It is a known fact that clinical trials are very selective when creating their selection criteria for who to include. (That is not a grammatical sentence but its early in the day here.) What I am trying to say is that if you do not fit their criteria, you will not be included. I have so many ailments, I have never been included in a clinical trial. They don't want me.
Hop on over the clinicaltrials.gov and see if you would fit their criteria for any. They are very specific. Basically they are trying to determine toxicity, dosage and more. An abbreviated version of the official government description of the different stages are:
"Phase 0: Exploratory study involving very limited human exposure to the
drug, with no therapeutic or diagnostic goals (for example, screening
studies, microdose studies).
Phase 1: Studies that are usually conducted with healthy
volunteers and that emphasize safety.
Phase 2: Studies that gather preliminary data on effectiveness
(whether the drug works in people who have a certain disease or
condition).
Phase 3: Studies that gather more information about safety and
effectiveness by studying different populations and different dosages
and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for
marketing. These including postmarket requirement and commitment studies
that are required of or agreed to by the sponsor."
In Phase 2 and 3 trials, the most common ones we hear about and participate in, are where the drug manufacturers select their groups of patients who have the disease that they hope to treat. But they routinely exclude people with other issues who might not conflict with the trials or cause side effects that could be from the new drug or from the other issues. So you have to be perfect.
A growing problem is that with the aging population as the Boomer generation about to hit their 70s, older patients are being treated with new drugs that have not been tested on their age group.
"For at least 25 years, it’s been known that drugs that work one way in
an otherwise healthy younger adult might not work the same way in the
elderly. Many older adults are frail and might metabolize medications
more slowly or suffer unforeseen drug interactions. Blood thinners, for
example, might be riskier in someone with a tendency to fall.
Medications to control blood pressure could be harder to dose
appropriately in a patient with poor kidney function. In 1989, the FDA
set guidelines encouraging drug companies to study how their drugs
affect the elderly, with the goal that the population being studied
prior to drug approval should resemble the population that would
ultimately take the medications. But the guideline was not a mandate...."
"...one in five trials excluded potential participants based on their age
alone. In half of the remaining trials, patients were excluded from
participating because of conditions that disproportionately affect older
adults, such as cognitive dysfunction or limited physical activity. And
only one quarter of the studies looked at outcomes that might be
relevant to older adults, such as quality of life or physical function."
So for all of us imperfect people out there, you can understand the issues here with multiple health issues, never mind age, which may cause us additional problems through treatment.
Subscribe to:
Post Comments (Atom)
I Started a New Blog
I started this blog when I was diagnosed with breast cancer in 2007. Blogging really helped me cope with my cancer and its treatment. Howe...
-
I started this blog when I was diagnosed with breast cancer in 2007. Blogging really helped me cope with my cancer and its treatment. Howe...
-
I'm finally back in the blogosphere. (I'm not sure I like that term but I'll use it). Blogging really helps me cope with life. I...
-
Yesterday I had a (not so fun) back procedure. As my arm has been acting up, I wore my lymphedema sleeve on my left arm. I am going to the l...
No comments:
Post a Comment