Dear minisophiesteve-ga;
Thank you for allowing me an opportunity to answer your interesting
question. First off, your ?Phase Four? scenario might not work
depending on how realistic you?d like the story to be. You see, the
term ?Phase? is already a categorization used in Clinical Studies, and
while UI understand what you mean by it (late stage of a clinical
trial) you will not be able to use that particular term to describe
it. Here?s why (I will address your ?phase 4? question now because it
stuck out as the most obvious faux pas):
?Most clinical trials are designated as phase I, II, or III, based on
the type of questions that study is seeking to answer:
In Phase I clinical trials, researchers test a new drug or treatment
in a small group of people (20-80) for the first time to evaluate its
safety, determine a safe dosage range, and identify side effects.
In Phase II clinical trials, the study drug or treatment is given to a
larger group of people (100-300) to see if it is effective and to
further evaluate its safety.
In Phase III studies, the study drug or treatment is given to large
groups of people (1,000-3,000) to confirm its effectiveness, monitor
side effects, compare it to commonly used treatments, and collect
information that will allow the drug or treatment to be used safely.
These phases are defined by the Food and Drug Administration in the
Code of Federal Regulations.?
ClinicalTrials.gov
http://www.clinicaltrials.gov/ct/info/phase
So you see, the term PHASE already describes a very important TYPE of
trial as opposed to the layman?s term ?phase? which describes a STAGE
of a trial; and the latter terminology is almost never used in a
clinical trial.
Ok, let?s talk trials and what they are about:
If you go to this link you will find a number of depression studies
that are recruiting participants. What initially got my attention was
that one of them ironically involves pramipexole ? an FDA approved for
Parkinson's disease. On the right column near each study you will find
a link that says ?Detailed Protocol Description?. This will provide
the details of each study, the goals and objectives, and what is
typically required/expected of study participants.
NATIONAL INSTITUTE OF MENTAL HEALTH
http://patientinfo.nimh.nih.gov/DepressionAdult.aspx
The pramipexole study I mentioned above, for example, is a 9-week, two
phase study. In a nutshell, Phase one goes thusly:
?During the study, participants come to the clinic eight times for
health assessments and symptoms assessments, which include a check of
vital signs and rating scales for depression and anxiety, adverse
events, and sexual functioning. Blood and urine samples are collected
periodically to monitor health, detect pregnancy in women, and detect
illicit drug use. At the end of the 6-week treatment period,
participants have a physical examination, ECG, blood test, and check
of vital signs. Short-term anti-depressant treatment is offered, and
plans are made for long-term treatment.?
DEPRESSION (ADULT) RESEARCH STUDY
PRAMIPEXOLE AND ESCITALOPRAM TO TREAT MAJOR DEPRESSIVE DISORDER
http://www.clinicaltrials.gov/ct/show/NCT00086307?order=1
Believe it or not, I have since found another that actually involves
Parkinson?s patients, but it is an outpatient study requiring 15 (or
so) hours over 4 or 5 outpatient visits. Here though is where you can
take literary license.
The study requires PET scans and MRI?s of participants while they are
off their medications. These are time consuming procedures and I can
see where you, for the purposes of your book, might easily make these
visits 2 or 3 day inpatient stays, especially, say, if you were to
also work in sleep studies, such as apnea, dream disturbances, EEG?s,
insomnia and so forth that requires patients to sleep in the monitored
clinical setting over night several times throughout. See what I mean?
In my opinion you could pull this off and make it so believable that I
think even a clinician would have a difficult time saying for sure
that such a study never occurred.
PARKINSONS DISEASE RESEARCH STUDY
COGNITIVE FUNCTION IN PARKINSON'S DISEASE: RELATIONSHIP TO CORTICAL
DOPAMINE SYNTHESIS AND DOPAMINE D1 RECEPTORS
http://patientinfo.nimh.nih.gov/ParkinsonDisease.aspx
The scenario? Why not make the sleep issue a major problem with your
patient and have the woman referred to a trial wherein your candidate
drug and sleep studies such as the ones I mentioned are conducted.
This provides the necessity of having your patient ?reside? at the
testing facility. Make the study a couple of weeks or make it many
weeks ? that really doesn?t matter. What will matter is that the
jargon regarding activities, equipment, and lab, etc. commonly found
in a sleep study setting are accurate. It doesn?t matter for the
purposes of the sleep study that the woman in your story has
Parkinson?s, neither would it matter in a Parkinson?s study if the
woman had, say, sleep apnea. The accuracy, I think, will only come
into question if your jargon about the goings on there is wrong. The
truth that we (apparent by our interaction here) don?t know a lot
about clinical trials unless we?ve participated in one ? and few of us
have, as you can see. Unless your target audience is clinicians and
you are worried about pulling off a fictional scenario with them, I
think you can bamboozle the majority of laypeople without much effort.
Why aren?t more residential clinical studies being conducted? Good
question. The National Institute of Mental Health (NIMH) at the
National Institutes of Health (NIH) at Bethesda, Maryland is an
enormous research hospital that resembles (sarcasm) a small city.
DRAWING: http://patientinfo.nimh.nih.gov/images/smallcc.gif
While hundreds of studies are conducted there involving thousands of
patients, and hundreds of other studies are going on in other clinics
around the world, the fact of the matter is that this is a drop in the
bucket compared to the millions of people who suffer from studies
ailments. In other words, only a portion of the people who have
researchable illnesses will ever clinically represent the majority. Is
it because of cost? Probably not since pharmaceutical companies are
more than capable of spending the millions of dollar necessary to
completed FDA mandated trials. My guess is that it just isn?t
geographically accessible to most people and the rewards of free
medications and nominal financial compensation are just not large
enough incentives to attract someone to a study. Add to that the
further disruption of their already seriously disrupted lives and also
the ugly possibility that they might receive placebos or unproductive
and/or unsuccessful treatment in exchange for their trouble. If you
measure cost in more than just money, cost may indeed be an issue. For
many unhealthy people (and sadly those with Parkinson?s who are
typically geriatric and nearing end life stage chronologically even
without the disease) perhaps the cost of the gamble is simply not wise
considering the natural odds against them.
I hope you find that my research exceeds your expectations. If you
have any questions about my research please post a clarification
request prior to rating the answer. Otherwise, I welcome your rating
and your final comments.
In closing, I will take your offer to do further research for you. I
welcome your next question and look forward to working with you again
in the near future.
Best regards;
Tutuzdad ? Google Answers Researcher
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