ANTIBIOTICS DISCOVERY LAB EXAM #2
QUESTIONS WITH CORRECT ANSWERS
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
the study reviewed by an institutional review board (IRB), and following all the rules
required for studying investigational new drugs.
With whom is the IND filed? - ANSWER-The FDA
Can a patient be given an investigational drug without their knowledge? - ANSWER-At
times, a study may be designed so that patients don't know which one they're getting,
but they know they're getting treatment that at the very least meets the current standard
of care. None of the patients would get only a placebo. Everyone gets standard
treatment if there's a standard treatment available.
Why would a clinical trial be performed on a drug that is already FDA-approved? -
ANSWER-Even after testing a new medicine on thousands of people, the full effects of
the treatment may not be known. Some questions may still need to be answered.
Explain what a placebo control is. - ANSWER-A placebo control group keeps people
from knowing if they're getting the treatment being studied, and makes the results more
likely to be valid.
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
QUESTIONS WITH CORRECT ANSWERS
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
the study reviewed by an institutional review board (IRB), and following all the rules
required for studying investigational new drugs.
With whom is the IND filed? - ANSWER-The FDA
Can a patient be given an investigational drug without their knowledge? - ANSWER-At
times, a study may be designed so that patients don't know which one they're getting,
but they know they're getting treatment that at the very least meets the current standard
of care. None of the patients would get only a placebo. Everyone gets standard
treatment if there's a standard treatment available.
Why would a clinical trial be performed on a drug that is already FDA-approved? -
ANSWER-Even after testing a new medicine on thousands of people, the full effects of
the treatment may not be known. Some questions may still need to be answered.
Explain what a placebo control is. - ANSWER-A placebo control group keeps people
from knowing if they're getting the treatment being studied, and makes the results more
likely to be valid.
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
