CUI -- UBA Examen de Nivel 6 de Curso Basico (relaizado junio –dic.

2008)

1. EJER 1 - 2º SES - N 6 CB (ING) [PUNTAJE = 20]

Read the following text

An Introduction to Clinical Trials

The University of Texas M. D. Anderson Cancer Center

A clinical trial is a strictly monitored process by which new treatments are tested
on human subjects in a hospital or clinical setting. The safety of study participants
is our top priority!

Clinical trials at M. D. Anderson involving humans must first be approved by an

Institutional Review Board, which includes doctors, administrators, ethicists and
members of the general public. Volunteers are fully informed of possible risks and
sign a consent form before being accepted into a clinical trial. Results of clinical
trials that prove a new treatment to be safe and effective are reviewed by the U.S.
Food and Drug Administration, which determines if and when it can be marketed
for use by all patients with that particular disease.

Clinical trials have four distinct phases:

Phase One trials use a small number of human subjects to test a new treatment
that has already undergone rigorous testing in animals. Participants usually have
advanced cancer that has not responded to standard treatments. At this stage,
researchers can only predict outcomes and any possible side effects on humans.
During Phase One trials, investigators determine the most effective dosage and
application methods. Some cancer patients have seen improvement in this phase.

Phase Two trials involve a larger group of patients, in which researchers build on
what they have learned in Phase One. Because more subjects are involved,
investigators may discover less common side effects, and will continue to evaluate
the safety of the treatment.

Phase Three trials may involve over a thousand patients, often at several medical
institutions. During this phase, the study treatment is compared to and /or
combined with standard modalities (treatment methods) . Some participants, the
“treatment group” are given the experimental treatment and others in a “control
group” are given the current standard treatment, so researchers can compare
outcomes in the two groups.

Phase Four trials occur after the treatment has been put in the market to monitor
effects of long-term usage, and how it affects certain population groups. If
dangerous side effects are found, the drug or treatment is taken off the market.

Before enrolling in a clinical trial, you will undergo the informed consent process. At
this time, the investigator will explain the purpose of the trial, its expected
benefits, any possible risks or side effects, and what your role will be. This is the
time to ask questions! If you want to join the trial you must sign the informed
consent documents. You can leave a clinical trial at any time without penalty, even
after signing the consent forms.

CHOOSE THE BEST OPTION

1. The relative pronoun “which” in the first paragraph (line 1) refers to:

new treatments
a strictly monitored process
research doctors
2. The relative pronoun “which” in the second paragraph (line 4 ) refers
to:

an Institutional Review Board

a hospital or clinical setting
M.D. Anderson Cancer Center
3. Who decides whether a new treatment for cancer can be marketed?

Doctors, administrators, ethicists and members of the general public.

The U.S. Food and Drug Administration.
All patients with that disease.
4. The word “rigorous” in the third paragraph (line 11 ) means:

complex and painful

severe
thorough and exact
5. If the number of subjects involved during Phase Two trials were
smaller,...

...investigators wouldn’t be able to discover less common side effects.

...researchers would discover more common side effects.
...investigators would not be able to determine the most effective dosage.
6. Which of the following statements is NOT true?

The study treatment at Phase Three may be combined with standard modalities.
All patients involved in clinical trials at Phase Three are seen at M. D. Anderson.
Phase Four takes place once that the new treatment has been put on the market.
7. The time to ask questions is....

... after participants have signed the consent documents.

... during the informed consent process.
... before enrolling in a clinical trial..
8. The information in this text is meant for:

prospect cancer study participants

students of medicine
cancer researchers