Results
from clinical trials advance screening and treatment
techniques using a systematic series of steps,
called phases. The results from each phase
informs researchers about the appropriateness of the
new technique. These phases offer patient
protection. Clinical trials come after a long
period of extensive studies in laboratory animals.
Clinical trials consist of three
phases:
Phase I trials: These first studies in
people evaluate how a new drug should be given (by
mouth, injected into the blood, or injected into the
muscle), how often, and what dose is safe. A Phase I
trial usually enrolls only a small number of
patients, sometimes as few as a dozen.
Phase II trials: A phase II trial
continues to test the safety of the drug, and begins
to evaluate how well the new drug works. Phase II
studies usually focus on a particular type of
cancer.
Phase III trials: These studies test a
new drug, a new combination of drugs, or a new
surgical procedure in comparison to the current
standard for treatment. A participant will usually
be assigned to the standard treatment group or the
new treatment group at random (called
randomization). Phase III trials often enroll large
numbers of people and may be conducted at many
doctors' offices, clinics, and cancer centers
nationwide.
The National Cancer Institute
lists the following benefits for participating in a
clinical trial.
- Treatment
studies offer sophisticated, up-to-date, cancer
care. Patients who do not receive the new
treatment receive up-to-date standard care.
- If a new
treatment or prevention approach is successful,
study participants receiving that approach are
the first to benefit.
- Many
people take part in a study to help others who
also have cancer, and they feel good about
making this contribution.
- Exploring
all the treatment and prevention options may
help a person feel more in control and more a
part of vitally important decisions affecting
his or her life.
- Taking
part in a study does not end a continuing
relationship with the participant’s primary
care physician.
Sources:
National Cancer Institute, OncoLink University of
Pennsylvania Cancer Center