ANTIBIOTICS DISCOVERY LAB EXAM #2
QUESTIONS WITH CORRECT ANSWERS
Phase III: - ANSWER-Phase III clinical trials compare the safety and effectiveness of
the new treatment against the current standard treatment. Most phase III clinical trials
have a large number of patients, at least several hundred. These studies are often done
in many places across the country (or even around the world) at the same time. Phase
III clinical trials are more likely to be offered by community-based doctor's offices. These
studies tend to last longer than phase I and II studies. Placebos may be used in some
phase III studies, but they're never used alone if there's a treatment available that
works. Participants get either the standard treatment or the new treatment. When
possible, neither the doctor nor the patient knows which of the treatments the patient is
getting.
Phase IV: - ANSWER-Phase IV: Phase IV studies look at drugs that have already been
approved by the FDA. The drugs are available for doctors to prescribe to patients, but
phase IV studies might still be needed to answer important questions. These studies
may involve thousands of people. This is typically the safest type of clinical trial because
the treatment has already been studied a lot and might have already been used in many
people. Phase IV studies look at safety over time. These studies may also look at other
aspects of the treatment, such as quality of life or cost effectiveness.
Randomization: - ANSWER-the arrangement of a set of items, people, etc. in an
unpredictable, unsystematic, or random order.
Double-blind study: - ANSWER-Participants get either the standard treatment or the
new treatment. When possible, neither the doctor nor the patient knows which of the
treatments the patient is getting.
NDA: - ANSWER-In the United States, when phase III clinical trials (or sometimes
phase II studies) show a new drug is more effective and/or safer than the current
standard treatment, a new drug application (NDA) is submitted to the FDA for approval.
The FDA then reviews the results from the clinical trials and other relevant information.
If approved, the new treatment often becomes a standard of care, and newer drugs
must often be tested against it before being approved.
Beneficence: - ANSWER-Protecting people from harm by maximizing benefits and
minimizing risks
What two types of treatments are tested in clinical trials? - ANSWER-standard treatment
and new treatment
Explain the two major aims of clinical trials. - ANSWER-Does the new treatment work in
humans? If it does, doctors are also looking at how well it works. Is it better than what's
, now being used to treat a certain disease? If it's not better, is it at least as good, while
perhaps causing fewer side effects? Or does it work in some people who aren't helped
by current treatments?
Is the new treatment safe? No treatment or procedure - even one already in common
use - is entirely without risk. But do the benefits of the new treatment outweigh the
possible risks?
Draw a timeline of drug development from preclinical testing to FDA approval. -
ANSWER-
What is the biggest barrier to the success of clinical trials? - ANSWER-Not enough
people take part in them
What patient population is most likely to be enrolled in clinical trials? - ANSWER-
Why are childhood disease among the most successfully treated diseases in terms of
clinical trials? - ANSWER-Clinical trials are much more commonly used to treat children
with cancer. In fact, 60% of children with cancer under age 15 participate in clinical
trials.
What information must be obtained before testing in patients? - ANSWER-Whether it's
ethical to ask patients to volunteer for the experimental treatment. Has the study been
designed, as much as possible, to make sure the people in it will be safe? Will the
volunteers get a treatment that's at least as good as, and maybe even better than, what
they would get if they didn't volunteer for the study?
Is animal testing required to move a proposed drug to clinical trials? - ANSWER-Cell
studies and animal testing are included in preclinical studies, but animal testing is not
required. It is more difficult to meet the safety requirements for entry to clinical trials.
What information is required for the Investigational New Drug application - ANSWER-
Pre-clinical studies: Results from studies, including those on animals, allow the FDA to
decide whether the product is reasonably safe for testing in humans. This part may also
include any experience with the drug in humans (if the drug has been used or studied in
another country, for example).
Manufacturing information: This explains how the drug is made, who makes it, what's in
it, how stable it is, and more about the physical qualities of the drug. The FDA uses this
information to decide whether the company can make batches of the drug that will
always be exactly the same.
Clinical protocols and investigator information: Detailed outlines for the planned clinical
studies, called study protocols, are looked at to see if the study might expose subjects
to unnecessary risks. Information on the clinical investigators who will supervise the
study is reviewed to find out if they're qualified to run clinical trials. Finally, the research
sponsor must commit to getting informed consent from the research subjects, having
QUESTIONS WITH CORRECT ANSWERS
Phase III: - ANSWER-Phase III clinical trials compare the safety and effectiveness of
the new treatment against the current standard treatment. Most phase III clinical trials
have a large number of patients, at least several hundred. These studies are often done
in many places across the country (or even around the world) at the same time. Phase
III clinical trials are more likely to be offered by community-based doctor's offices. These
studies tend to last longer than phase I and II studies. Placebos may be used in some
phase III studies, but they're never used alone if there's a treatment available that
works. Participants get either the standard treatment or the new treatment. When
possible, neither the doctor nor the patient knows which of the treatments the patient is
getting.
Phase IV: - ANSWER-Phase IV: Phase IV studies look at drugs that have already been
approved by the FDA. The drugs are available for doctors to prescribe to patients, but
phase IV studies might still be needed to answer important questions. These studies
may involve thousands of people. This is typically the safest type of clinical trial because
the treatment has already been studied a lot and might have already been used in many
people. Phase IV studies look at safety over time. These studies may also look at other
aspects of the treatment, such as quality of life or cost effectiveness.
Randomization: - ANSWER-the arrangement of a set of items, people, etc. in an
unpredictable, unsystematic, or random order.
Double-blind study: - ANSWER-Participants get either the standard treatment or the
new treatment. When possible, neither the doctor nor the patient knows which of the
treatments the patient is getting.
NDA: - ANSWER-In the United States, when phase III clinical trials (or sometimes
phase II studies) show a new drug is more effective and/or safer than the current
standard treatment, a new drug application (NDA) is submitted to the FDA for approval.
The FDA then reviews the results from the clinical trials and other relevant information.
If approved, the new treatment often becomes a standard of care, and newer drugs
must often be tested against it before being approved.
Beneficence: - ANSWER-Protecting people from harm by maximizing benefits and
minimizing risks
What two types of treatments are tested in clinical trials? - ANSWER-standard treatment
and new treatment
Explain the two major aims of clinical trials. - ANSWER-Does the new treatment work in
humans? If it does, doctors are also looking at how well it works. Is it better than what's
, now being used to treat a certain disease? If it's not better, is it at least as good, while
perhaps causing fewer side effects? Or does it work in some people who aren't helped
by current treatments?
Is the new treatment safe? No treatment or procedure - even one already in common
use - is entirely without risk. But do the benefits of the new treatment outweigh the
possible risks?
Draw a timeline of drug development from preclinical testing to FDA approval. -
ANSWER-
What is the biggest barrier to the success of clinical trials? - ANSWER-Not enough
people take part in them
What patient population is most likely to be enrolled in clinical trials? - ANSWER-
Why are childhood disease among the most successfully treated diseases in terms of
clinical trials? - ANSWER-Clinical trials are much more commonly used to treat children
with cancer. In fact, 60% of children with cancer under age 15 participate in clinical
trials.
What information must be obtained before testing in patients? - ANSWER-Whether it's
ethical to ask patients to volunteer for the experimental treatment. Has the study been
designed, as much as possible, to make sure the people in it will be safe? Will the
volunteers get a treatment that's at least as good as, and maybe even better than, what
they would get if they didn't volunteer for the study?
Is animal testing required to move a proposed drug to clinical trials? - ANSWER-Cell
studies and animal testing are included in preclinical studies, but animal testing is not
required. It is more difficult to meet the safety requirements for entry to clinical trials.
What information is required for the Investigational New Drug application - ANSWER-
Pre-clinical studies: Results from studies, including those on animals, allow the FDA to
decide whether the product is reasonably safe for testing in humans. This part may also
include any experience with the drug in humans (if the drug has been used or studied in
another country, for example).
Manufacturing information: This explains how the drug is made, who makes it, what's in
it, how stable it is, and more about the physical qualities of the drug. The FDA uses this
information to decide whether the company can make batches of the drug that will
always be exactly the same.
Clinical protocols and investigator information: Detailed outlines for the planned clinical
studies, called study protocols, are looked at to see if the study might expose subjects
to unnecessary risks. Information on the clinical investigators who will supervise the
study is reviewed to find out if they're qualified to run clinical trials. Finally, the research
sponsor must commit to getting informed consent from the research subjects, having
