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Clinical research is a process by which you participate in a study
that is designed to answer specific questions.
And this involves all the medications that have been approved by the
Food and Drug Administration to be used
by a physician or
prescribed by a physician.
And it also includes
other types of treatments, such as different types of surgeries potentially,
different types of
devices that may be implanted, say like a defibrillator, that you
actually may have. And without the participation of individuals such
as yourself,
then we couldn't do those kinds of studies, and we wouldn't have all those medications that
are available for treatment
for chronic conditions such as high cholesterol,
to more advanced types of treatments for advanced cancer, etc.
I've done
clinical research for forty years at UCSD, and I'm an older person
who is very interested in healthy aging.
And so therefore I'm interested in the participation of older people
like myself
who could be in clinical trials.
Personally, for me, the program, what it has
contributed has been power.
The power to not be afraid of diabetes.
I know when my wife was first diagnosed with
multiple sclerosis, there was not one medicine
that they had for multiple sclerosis.
Now there's a number of new medicines and they're coming up with new medicine
every day.
And all of this was the developed through clinical research.
I was diagnosed with breast cancer a year ago, and there's a medication out
there,
that wasn't available ten or eleven years ago, and now it's
available.
And if it hadn't gone through clinical trials, that medication would not be
available.
And it's saved my life.
There are two different types of studies. One is an observational study where
nothing is
really done to you as a participant.
But the other type of research study is a clinical trial. We think of this as
an experiment.
We have to place you, as a participant, in one of two study arms.
And one of them may be taking the medication, and one of them may be taking a
placebo, which is like a sugar pill or something that doesn't have any effect.
It could be an intervention where we ask you to make a certain
behavior change,
and another group maybe just
seeing their doctor as they usually would, what we call usual care or standard of care.
This process of allocating individuals to one group or the other
is done randomly.
It is very important that we do it randomly, because it has certain
beneficial effects on the study, and the ability to find valid results from the study.
There is the possibility that I'm on a placebo.
I do not know that for a fact.
Once you understand its reason, you really have to compare the people who were assigned at random
to treatment 'x', or without treatment 'x', you have to understand that that's
the only way we can answer this question.
Research projects usually have
somewhat of a focus,
and in that focus may be certain criteria,
which you would need to qualify to be eligible.
And it's nothing personal, it's just that the research question is
focused on that group specifically. But we hope that that doesn't discourage you
from participating in other research that may be going on at the university
or elsewhere,
if you find it interesting to you and think it may be something you want to
do.
When I went into the study,
I was anticipating, you know, continuing until the end of it.
But I didn't quite qualify. And I was a little dissappointed, but not to
the point of 'oh, I'll never go into another clinical trial'. No, it
was just this one.
In order to qualify for the program,
you had to be in a certain range on your blood sugar. So there were blood
tests that were taken.
And then you were given the results of the blood test, and whether you qualified for the study or not.
The main thing is that
we are doing studies almost every week. Someone at this university is
starting a new study in a totally different area. We actually will probably
ask you, if you're not eligible for this study,
if we can have your permission to keep your name on a list.
So we could call you for another study.
As an investigator, I have found that people go into research for a lot of different reasons.
One day, I received a postcard.
And there's diabetes in my family, so I decided if I
became involved in this study, it may help me.
My wife and I were sitting at the dinner table, and
we were going through our mail.
And I saw this card, that says 'T Trial'. So I read a little farther, and it said
'Testosterone'.
I gave it to my wife, and I say 'what do you think of this?'
There was a friend that talked to me about a
program through the university which was for, what they call 'Diabetic Prevention Program'.
I have had a mother who was diabetic. I realized that,
unless
I took control, and I learned
how to manage this disease better,
I was certainly going to follow my mother's steps, if not worse.
If you have questions that are related to the study or not,
someone will call you back. Someone will reassure you. Someone will do whatever is
appropriate.
There's a wide variety of clinical research studies that are offered,
typically.
Some of which are quite short.
For instance, there are studies want to look at the effect of an intervention, or
taking medication for a very short period of time, maybe a few weeks.
And there's other studies that go on for many many years. And those are typically
more of the, what we call observational studies, what we talked about before. We want to
observe what happens to people over time.
You as a participant, a research participant,
once you enroll, you are not bound to remain in the study for the
entirety of that study.
So even if the study is one year, after two weeks you say, 'this is really not
what I planned on, what I anticipated', you can leave the study at that time.
You're not committed, like a dotted line,
like, "oh, well you signed it, so you have to do a year, you have to do six months". No.
It's a volunteer thing.
You were randomized, and I ended up in the medication part.
I could have opted out, and I knew that there would be benefits to being in the study.
So I made the committment to stay.
It's important that you as a potential research subject feel comfortable
enrolling in any clinical trial that you're considering.
And I think the first step is to
contact the site,
and get as much information as you can over the phone.
And they will probably do this when they contact you to recruit you. Ask questions.
And then, once you have that information, you can share that information
with your private physician if you'd like. And he can
counsel you on what he believes to be
the best course of action.
And then the third would be to consider
obtaining information about whether the study has received approval from the
Institutional Review Board.
This is called the IRB.
This is again required of all research studies that involve people.
So if the study that you're considering has not received approval from
this board, this IRB,
then you may want to consider being cautious about those kinds of studies.
A well-done trial
has a university-specific informed consent group,
that looks at the study design. And they decide whether the study is safe,
as safe as we can hope it to be,
whether it's been ethically designed, and specifically whether you know
what you're getting into.
So that's what's called an informed consent.
After going in, and
talking to the doctor, the nurse,
they put my mind at ease.
Now I have no anxiety about going in.
Everyone has their own motivations for participating in research.
But I think a general
concept would be that most of them want to do something for society.
They want the information to be for their grandchildren, or their children, so they
can benefit from whatever is found in the research.
People that have been in at least the trials that I've been doing,
are doing it because they want the answers
for the next generation of people.
Our medicine,
from back in the days when I was young until now,
has made leaps and bounds, and most all of it has
come from clinical research.
So I think we all should get involved some way or another.
You know, I think about my grandchildren and future generations, what we're doing now in this
study, will help them.
It's kind of like,
I put a grain of sand on the beach,
to make a big beach.
For the seniors,
try clinical trials. Spread the word.
Because it's out there for you.
And we need to get more involved.
And it
feels good to know you're giving back.