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Nothing “incidental” about a clinical trial test result

Earlier this year, a good friend of mine had appendicitis.  During his time in the emergency room, he received a CAT scan, which confirmed the diagnosis, and he went into surgery.

The day he checked out of the hospital, his doctor came by.  While the appendectomy had gone well and my friend was healing well, the doctor had additional news – in addition to the appendicitis, the CAT scan had also revealed a spot on one of his kidneys.  Was it a tumor?  The doctor recommended he follow-up on it and referred him to another doctor.

In a recent article (and follow-up editorial) in the Archives of Internal Medicine, found here, the question was raised whether medical research participants should be notified of “incidental findings” that turn up on radiological reports but are unrelated to the research study’s intent.  Say you’re in a heart study and a chest scan (as required by the study’s protocol) indicates a spot on one of your lungs.  The debate was whether you should be told about the lung finding.  Maybe the person reading the radiology results isn’t really qualified to interpret them beyond the study parameters.  Or perhaps it’s a false-positive that will give you unneeded stress and require many other tests, which come with their own risks to you.  So, should you be told?

Are you kidding me?

One of the hesitations that people have about participating in clinical trials is the perception that the research is not really interested in the patient’s health, but rather in getting the data about the investigational medicine.  This is largely untrue.  But even to question the true motive hints that perception might sometimes be reality in this case.

While the primary purpose of medical research is gaining information about the investigational treatment, patients should feel (and truly realize) that they are getting the highest level of medical care by volunteering.  To suggest otherwise only undermines efforts to get more people to participate in medical research.  There should be no dilemma here – the patient should be told of the findings and provided resources for follow-up.  That extra bit of health security will only enhance the medical research experience in the eyes of the public.

As for my friend, thank goodness the doctor did say something.  It was a tumor on his kidney, necessitating more surgery.  Because of the appendicitis (it could have just as easily been an incidental finding in a clinical trial test), the tumor was caught early and my friend is now making a full recovery.

Posted by qd_admin on September 30th, 2010 :: Filed under Clinical Trials,Health Care
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2 Responses to “Nothing “incidental” about a clinical trial test result”

  1. Jeremy Wilkerson
    May 7th, 2011

    The FDA sees it’s role in the Clinical Research process as maintaining the safety during clinical trials. If the philosophy was geared more to “improving the health of the patient population” it might trickle down where this vision is implemented at the patient/MD interaction.

  2. Greg Vance
    August 21st, 2011

    I believe the issue why more clinical investigators do not include this provision in their Clinical Research SOPs is the issue of lawsuits or malpractice. It is the “right” thing to do, but does it cause more liability?

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