When I met the orthopedic surgeon last Tuesday he mentioned I could take part in a double-blind research study of a new drug, a blood thinner. He added that this drug is, "not approved by the United States Food and Drug Administration." Not yet, at least. It will be compared with a drug that is approved by the FDA for the prevention of deep vein thrombosis (DVT) and pulmonary embolism (PE) after knee replacement surgery.
He gave me a 14 page contract-like legal document -- an Informed Consent Form -- and asked me to read it and decide, by the time of my pre-op interview at the hospital, if I would take part.
I have decided not to participate. The study appears to require a lot of followup visits and some tests that sound intrusive and stressful. Lots of visits to medical offices.
Am I expected to participate? I feel awkward turning it down, but I really don't want to be part of it. Deciding on having the knee surgery itself was a huge step for me. Now this question comes up. I am sure the surgery and recovery will be quite stressful enough without adding any more stress factors.
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2 comments:
They would rather you say no than say yes and then drop out.
My mom is participating in an Alzheimer's drug study and it's a pain to go to all the appointments and do all the tests. It's especially annoying since I'm pretty sure she's getting the placebo.
Sorry to hear your mom is in a test you think may be using the placebo. Do you know anybody else in the study who's doing extremely well?
I found out they want me in there at 5:00 A.M. next Thursday. I told the nurse I never stay up that late but she was immune to my humor, or charm for that matter.
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