Sunday, December 30, 2007

General Health Topic - Clinical Research Studies

Hello Everyone,

Are you generally healthy, non smoker, have a little free time and would like to make some extra $$$. If so, you may want to participate in a Clinical Research Study.

In San Antonio, Austin and most major cities around the country, there are Physician Offices, Clinics and Research Companies that are conducting clinical research studies.

Participating in clinical trials is beneficial in many ways. First, that is the way that medications are tested in humans. Secondly, to entice participation in those studies, the pharmaceutical companies sponsoring those trials, pay people who enroll in those studies. That is how people use clinical trials to make some extra money.

Clinical trials are conducted in a series of steps, called phases. Each phase is designed to answer different and separate research questions.

If you are going to participate, it is helpful to know and understand the different phases.

· Phase I: Researchers test a new drug or treatment in a small group of healthy people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

· Phase II: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.

· Phase III: The drug or treatment is given to large groups of people to confirm its effectiveness, (usually the study subjects have the condition the medication is intended to treat) monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

· Phase IV: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

There are other types of studies that are conducted. One of the other types of study is bio-equivalence studies. In those studies, a generic drug manufacturer is trying to prove that their generic formulation is the same as the brand name product.

Additional Resource Information on clinical trials can be found at

Many of the Clinical Research Companies like CEDRA or PPD conduct phase I trials. If you decide to participate in one of the phase I trials, there are some things that should be considered.
Length of Study

How many inpatient visits and how long is each inpatient stay.

How many blood draws will there be.

How many out patient visits are there.

How frequent are the follow-up visits.

Do you mind being stuck with a needle for frequent (very frequent) blood draws.

Can you swallow pills, tablets and capsules. (There are many subjects that enrolled in a trial and at the time of dosing, they admit that they cannot swallow tablets. That is a huge waste of time for the patient and the investigating company. It is also a large expense for the investigating company and the loss of income for a person that could not participate due to the study being full.)

What type of drug is being investigated.

Are you a picky eater. (Many studies require that all the subjects eat the same meals. You are expected to eat everything that is put in front of you in a specified time. Usually, there is no menu selection available. You eat what is provided.)

For more information on clinical research companies and to get an idea what trials are available, please check out:

Good Luck,

Dr. Paul

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