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Wednesday, November 11, 2009

Clinical Trial Shenanigans I just cannot comprehend regarding age range and placebos.

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From what I have learned in the past couple of years, it seems like many times the hospital doctors are actually pretty accurate when it comes to diagnosing advanced cancer cases and how much longer someone is expected to live.

While there will always be cases in which the doctors prognosis is wrong, they seem to know pretty accurately most of the time. Yet when I look at clinical trial studies, the studies seem to require that perhaps as many as half of the patients actually receive only a placebo.

Do we really really need placebo'd patients in later stages of a disease progression clinical trial study when hospital doctors already seem to know how long someone is going to live based on past examples?

If placebos are required, does it really have to include nearly half of the people involved in the clinical trial regarding cases of an advanced disease?

If you were hopeful of having your terminally diagnosed life saved by an experimental treatment that just might work, would you want to be among the half that got the placebo instead? Probably not. Even if the percentage of those given a placebo was much smaller, would you still find it acceptable if you got the placebo when you really wanted the treatment?

If you were age 76, and the clinical trial age range cut off was 75, wouldn't you wonder why you couldn't be part of the study anyways if you had already been diagnosed as terminal?

If Doctors in hospitals have gotten pretty good at diagnosing later stages of cancer, and that cancer patient is willing to try a clinical trial that has already been approved by the FDA, why can't the regimentation of the trial be made available to those who want to fight for their own life even if they don't live in the state where the clinical trial is going on?

If a clinical trial was being done in Texas, but you lived in Ohio, wouldn't you want the choice to be part of the clinical trial by having a hospital in Ohio follow the protocol of the clinical trial being done in Texas? Especially if flying to Texas might weaken your health and already alter the result?

If the answer is, the longer people live, the more they receive in social security benefits and the more they cost "the health care system", then just make that sentiment public knowledge and be done with it.

Isn't it time to allow older men and women who have been terminally diagnosed to be part of a clinical trial even if they can't travel to the place the trial is being done, don't want the placebo, or are "too old" under the current system as it is currently structured?

Is that really asking for too much?

(Edit note, just two nights ago (Nov. 17, 2009), I heard a report, I think it was on ABC nightly news about the mammogram controversy, and the story claimed it was difficult to find people to participate in clinical trials! Perhaps the idea of getting a placebo discourages people from getting involved.)

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