| 
If
you are treating a physician who would benefit from any study listed,
you may want to contact the appropriate institution. If you are
an MDS patient, you may wish to discuss a trial with your primary
treating physician to see if you qualify as a candidate.
Clinical trials
study new interventions (drugs or procedures) to evaluate their
safety and effective-ness in humans. Trials follow a careful set
of steps, allowing for the systematic gathering of information to
answer questions and confirm hypotheses that were formed earlier,
in either laboratory experiments or preliminary trials.
A
clinical trial falls into one of four phases:
Phase
I: This is the first time a drug is used in humans. The trial
is designed to determine dosage, route of administration (oral,
intravenous, or by injection), and schedule of administration (how
many times a day or week). In this phase, researchers also begin
to determine the drug's safety. The Phase I trial is normally conducted
in healthy adults and enrolls only a small number of people.
Phase
II: Patients with the disease receive the drug at dose levels
determined in the earlier phase. The Phase II trial begins to determine
the effectiveness of the drug and provides more information about
its safety.
| To submit
information on your clinical trials for publication, you can
fax or e-mail us at the Foundation. Please include a contact
person, a phone number, and if applicable, the trial number.
|
Phase
III: The drug is tested alone or against an approved standard
drug. The typical Phase III trial enrolls a large number of patients.
If it is a comparison trial, patients may be randomly assigned to
receive either the new drug or the standard intervention.
Phase
IV: In Phase IV the drug, already approved by the FDA and
available to the public, undergoes continued evaluation. The Phase
IV designation is rare.
Some trials,
screening trials and studies evaluating supportive care or prevention
are not conducted in phases. In this type of trial, a group following
a certain strategy to combat disease, such as a detection method
or a behavioral change, is compared to a control group.
We would like
to invite you to submit information on your clinical trials for
publication.
Please fax
or e-mail
the information to the Foundation. |
