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Investigational Drug Flashcards

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1
Q

Any experiment in which a drug is
administered or dispensed to one or more
human subjects.

A

Clinical
Investigation

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2
Q

A drug, antibiotic, or biologic that is used in
a clinical investigation.

A

Investigational
New Drug (IND)

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3
Q

The label of an
investigational drug must bear the
statement:

A

“Caution: New Drug—Limited
by Federal (or U.S.) law to investigational
use.”

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4
Q

IND application is a submission to the FDA containing

A

chemical information, preclinical data, and a detailed description of the planned clinical
trials

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5
Q

An IND for which the sponsor is usually
either a corporate entity or one of the
institutes of the National Institutes of Health
(NIH).

A

Commercial IND

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6
Q

Strictly for research purposes, done to prove
a theory, improve an existing treatment
institutes/academe

A

Research IND

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7
Q

The individual responsible for initiating the

clinical trial at the study site.

A

Investigator

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8
Q

An individual who participates in a clinical
investigation (either as the recipient of the
investigational drug or as a member of the
control group).

A

Subject

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9
Q

A standard for the design, conduct,
monitoring, analyses, and reporting of
clinical trials that provides assurance that
the results are credible and accurate, and
that the rights of study subjects are
protected

A

Good Clinical
Practice (GCP)

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10
Q

A committee of reviewers that is responsible
for ensuring the protection of the rights,
safety, and well-being of human subjects
involved in a clinical investigation.

A

Institutional
Review Board
(IRB)/Institutiona
l Ethics
Committee (IEC)

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11
Q

First major attempt of drug regulation

A

Import Drug Act of 1848

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12
Q

provided for the inspection, detention and
destruction or reexport of imported drug
shipments that failed to meet standards

A

Import Drug Act of 1848

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13
Q

drugs not to be mislabeled or adulterated and
must meet recognized standards for strength
and purity.

A

Pure Food and Drugs Act (1906)

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14
Q

safety of drugs, and be proven through testing
before they can be marketed

A

Food, Drug and Cosmetic Act of 1938

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15
Q

when was Food, Drug and Cosmetic Act of 1938 created

A

June 25,1938

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16
Q

creation of OTC and Rx drugs

A

Durham and-Humphrey Amendment

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17
Q

Authorized that prescriptions can be refilled

A

Durham and-Humphrey Amendment

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18
Q

Caution: Federal law prohibits dispensing
without prescription

A

Durham and-Humphrey Amendment

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19
Q

manufacturer had to demonstrate efficacy, and
safety of drug prior to marketing (because of
phocomelia secondary to Thalidomide)

A

Kefauver-Harris Drug Amendment

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20
Q

medication used to
treat motion sickness usually taken by
pregnant women, has a side effect of
teratogenic effect on infants

A

Thalidomide strategy

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21
Q

decides which drugs, biologics, and medical
devices are safe and efficacious and therefore
can be marketed.

A

FDA

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22
Q

FDA reviews priority drugs in _________ and
standard drugs within ___________

A

six (6) months; ten (10) months

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23
Q

antibiotics, cancer drugs, rx
drugs

A

Priority drugs

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24
Q

otc drugs

A

Standard drugs

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25
developed a web-based system that offers information about ongoing clinical trials for a wide range of diseases and conditions.
National Institute of Health (NIH)
26
agencies involved in the transparency and harmonisation of drug development
- National Institute of Health (NIH) - International Conference on Harmonization (ICH)
27
Search for studies for particular diseases and identify treatment centers that offer enrollment into these studies.
National Institute of Health (NIH)
28
for the regulatory requirements for drug approval
International Conference on Harmonization (ICH)
29
provide methods to ensure simultaneous submission and rapid regulatory approval in the world’s largest markets
International Conference on Harmonization (ICH)
30
Minimize duplication of effort, improve efficiency, increase quality and efficiency of medical treatments worldwide
International Conference on Harmonization (ICH)
31
PROTECTION OF HUMAN SUBJECTS
- Nuremberg Code - Declaration of Helsinki (1964) - Belmont Report (1978) - Code of Federal Regulations (CFR)
32
judge the human experimentation conducted by the Nazis in the middle of the twentieth century
Nuremberg Code
33
According to Nuremberg Code “__________ consent of the human subjects is absolutely essential”
voluntary
34
10 point statement/quotes which limits permissible medical experimentation on human subjects
consent
35
re-emphasized protection of human subjects
Declaration of Helsinki (1964)
36
Developed by WMA (world medical Association)
Declaration of Helsinki (1964)
37
Respect for individuals
Declaration of Helsinki (1964)
38
Right to be informed on decisions
Declaration of Helsinki (1964)
39
Recognition on Vulnerable groups
Declaration of Helsinki (1964)
40
basic ethical principles underlying medical research on human subjects
Belmont Report (1978)
41
Ethical principles involved in belmont report
- Respect - Justice - beneficence
42
designed to make the protection of human subjects in all federal agencies uniform
Code of Federal Regulations (CFR)
42
The drug approval process in the United States is standardized by FDA review
DRUG APPROVAL PROCESS
43
testing conducted either in vitro or in animals. (harmful effects)
Preclinical testing
44
Before filing an IND, the sponsor must have developed a ___________ of the drug, determined its acute and subacute toxicity, and have sufficient information regarding chronic toxicity to support the drug's use in humans
pharmacologic profile
45
Before filing an IND, the sponsor must have developed a pharmacologic profile of the drug, determined its ___________ toxicity, and have sufficient information regarding ___________ to support the drug's use in humans
acute and subacute; chronic toxicity
46
INVESTIGATIONAL NEW DRUG APPLICATION (IND) is done before or after pre-clinical testing?
Done after pre-clinical testing
47
the application by the study sponsor (eg. pharmaceutical company, individual investigator as sponsor-investigator) to the FDA to begin clinical trials in humans.
IND
48
Tests are reviewed by
FDA
49
T/F: Informed consent is included in IND
T
50
when will IND be not required
- drug is marketed in the USA - Study is not reported to the FDA in support of a new indication - Study does not involve a different dose, route, patient population that increase risk to patients - IRB approval and informed consent are secured - Study will not be used to promote drug’s effectiveness for a new indication
51
INVESTIGATIONAL NEW DRUG (IND) APPLICATION inclusions
- Cover Sheet (Form 1571) - Table of Contents - Introductory statement - General Investigational Plan - Investigator’s brochure - Clinical protocol - Chemistry, manufacturing and control data - Pharmacology and toxicology data - Previous human experience - Additional information
52
Four types of documents that may be used to amend the IND
- Protocol amendments - Information amendments - IND Safety Reports - Annual Reports
53
Submitted when a sponsor wants to change a previously submitted protocol or add a new study protocol to an existing IND
Protocol amendments
54
Submitted when information becomes available that would not be presented using a protocol amendment, IND safety report, or annual report (e.g., new chemistry data).
Information amendments
55
reports clinical and animal adverse reactions; reporting requirements depend on the nature, severity, and frequency of the experience.
IND Safety Reports
56
describe the progress of the investigation including information on the individual studies, summary information of the IND (summary of adverse experiences, IND safety reports, preclinical studies completed in the last year)
Annual Reports
57
Suspected adverse reaction: An adverse reaction for which there is evidence to suggest a causal relationship between the drug and the adverse event.
IND Safety Report
58
An event that results in any of the following outcomes: death, a life-threatening adverse drug experience, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect.
Serious adverse event or serious suspected adverse reaction:
59
in IND Safety Report, FDA must be notified within __________ calendar days
15 calendar days
60
An adverse reaction that is not listed in the current labeling for the drug product.
Unexpected adverse event or unexpected suspected adverse reaction:
61
Once submitted to the FDA, the IND will be forwarded to the appropriate review division based on the __________ of the product.
therapeutic category
62
the IND and clinical trial will be assigned to a review team that includes:
- project manager - chemistry, manufacturing, and controls (CMC) reviewer - nonclinical pharmacology/toxicology reviewer - clinical reviewer,
63
The FDA has _______ days after receipt of an IND to respond to the sponsor.
30
64
First use of the agent in humans
PHASE I
65
Usually treat 20-80 patients (healthy volunteers)
PHASE I
66
Used to determine the safety and toxicity of the agent
PHASE I
67
Evaluation of the effect of the drug on a subject who does not have any pre-existing conditions
PHASE I
68
PHASE I last an average of ________
six months to one year
69
Small number of subjects who suffer from the disease or condition that the drug is proposed to treat
PHASE II
70
Used to evaluate the efficacy of the agent.
PHASE II
71
Usually treat between 100-200 patients
Phase II
72
Phase II duration
2 years
73
Used to further define the efficacy and safety of the agent
PHASE III
74
Comparison of the new agent is compared to current therapy
PHASE III
75
Usually multicenter studies
PHASE III
76
Usually treat hundred to 3,000 patients
PHASE III
77
Lasts about three years
PHASE III
78
Considered “pivotal studies” basis for new drug application product’s marketing approval
PHASE III
79
the study of variations of DNA and RNA characteristics as related to drug response including effectiveness and adverse effects
PHASE III
80
phase wherein pharmacogenomics is already included
Pharmacogenomics
81
impact of a certain genotype or phenotype relative to response or adverse events
PHASE III
82
NEW DRUG APPLICATION (NDA) is done after
Phase III trials
83
Within ________ days, FDA will review the application (NDA) and send the applicant an approval letter or complete response letter
180
84
Allows investigational drugs to be used for treatment use in patients with serious or life-threatening diseases where there is no other comparable or satisfactory alternative therapy.
EXPANDED ACCESS TO INVESTIGATIONAL DRUGS FOR TREATMENT USE
85
those associated with morbidity that has substantial impact on day-to-day functioning
Serious conditions
86
Authorization from FDA to charge for an IND in the following conditions:
○ drug has a potential benefit ○ drug is effective/safe ○ RCT could not be conducted without charging because the cost of the drug is extraordinary to the sponsor.
87
In priority review drug will potentially a significant advance in medical care and sets a target to review the drug within________ instead of the standard ten (10) months
six (6) months
88
Drugs can treat unmet medical needs.
Fast Track Review
89
Allows for early approval of a drug for serious or life-threatening illness that offers a benefit over current treatments.
Accelerated Approval Program
90
allows for expedited development and review of drugs which are intended to treat serious conditions and which may demonstrate substantial improvement over available therapy
Breakthrough Therapy
91
EXPEDITED REVIEW OF DRUGS
Priority Review Fast Track Review Accelerated Approval Program Breakthrough Therapy
92
Aka postmarketing studies after drug approval
PHASE IV
93
Utilized by FDA when they determine that safety measures are needed beyond the labeling to ensure that a drug’s benefits outweigh its risks
RISK EVALUATION AND MITIGATION STRATEGIES (REMS)
94
size and population likely to use the drug, seriousness of disease, expected benefits, expected duration of treatment, seriousness of events (known or potential), whether drugs is an NME.
Factors to consider in determining the need for REMS:
95
REMS must be assessed for adequacy at least by
18 months, 3 years and 7 years after approval
96
used for treatment of a rare disease, affecting fewer than 200,000 people in the USA, or one that will not regenerate enough revenue to justify the cost of research and development
THE ORPHAN DRUG ACT
97
Committee formed to review proposed clinical trials and the progress of such studies to ensure that the rights and welfare of human subjects are protected.
INSTITUTIONAL REVIEW BOARD/INSTITUTIONAL ETHICS COMMITTEE (IEC)
98
liaison between IRB and the sponsor
Principal Investigator (PI)
99
After clinical trial, records must be maintained:
○ 2 years after approval of the NDA or ○ 2 years after FDA received notification that investigation was discontinued.
100
only individual who is not aware of what the patient is receiving is the patient him or herself.
Single-blind study
101
the nurse, physician, and patient are all unaware of what the patient is receiving.
Double-blind study
102
when the drug that arrives at the pharmacy is already blinded.
Triple-blind study
103

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