. A child could see this logic.

    But they can't. I'm amazed half of these trials even get off the ground. It seems to me some of the people running them care more about a perfect "pristine" patient base and the potential laurels they'll get from it than they do in the whole POINT in such trials, ie saving lives. Repulsive and asinine are far too kind words, but I can't post anything more accurate without getting zapped by mods.

    /rant

  2. #2
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    I understand your frustration (believe me), but I'm sure it's less about getting flawless patients and more about eliminating mitigating circumstances. It's just like any other scientific experiment: you need to be sure of what's causing what or your results will be inconclusive.

    I know that's little comfort and very counter-intuitive but we are talking lives. They need to be sure about this stuff.
    Last edited by Knightly; 11-21-2011 at 04:55 PM.
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  3. #3
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    Actually, if a drug is in later phase trials, they'll often make exceptions for use.

    From Wiki:

    Expanded access refers to the use of an investigational drug outside of a clinical trial by patients with serious or life-threatening conditions who do not meet the enrollment criteria for the clinical trial in progress. This type of access may be available, in accordance with United States Food and Drug Administration (FDA) regulations, when it is clear that patients may benefit from the treatment, the therapy can be given safely outside the clinical trial setting, no other alternative therapy is available, and the drug developer agrees to provide access to the drug. The FDA refers to such a program as an expanded access program (EAP). EAPs can be leveraged in a wide range of therapeutic areas including HIV/AIDS and other infectious diseases, cancer, rare diseases, and cardiovascular diseases, to name a few.

    There are several types of EAPs allowed in the United States. Treatment protocols and treatment INDs provide large numbers of patients access to investigational drugs. A single-patient IND is a request from a physician to the FDA that an individual patient be allowed access to an investigational drug on an emergency or compassionate use basis. When the FDA receives a significant number of requests (~10 to 100) for individual patient expanded access to an investigational drug for the same use, they may ask the trial sponsor to consolidate these requests, creating an intermediate-size group. “Compassionate use” is a more colloquial term that is not generally used by the FDA.
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  4. #4
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    Hmm. So they do. Thanks for the info, pbj11.
    Last edited by pbj11; 11-19-2011 at 01:00 AM.
    31-year-old agnostic survivor of low-grade oligo-astrocytoma, diagnosed 6/17/11.
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  5. #5
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    Quote Originally Posted by Knightly View Post
    I understand your frustration (believe me), but I'm sure it's less about getting flawless patients and more about eliminating mitigating circumstances. It's just like any other scientific experiment: you need to be sure of what's causing what or your results will be inconclusive.
    Don't take this wrong but that doesn't make any sense to me. You cannot eliminate "mitigating circumstances" for one, and I'm not sure you should even want to. Simply annotate them as applicable and if anything it expands your knowledge base, ie well it worked 10% of the time for this group but with people having X circumstances it worked 15% of the time so maybe there's something about that X, etc etc.

    I know that's little comfort and very counter-intuitive but we are talking lives.
    Which is EXACTLY why they should be LESS restrictive, not more. People applying for trials are typically doing so as a last resort. The more you let in, the more you're likely to help.

    They need to be sure about this stuff.
    ? Sure about what stuff? Precious little if anything is a sure thing re. clinical trials.


    Thx pbj for the info. That is another frustrating thing about trials, ie how hard it is to find this stuff out...it's like digging for gold. God forbid all this info be in big bold letters somewhere (like say oh the government sites and sites where trial info is given etc etc?).

 

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