CLINICAL TRIALS
Clinical trials evaluate the effectiveness and safety of medications by monitoring
their effects on people. Trials are conducted in a series of steps called phases,
each designed to answer a unique research question.
- Phase I: Researchers test a new drug or treatment in a small number of 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 number of people to
see if it is effective and to further evaluate its safety.
- Phase III:The drug or treatment is given to large numbers of people to confirm
its effectiveness, monitor side effects, compare it to commonly used treatments
or placebo, and collect information that will allow the drug or treatment to be
used safely.
- Phase IV:Studies typically conducted after the drug or treatment has been
approved by the FDA to gather information on the drug's effect in various populations
and any side effects associated with long-term use.12
DACOGEN’s
controlled Phase III study included a total of 170 adult patients with myelodysplastic
syndromes. The results showed that DACOGEN® (decitabine) for Injection
plus supportive care was effective2,3 and response rates were superior
to those of supportive care alone.2,3 All patients responding to DACOGEN
became transfusion independent.
For full details and results of the DACOGEN clinical trial, please visit the Clinical Responses page.
In that same randomized, controlled phase III trial, the percentage of MDS patients
achieving red blood cell (RBC) transfusion independence increased with DACOGEN treatment.
Learn more by visiting the
Transfusion Independence page.
References