Friday, December 15, 2017

Clinical Trial Exclusions

A recent SEER report looked at the incidence of  previous cancer diagnoses in newly diagnosed patients. An average of 18% of newly diagnosed cancer patients have previously been diagnosed with cancer. (25% of  patients over the age of 65 and 11% of those under 65.)  All these people will also probably exempted from any clinical trials for their new cancer because of their previous cancer.

"The investigators concluded: “A substantial proportion of patients diagnosed with incident cancer in the United States have survived a prior cancer. These patients may be excluded from clinical trials and underrepresented in observational research, and little is known about their treatment and survivorship needs. Understanding the nature and impact of prior cancer is critical to improving clinical trial accrual and generalizability, disease outcomes, and patient experience.”"

I am in this group with two cancers before the age of 50. I have never participated in a clinical trial. Why? Because my previous cancer always exempts me.

While I understand that clinical trials try to keep their participants as homogeneous as possible to prove product safety. However, the problem is it excludes a lot of people. Why should my medical history bar me from potentially benefiting from a clinical trial medication? And why can't I help future medical care by participating in a clinical trial? And its not just me, its the other 18% of the population which already has had cancer and has been diagnosed with another one.

I just took a peek at a few trials over on clinicaltrials.gov and easily found some with exclusions that include:
  • Prior cancer diagnosis or chemotherapy treatment.
  • Active autoimmune disorder.
Here I would not be accepted because of my two cancer diagnoses, chemotherapy, and active RA. (This can make me feel like no one loves me.... and I could get a complex here.)

I think it is time that clinical trails reflect the population - we are aging, we have medical histories, 18% of us have lived through cancer. 18% of clinical trials should include patients with a history of cancer. We live through cancer but we can't participate. Not fair to us nor to future patients who might benefit from our medical histories.

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