After you have determined whether you
want to participate in an In-Patient or Out-Patient,
you must decide what you want to test.
This is the most common type of study you will
see. You will take one or more doses during your stay or
The first time a drug is given to human test
subjects, it will more than likely be done as a "Double-Blind"
Placebo controlled study. What this means is that not all
of the test subjects will receive the study drug. If there
are 10 subjects, 6 to 8 will receive the study drug and the
remainder will receive a placebo, or inactive substance.
"Double-Blind" means that neither you or any of the nurses or
technicians will know who is getting the real drug and who is
getting the placebo.
Some studies will be done as "open-label" which
means that everyone will get the study drug. You will know
exactly what you are getting. Typically these are late Phase 1
Some studies are "bio-equivalency" to compare a
generic drug to the brand name drug. You will typically
come in for two stays of equal length and take 1 drug during the
first stay and the other drug during the second stay with a
period in-between for "wash-out".
Multiple drugs may be tested at one time.
You may take one drug for one period and then take another drug
for a second period and then take both drugs during a third
period. Or you might take one drug for a few days and then
add a second drug.
As you can see there are many different dosing
scenarios. Be sure to pay attention to the informed
consent form. This will outline in detail the drug(s) you
will be taking, how they will be administered, how much and
Drugs are administered in several ways. The
most common are in pill, liquid (oral), skin patch, injection,
suppository and intravenous infusion.
Mass Market Drug:
are drugs that are already on the market. Even after a
drug is approved by the FDA, further studies may be done.
The FDA approves a drug for certain conditions so if the
pharmaceutical company wants to market the drug for other
uses, then additional trials must be done. Also, if a
generic version of a drug is produced, it too must go
through certain trials which compare the generic version to
the actual drug.
drugs are tested with a radioactive element which allows the
drugs to appear better in blood, urine and stool collections.
The radioactive element is
carbon 14 and is given to you in a low dose, usually
in a less dose than environmental radiation. The FDA
regulates how much radiation can be administered to human test
subjects. When you participate in a radio-label drug, you
will take one or more doses of the drug without the radioactive
element and then one dose with the radioactive element. On
this day, you will have multiple blood draws (pk). At this
point, you will stop dosing and start urine, stool and daily
blood collection. Once the clinic has determined that the
drug has been completely excreted from your system via blood,
urine and stool, you will be released from the clinic. The
amount of days you will spend in the clinic will depend on your
body's metabolism. Each radioactive study is different.
The amount of radiation you will receive will vary.
You will see many of these studies as Out-Patient
visits. These can range from testing simple things like
latex gloves to brain imaging scanners.