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Biology > Clinical Trials and Quality Assurance > Flashcards

Clinical Trials and Quality Assurance Flashcards

1
Q

What is a clinical trial?

A

Biomedical or health-related scientific experiment designed to answer specific question(s)

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2
Q

What is the difference between a clinical trial and a clinical study?

A

Clinical trials are prospective whereas clinical studies can be both prospective and retrospective

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3
Q

What are some study designs?

A

Experimental (interventional):
Semi-experimental
Observational (non-interventional)

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4
Q

What is an experimental study?

A

Evaluates efficacy (explanatory) and effectiveness (pragmatic) of a therapeutic or treatment

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5
Q

What is a semi-experimental study?

A

Trials with historical controls

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6
Q

What is an observational study?

A

Subjects observed and specific outcomes measured without any active intervention of the subjects’ medical care
No experiment is being performed

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7
Q

What are some types of experimental clinical trials?

A

Diagnostic
Screening
Quality of Life

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8
Q

What is a diagnostic clinical trial?

A

Evaluates the ability of a test or procedure to correctly diagnose a disease or medical condition or to measure a specific parameter

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9
Q

What is a screening clinical trial?

A

Tests the best way to detect certain diseases or health conditions

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10
Q

What is a quality of life clinical trial?

A

Measure effect on quality of life or changes in behaviors or lifestyle factors

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11
Q

What is the difference between efficacy and effectiveness?

A 
Efficacy = explanatory
Effectiveness = pragmatic
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12
Q

What is efficacy?

A

Measure product’s ability to treat the indicated condition

Tests whether the product produces the desired clinical outcome under research (or optimal) conditions

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13
Q

What is effectiveness?

A

Measure of how well the drug or device works; includes efficacy as well as the tolerability and ease of use of the product
Focuses on whether an intervention or procedure works under usual conditions or actual practice

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14
Q

Why are interventional clinical trials needed?

A

Definitive method and provides sounder rationale for determining an intervention’s effect
Helps determine incidence of AE or complications of intervention
Clinical practice influence

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15
Q

What are some types of interventions?

A 
Single/individual treatment/therapy
Exposure (i.e. radiotherapy)
Medical device
Surgical technique
Combination treatment
Educational or behavioral program
Dietary change
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16
Q

What is clinical research? What of the individual subject?

A

Goal: to test a hypothesis and generate knowledge to improve medical care or public health; serve the common good
Individual subject may or may not benefit from participation

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17
Q

What is clinical practice? What of the individual subject?

A

Goal: diagnose, provide preventative care, or treat illness or medical condition in a particular individual(s) with reasonable expectation of success
Care provided to enhance individual patient’s well-being

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18
Q

T/F: High quality care and treatment for the patient is the goal of clinical research?

A

F

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19
Q

When was the concept of blindness introduced and by whom?

A

1931

Amberson via flip of a coin as a form of random treatment group assignment

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20
Q

When was the importance of controlled experiments emphasized and by whom?

A

1930

Sollman

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21
Q

When was the Nuremberg Code created and in reaction to which event?

A

1949

to the Nazi human experimentations

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22
Q

When was the Federal Food, Drug, and Cosmetic Act and what did it entail?

A

1962

required informed consent and that subjects be told if the drug is investigational

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23
Q

When was the Declaration of Helsinki and what did it entail?

A

1964

stressed importance of assessing risks vs potential benefits of clinical research

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24
Q

What is IRB and when was it established?

A

Institutional Review Board: reviews all clinical research performed under Public Health Service grants
1966

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25
Q

What is a benefit to clinical research?

A

Enables advances in medical practice and healthcare that otherwise would not be possible

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26
Q

What are some limits to clinical research?

A

Rigorous conduct required to avoid false results could cause harm
Individual subjects may or may not benefit
Opportunity for exploitation when subjects are exposed to potential risks for benefit of others/society

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27
Q

What are some historical violations of human rights?

A

Nazi War Crimes
Brooklyn Jewish Chronic Disease Hospital (1963)
Hepatitis B study at Willowbrook
Tuskegee syphilis study (1932-1972)

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28
Q

What documents have helped shape the current ethical framework for human research studies conduct?

A

Nuremberg Code
Declaration of Helsinki
Belmont Report

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29
Q

When was the Declaration of Helsinki established and what did it entail?

A

1964

Recommendations to be used as an ethical code by all medical doctors conducting biomedical research

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30
Q

When was the Belmont Report established and what did it entail?

A

1979

Emphasizes need to protect human subjects from exploitation and harm

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31
Q

What are the basic ethical principles that guide the conduct of research?

A

Respect for persons
Beneficence
Justice

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32
Q

What is respect for persons?

A

Individuals should be treated as autonomous

Some persons are in need of protection (and may even need to be excluded from potential harm)

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33
Q

What is beneficence?

A

Study has social/scientific value, scientific validity, and favorable risk/benefit ratio
Do not harm
Maximize potential benefits and minimize potential harms

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34
Q

What is justice?

A

Recruitment and selection of subjects is fair and inclusion/exclusion criteria are reasonable
Selection should not be based on easy availability, compromised position, manipulability

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35
Q

What elements does informed consent contain?

A

Information
Comprehension
Voluntariness

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36
Q

What is the ethical framework for clinical research?

A 
Value
Validity
Fair subject selection
Favorable risk-benefit ratio
Independent review
Informed consent
Respect for enrolled participants
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37
Q

Who is the end customer?

A

Patient

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38
Q

What is the purpose of a clinical trial?

A

Assess safety and efficacy/effectiveness
Develop package insert or instructions/directions for use
Enable safe and effective use of the product by HCP and/or patient

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39
Q

What is the FDA mission?

A

Protect and promote public health through safety, efficacy, and security of products regulated

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40
Q

What is the FDA’s definition of a drug?

A

An article intended for use in the diagnosis, cure, mitigation, treatment, or prevention of a disease
An article intended to affect the structure or any function of the body

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41
Q

What is the FDA’s definition of a biologic?

A

Virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, or analogous product, or rasphenamine or derivative of arsphenamine, applicable to the prevention, treatment, or cure of a disease or condition of human beings

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42
Q

What is the FDA’s definition of a medical device?

A

Instrument, apparatus, implement, machine, implant, in vitro reagent which is intended for use in diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, or which is intended to affect the structure or function of the body

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43
Q

What is the FDA’s definition of a combination product?

A

Product comprised of two or more regulated components that are physically, chemically, or otherwise combined or mixed and produced as a single entity
Two or more separate products packaged together in a single package or as a unit and comprised of drug and device products, device and biological products, or biological and drug products

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44
Q

What is CDER?

A

Center for Drug Evaluation and Research

Regulates new molecular entities (NMEs)/chemically synthesized drugs

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45
Q

What is CDRH?

A

Center for Devices and Radiological Health

Regulates manufacturing, performance, and safety of medical devices and radiation-emitting products

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46
Q

What are the classes of medical devices?

A

Class 1, 2, and 3

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47
Q

What is a class 1 device?

A

Everyday items which are unlikely to cause serious consequence if they fail

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48
Q

What is a class 2 device?

A

“Medium risk” such as demineralized bone powder

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49
Q

What is a class 3 device?

A

Products which would cause obvious risk of injury or death if they don’t function properly
Require pre-market approval (PMA)

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50
Q

What is CFR and which pertains to drugs?

A

Code of Federal Regulations

Title 21

51
Q

What are guidance documents?

A

Describe the FDA’s current thinking on, interpretation of, or policy on, a regulatory issue
Intended to help the “public” understand and comply with regulations and laws

52
Q

T/F: Guidance documents are legally binding.

A

F

53
Q

What is 21 CFR 312?

A

Investigational new drugs regulations

54
Q

What is 21 CFR 3?

A

Definition of primary mode of action of a combination product

55
Q

What is 21 CFR 50?

A

Protection of human subjects

Informed consent

56
Q

What is 21 CFR 56?

A

Institutional review boards

57
Q

What is 21 CFR 58?

A

Good laboratory practice (GLP) for non-clinical lab studies

58
Q

What is 21 CFR 314?

A

New drug applications

59
Q

What is 21 CFR 601?

A

Biologics license applications regulations

60
Q

What is 21 CFR 54?

A

Financial disclosures by clinical investigators

61
Q

What is 21 CFR 25?

A

Environmental impact considerations

62
Q

What is 21 CFR 201 and 202?

A

Labeling and advertising

63
Q

What is 21 CFR 210 and 211?

A

Current good manufacturing practices (cGMP)

64
Q

What is 21 CFR 807?

A

Establishment, registration, and device listing for manufacturers and initial importers of devices

65
Q

What is 21 CFR 1270 and 1271?

A

Human tissues

66
Q

What is a regulated environment?

A

Controlled environment where decisions made and operations performed are based a on predefined set of criteria

67
Q

What are the program building blocks?

A

Chemistry, manufacturing, and controls (CMC)
Nonclinical/preclinical
Clinical (Protocol)

68
Q

What is an IND?

A

Request for authorization from FDA to administer investigational drug or biologic to humans
Exemption to transport product across state lines for clinical investigation

69
Q

When is an IND required?

A

When an approved drug/biologic is used in a clinical investigation
Clinical investigation is for approved drug but new indication

70
Q

When is an IND not required?

A

Product is approved for medical practice
Investigation does not involve route of administration, dosage level, or use that significantly increases risk and conducted in accordance to IRB and informed consent requirements

71
Q

What if a study is performed outside of the US with an IND?

A

Test article can be exported from US

Study must conform to US IND regulations

72
Q

What if a study is performed outside of the US without an IND?

A

May be accepted for FDA review in support of a marketing application
Export of the test articl from the US must conform to FDA regulations

73
Q

What is a pre-IND meeting?

A

Meeting held with FDA before submission of IND
Intended to help ensure all documents are adequately prepared before submission
Not intended as a data review or negotiation meeting

74
Q

T/F: having a pre-IND meeting does not guarantee safety from a clinical hold?

A

T

75
Q

What is a clinical hold?

A

Legal order to delay or stop the study

76
Q

What may lead to a clinical hold?

A

Exposure of subjects to unreasonable risk
Investigator brochure is misleading, erroneous or materially incomplete
Protocol design is inadequate or problematic
Investigator is not qualified

77
Q

What are some regulatory filing strategies?

A 
Accelerated approval
Fast-track/expedited review
Rolling/modular submission
Priority review
Special protocol assessment
78
Q

What is accelerated approval?

A

Specializd program to enable promising therapies for serious or life-threatening conditions and that fill unmet medical need to reach the market faster
Contains “surrogate” endpoints or clinical endpoints that can be measured earlier than an effect on irreversible morbidity or mortality

79
Q

What is fast track review?

A

Facilitates development and expedites review of drugs and biologics intended to treat serious or life-threatening conditions and demonstrates potential to address unmet medical needs

80
Q

What are some special protocols?

A

Animal carcinogenicity
Final product stability
Phase 3 clinical trials that will form the primary basis for an efficacy claim

81
Q

What is the biologics equivalent of a NDA?

A

Biologics license application (BLA)

82
Q

What is the NDA approved by?

A

Federal food, drug, and cosmetic act (FDCnA)

83
Q

What is the BLA approved by?

A

Public health service act (PHSA) and specific sections of the FDCnA

84
Q

What is BIMO?

A

Bioresearch monitoring program

85
Q

What is GLP and when was it established?

A

1979
Regulations addressed process not science of preclinical safety studies
Required good recordkeeping and collection of toxicological and pharmacological data

86
Q

What is GCP?

A

Good clinical practice
International ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve human subjects

87
Q

What are the GCP objectives?

A

Protect safety, well-being and privacy of human subjects

Data integrity

88
Q

What is 21 CFR 11?

A

Electronic records and signatures

89
Q

What is 21 CFR 812?

A

Investigational device exemptions

90
Q

What is 21 CFR 814?

A

Premarket approval of medical devices

91
Q

What is the medical device equivalent of IND?

A

Investigational device exemptions (IDE)

92
Q

What is ICH?

A

International conference on harmonization

93
Q

What is the ICH guideline for GCP?

A

Provide unified standard for EU, Japan, and US to facilitate mutual acceptance of clinical data

94
Q

What are the GCP practice tenets?

A

Rights, safety, and well-being of trial subjects should prevail over interest of science and society
Clinical RnD activities must be conducted within the context of an established plan
Clinical RnD tasks must be conducted according to written standardized procedures
Clinical RnD systems and procedures must be tested by conducting planned reviews and audits to ensure validity of data and compliance with applicable requirements

95
Q

What is SOPs?

A

Standard operating procedures

Standardization of terms and definitions, documentation, and research activities

96
Q

What is quality control?

A

Operational techniques and activities within quality assurance system to verify that requirements for quality of trial-related activities have been fulfilled

97
Q

What is quality assurance?

A

Planned and systematic actions established to ensure that the trial is performed and data is generated, documented, and reported in compliance with GCP and applicable regulatory requirements

98
Q

What main categories make up ICH-GCP principles?

A 
Ethics
Protocol and science
Responsibilities
Informed Consent
Data quality and integrity
Investigational products
Quality control and assurance
99
Q

What does an investigator’s brochure contain?

A 
Description of investigational product
Rationale for research
Physical, chemical, and pharmaceutical properties and formulation
Non-clinical studies
Effects in humans
100
Q

What is a clinical protocol?

A

Detailed step by step description of how the study must be conducted

101
Q

What are the key components of a protocol?

A

Synopsis
Background info
Objectives
Subject selection and conditions for withdrawal
Treatment of subjects
method of subject assignment to treatment groups
Efficacy (drugs) or effectiveness (devices) and/or safety statements

102
Q

What is an open trial design?

A

Investigator(s) and subjects are aware of the treatment assignment

103
Q

What is a single-blinded trial design?

A

Only the investigator is aware of the treatment assignment

104
Q

What is a double-blinded trial design?

A

Investigator(s) and subjects are unaware of treatment assignment

105
Q

When is a “masked evaluator” used?

A

Device trials when it is not possible to mask treatment assignment from the subject and investigator(s)

106
Q

Why is randomization used?

A

To minimize potential for bias

107
Q

What is a parallel trial design?

A

Subjects are randomly assigned to participate in one arm of the study (i.e. treatment or control group)

108
Q

What is a cross-over trial design?

A

Subjects are randomly assigned to participate in one arm of the study and then switched over to the other arm after a specified period.

109
Q

What is a stratified trial design?

A

Subjects are statistically allocated to treatment arms based on characteristics that may affect the outcome of the study

110
Q

What is a matching trial design?

A

Subjects are paired according to characteristics and then one is assigned to treatment and the other to control

111
Q

What is a CRF?

A

Case report form or data collection form
Anything that needs to be entered into the database and analyzed to determine the study’s endpoints and evaluation of safety

112
Q

What is a PI?

A

Principal investigator
Lead investigator at the site who takes full responsibility for conduct of the trial and activities of his/her designated staff

113
Q

What is a sub-investigator?

A

Qualified individuals who assume various for the medical/scientific conduct of the study as designated by the PI

114
Q

What are some PI specific responsibilities?

A

Determining subject eligibility
AE, SAE/SADE, and UADrE/UADE assessment(s) and reporting
Keeping sponsor informed of IRB approvals
CRF sign-off

115
Q

What is documentation?

A

All records that describe or record the methods, conduct, results, and factors affecting a trial, and the actions taken

116
Q

What are source documents?

A

First hard copies on which clinical observations are recorded
Legally valid raw data that support a study’s findings

117
Q

What is a study coordinator?

A

Individual at the study site who is designated by the PI to assume various responsibilities for the daily conduct of the study

118
Q

What are some study coordinator responsibilities?

A 
Subject ID
Screening and enrollment
CRF completion
Maintenance of regulatory (essential) documents
Reporting AEs and deviations
Communicating with the IRB
119
Q

How can an investigator get disqualified?

A

Beginning study without prior FDA/IRB approval
Ignoring dictates of IRB
Falsifying data
Failure to get informed consent and deceiving the patient
Deviating from the protocol or established procedures
Refusal of file audits

120
Q

What is a sponsor?

A

Individual/company/governmental agency/academic institution/private organization who funds a study

121
Q

What are some sponsor responsibilities?

A 
Select qualified investigators
Monitor progress of trial and safety
Ensure protocol compliance
Drug disposition and reconciliation
Maintain required records and reports
Transfer of obligations to a CRO
122
Q

What is study management?

A

Clinical/project manager responsible for the overall development, implementation, and management of the clinical trial to ensure compliance with Sponsor’s responsibilities

123
Q

What is a medical monitor?

A

Medical doctor responsible for assessment of AE and relationship to investigational product and interpretation of clinical study results

124
Q

What is the purpose of monitoring?

A

Verify that rights and well beings of human subjects are protected, data integrity, and trial is conducted in accordance to currently approved protocol, GCP, applicable regulatory requirements and SOPs

Biology (4 decks)

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