Wednesday, December 2, 2009

But, why didn't I qualify?

It can be frustrating to learn that you don't qualify for a clinical trial that you were interested in.  The ad that you saw in the paper said that the research site was looking for someone willing to volunteer for a clinical trial for the condition that you have and you meet the criteria that the ad said were required in order to participate.  So, what's the deal?  Why didn't I work?

Actually, it's not that you didn't work at all.  It's actually that the clinical trial didn't work for you- it wasn't a good match for you.  You do have the condition and you do meet the criteria that were in the ad.  The problem is that all clinical trials have a long list of entry requirements that participants have to meet in order to be eligible to participate in it, so eligibility goes way beyond the condition that you have and the basic entry criteria for the trial.  It includes things like: lab criteria that have to be met, your past medical history, other symptoms that you may experience or how often you experience those symptoms, how long you've had that condition, and what other medications you are currently taking or even medications that you have taken recently- to name a few. These criteria exist for one reason only- to keep you safe and minimize risks to your health while you're in a trial.

Anyone conducting a clinical trial is required by law to ensure that a participant is a 100% match for a clinical trial testing an investigational medication (a medication that is not approved by the FDA).  If you aren't a match for the trial that you're interested in, it could mean that you might be more likely to have a reaction to the study medication, or your condition could worsen as a result of taking the study medication, among other reasons.  It's not that the research site doesn't want you for the trial, it's just that the researcher is doing her job and protecting your health and well-being, by not putting you in that specific trial.  If a trial isn't a good fit for you, always be sure to ask if there is another trial that might be a better match for you.  Clinical trials are like shoes, you have to try on a few for size before you find the one that fits you the best and that you will be able to wear for awhile!

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