Brainscape's Knowledge GenomeTM

Browse over 1 million classes created by top students, professors, publishers, and experts.


See full index

DDD > CLINICAL TRIALS > Flashcards

CLINICAL TRIALS Flashcards

1
Q

It is systematic process that is intended to find out the safety and efficacy of a drug/device in treating/preventing/diagnosing a disease or a medical condition.

A

CLINICAL TRIAL

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
2
Q

A clinical trial is a systematic process that is intended to find out the safety and efficacy of a drug/device in ___/____/___ a disease or a medical condition.

A

TREATING/ PREVENTING/ DIAGNOSING

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
3
Q

It involves the study of the effect of an investigational drug/any other intervention in a defines population/participant.

A

CLINICAL TRIAL

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
4
Q

The new FDA guidelines include five (5) phases:

A

PHASE 0 (micro-dosing studies)
PHASE 1
PHASE 2
PHASE 3
PHASE 4

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
5
Q

Phase 0 and Phase 2 are called?

A

EXPLORATORY TRIAL PHASES

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
6
Q

Phase 1 is termed the?

A

NON-THERAPEUTIC PHASE

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
7
Q

Phase 3 is knows as the?

A

THERAPEUTIC CONFIRMATORY PHASE

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
8
Q

Phase 4 is called the?

A

POST-APPROVAL OR POST-MARKETING SURVEILLANCE PHASE

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
9
Q

Type of Clinical Trial:

A

RAMDOMIZED TRIAL
OPEN LABEL
BLINDED (SINGLE BLIND)
DOUBLE-BLINE (DOUBLE-BLIND)
PLACEBO
ADD-ON
SINGLE CENTER
MULTI-CENTER

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
10
Q

Study participants are randomly assigned to a group.

A

RANDOMIZED TRIAL

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
11
Q

Both study subjects and the researchers are aware of the drug being tested.

A

OPEN-LABEL

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
12
Q

In____ , the subject has no idea about the group (test/control) in which they are placed

A

BLINDED (SINGLE-BLIND)

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
13
Q

In the ____ study, the subjects as well ad the investigator have no idea about the test/control group.

A

DOUBLE-BLIND (DOUBLE-BLIND)

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
14
Q

A substance that appears like a drug but has no active moiety.

A

PLACEBO

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
15
Q

An additional drug apart from the clinical trial drug given to a group of study participants.

A

ADD ON

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
16
Q

A study being carried out a particular place/location/center.

A

SINGLE CENTER

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
17
Q

A study is being carried out at multiple places/location/centers.

A

MULTI-CENTER

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
18
Q

Clinical trials are broadly classified into?

A

CONTROLLED and UNCONTROLLED TRIALS

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
19
Q

Are potentially biased, and the results of such research are not considered as equally as the controlled studies.

A

UNCONTROLLED TRIALS

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
20
Q

Are considered the most effective clinical trials, wherein the bias is minimized, and the results are considered reliable.

A

RANDOMIZED CONTROLLED TRIALS (RCTs)

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
21
Q

The participants are assigned to a case or a control group baser on flipping coin results/computer assignment.

A

SIMPLE RANDOMIZATION

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
22
Q

Equal and small group of both cases and controls.

A

BLOCK RANDOMIZATION

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
23
Q

Randomization based on the age of the participant and other covariates.

A

STRATIFIED RANDOMIZATION

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
24
Q

Sequential assignment of a new participants into a group based on the covariates.

A

CO-VARIATE ADAPTIVE RANDOMIZATION/MINIMIZATION

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
25
Q

One intervention is administered to one-half of the body and the comparator intervention is assigned to another half of the body.

A

RANDOMIZATION BY BODY HALVES Or PAIRED ORGANS (SPLIT BODY TRIALS)

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
26
Q

Intervention is administered to clusters/groups by randomization to prevent contamination and either active or comparator intervention is administered for each group.

A

CLUSTERED RANDOMIZATION

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
27
Q

Patients are allocated to one of the two trial arms.

A

ALLOCATION BY RANDOMIZED CONSENT (ZELEN TRIALS)

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
28
Q

Clinical research design has two major types:

A

NON-INTERVENTIONAL/OBSERVATIONAL
INTERVENTIONAL/EXPERIMENTAL

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
29
Q

It may have a comparator group (analytical studies like case-control and cohort studies), or without it (descriptive study)

A

NON-INTERVENTIONAL STUDIES

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
30
Q

The non-interventional studies may have a _____ (analytical studies like case-control and cohort studies) or without it (descriptive studies)

A

COMPARATOR GROUP

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
31
Q

The experimental studies may be either?

A

RANDOMIZED OR NON-RANDOMIZED

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
32
Q

It may be either randomized or non-randomized?

A

EXPERIMENTAL STUDIES

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
33
Q

It has several types including parallel design, crossover design, factorial design, randomized withdrawal approach, adaptive design, superiority design, and non-inferiority design.

A

CLINICAL TRIAL DESIGNS

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
34
Q

Randomization type:

A

• SIMPLE RANDOMIZATION
• BLOCK RANDOMIZATION
• STRATIFIED RANDOMIZATION
• CO-VARIATE ADAPTIVE RANDOMIZATION/MINIMIZATION
• RANDOMIZATION BY BODY HALVES OR PAIRED ORGANS (SPLIT BODY TRIALS)
• CLUSTERED RANDOMIZATION
• ALLOCATED BY RANDOMIZED CONSENT (ZELEN TRUALS)

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
35
Q

This is the most frequent design wherein each arm of the study group is allocated a particular treatment (placebo(an inert substance)/therapeutic drug)

A

PARALLEL - RANDOMIZED

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
36
Q

The patient in this trial gets each drug and the patients serve as a control themselves.

A

CROSSOVER - RANDOMIZED

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
37
Q

Two or more interventions on the participants and the study can provide information on the interactions between the drugs.

A

FACTORIAL - NON-RANDOMIZED

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
38
Q

This study evaluates the time/duration of the drug therapy.

A

RANDOMIZED WITHDRAWAL APPRACH - RANDOMIZED

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
39
Q

Recruit patients with the same characteristics.

A

MATCHED PAIRS - POST APPROVAL STUDY

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
40
Q

It is the most frequently performed clinical research.

This type of research is undertaken to analyze the presence or absence of a disease/condition, potential risk factors, and prevalence and incidence rates in a defines population.

A

OBSERVATIONAL RESEARCH USING CROSS-SECTIONAL STUDY DESIGN

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
41
Q

Clinical trials may be ___ or ___ depending on the type of intervention.

A

THERAPEUTIC or NON-THERAPEUTIC TYPE

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
42
Q

The _____ of clinical trial uses a drug that mey be beneficial to the patient

A

THERAPEUTIC

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
43
Q

A ____ clinical trial, the participant does not benefit from the drug. It provide additional knowledge of the drug for future improvements.

A

NON-THERAPEUTIC TYPE

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
44
Q

It is the most significant document in a clinical study.

It contains the information collected by the investigator about each subject participating in a clinical study/trial.

A

CASE RECORD/REPORT FORM (CRF)

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
45
Q

A clinical study is conducted by a?

A

SPONSOR or a CLINICAL RESEARCH ORGANIZATION (CRO)

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
46
Q

Examines too low (1/100th) concentrations (micro-dosing) of the drug for less time. Study the pharmacokinetics and determine the dose for phase I studies.

A

SAFETY ASSESSMEMT

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
47
Q

Around <50 healthy subjects are recruiter. Establishes a safe dose range, and the MTD. Examines the pharmacokinetic and pharmacodynamic effects.

A

PHASE I

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
48
Q

Recruiting around 5-100 patients of either sex. Examines the effective dosage and the therapeutic effects on patients. It decides the therapeutic regimen and drug-drug interactions.

A

PHASE II

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
49
Q

More than 300 patients (up to 3000) of either sec are recruited in this study and ate multicentric trials. Premarketing phase examined the efficacy and the safety of the drug. Comparison of the test drug with the placebo/standard drug. Adverse drug reaction/adverse events are noted. Initiate the process of NDA with appropriate regulatory agencies like FDA.

A

PHASE III

50
Q

After approval/post-licensure and post-marketing studies/surveillance studies. Following up on the patients for an exceptionally long time for potential adverse reactions and drug-drug interactions.

A

PHADE IV

51
Q

MTD

A

MAXIMUM TOLERATED DOSE

52
Q

SAD

A

SINGLE ASCENDING DOSE

53
Q

MAD

A

MULTIPLE ASCENDING DOSE

54
Q

NDA

A

NEW DRUG APPLICATION

55
Q

FDA

A

FOOD AND DRUGS ADMINISTRATION

56
Q

Phase I clinical trials:

A

• DOSE ESCALATION
• SAFETY MONITORING
• MAXIMUM TOLERABLE DOSE

57
Q

Phase I trials typically start with a very low dose of the investigational product and gradually increase the dose in a controlled manner.

A

DOSE ESCALATION

58
Q

Participants are closely monitored for any adverse events or side effects, and the dose is adjusted accordingly.

A

SAFETY MONITORING

59
Q

The trial aims to identify the maximum tolerated dose (MTD), which is the highest dose that can be safely administered without causing unacceptable side effects:

A

MAXIMUN TOLERATED DOSE

60
Q

Phase II Clinical Trials:

A

• EFFICACY EVALUATION
• SAFETY PROFILE
• DOSE OPTIMIZATION

61
Q

Determine if the drug shows promising results in treating the target condition.

A

EFFICACY EVALUATION

62
Q

Monitor and assess potential side effects and risks associated with the treatment.

A

SAFETY PROFILE

63
Q

Identify the optimal dosage that balances effectiveness and safety for patients.

A

DOSE OPTIMIZATION

64
Q

Study Design and Methodology:

A

• PROTOCOL DEVELOPMENT
• RANDOMIZATION
• BLINDING

65
Q

Study Design and Methodology:

A

• PROTOCOL DEVELOPMENT
• RANDOMIZATION
• BLINDING

66
Q

Create a detailed plan outlining study procedures, endpoints, and statistical methods.

A

PROTOCOL DEVELOPMENT

67
Q

Assign participants to treatment groups to minimize bias and ensure statistical validity.

A

RANDOMIZATION

68
Q

implement single ir double-blinding to prevent bias in data collection and analysis.

A

BLINDING

69
Q

Patient Population and Recruitment:

A

• INCLUSION CRITERIA
• EXCLUSION CRITERIA
• RECRUITMENT STRATEGIES

70
Q

Specific disease characteristics, age range, and health status for eligibility.

A

INCLUSION CRITERIA

71
Q

Conditions or factors that could interfere with the study or patient safety.

A

EXCLUSION CRITERIA

72
Q

Outreach through healthcare providers, patient advocacy groups, and targeted advertising.

A

RECRUITMENT STRATEGIES

73
Q

Outreach through healthcare providers, patient advocacy groups, and targeted advertising.

A

RECRUITMENT STRATEGIES

74
Q

Efficacy Endpoints and Assessments

A

• PRIMARY ENDPOINT
• SECONDARY ENDPOINT
• BIOMARKERS
• QUALITY OF LIFE

75
Q

Main outcome measure, such as tumor size reduction ot symptom improvement.

A

PRIMARY ENDPOINT

76
Q

Additional measures to support primary endpoint and gather more data.

A

SECONDARY ENDPOINT

77
Q

Biological indicators used to track treatment response and disease progression.

A

BIOMARKERS

78
Q

Patient-reported outcomes to assess overall well-being and treatment impact.

A

QUALITY OF LIFE

79
Q

Safety Monitoring and Data Collection

A

• ADVERSE EVENT REPORTING
• VITAL SIGNS MONITORING
• LABORATORY TESTS

80
Q

Systematic documentation of any unexpected medical occurrence during the trial.

A

ADVERSE EVENT REPORTING

81
Q

Regular checks of blood pressure, heart rate, and other essential health indicators.

A

VITAL SIGNS MONITORING

82
Q

Phase III Clinical Trials:

A

• LARGE-SCALE TESTING
• COMPARATIVE STUDIES
• LONG-TERM EFFECTS
• REGULATORY SUBMISSION

83
Q

Phase III Trial Design and Enrollment

A

• PROTOCOL DEVELOPMENT
• PATIENT RECRUITMENT
• RANDOMIZATION
• TREATMENT ADMINISTRATION

84
Q

Involves hundreds to thousands of patients across multiple centers.

A

LARGE-SCALE TESTING

85
Q

Often compares new treatment to current standard of care ot placebo.

A

COMPARATIVE STUDIES

86
Q

Monitors for side effects and evaluates long-term efficacy.

A

LONG-TERM EFFECTS

87
Q

Data from Phase III trials ate crucial for regulatory approval.

A

REGULATORY SUBMISSION

88
Q

Detailed plan outlining trial objectives, design, and methods.

A

PROTOCOL DEVELOPMENT

89
Q

Rigorous screening process to ensure eligible participants.

A

PATIENT RECRUITMENT

90
Q

Patients randomly assigned to treatment ot control groups.

A

RANDOMIZATION

91
Q

Strict adherence to protocol for dosing and follow-up.

A

TREATMNET ADMINISTRATION

92
Q

Regulatory Approval Process for Phase III:

A

• PRE-NDA MEETING
• NDA SUBMISSION
• FDA REVIEW
• ADVISORY COMMITTEE

93
Q

Discussion with regulatory agency about submission requirements.

A

PRE-NDA MEETING

94
Q

Comprehensive application including all clinical and non-clinical data.

A

NDA SUBMISSION

95
Q

Thorough evaluation of submitted data by expert panels.

A

FDA REVIEW

96
Q

Public meeting to discuss benefits and risks of the new treatment.

A

ADVISORY COMMITTEE

97
Q

Among the most significant aspects of a clinical trial?

A

AUDIT

98
Q

A systematic process of evaluating the clinical trial operations at the site.

A

AUDIT

99
Q

It ensures that the clinical trial process is conducted according yo the protocol, and predefined quality system procedures, following GCP guidelines, and according to the requirements of regulatory authorities.

A

AUDIT

100
Q

The NDA Submission and Review Timeline

A

• NDA SUBMISSION
• FDA REVIEW
• FDA APPROVAL

101
Q

The completed NDA us filed with the FDA review.

A

NDA SUBMISSION

102
Q

The FDA has 10 months to review the NDA and make a decision.

A

FDA REVIEW

103
Q

If approved, the drug can be marketed and sold in the United States.

A

FDA APPROVAL

104
Q

Phase IV Clinical Trials:

A

• SAFETY MONITORING
• EFFICACY STUDIES
• POPULATION IMPACT
• COST-EFFECTIVESS

105
Q

Continuous tracking of adverse events in real-world settings.

A

SAFETY MONITORING

106
Q

Additional research to confirm long-term benefits and risks.

A

EFFICACY STUDIES

107
Q

Assessing treatment effects in diverse patient groups.

A

POPULATION IMPACT

108
Q

Evaluating economic impacts of the nee treatment.

A

COST-EFFECTIVENESS

109
Q

Key differences Between IND and NDA

A

• FOCUS
• TIMING
• PREVIEW PROCESS

110
Q

Safety and feasibility of new drug candidate.

A

IND

111
Q

Comprehensive evaluation of efficacy ad safety.

A

NDA

112
Q

Preclinical to early clinical trials.

A

IND

113
Q

Late-stage clinical trials and manufacturing data.

A

NDA

114
Q

30-day FDA review

A

IND

115
Q

10-month comprehensive FDW review

A

NDA

116
Q

Strategies tor Successful NDA submission:

A

• EFFECTIVE COMMUNICATION
• ROBUST DATA
• METICULOUS PLANNING
• REGULATORY COMPLIANCE

117
Q

Maintain open dialogue with the FRW throughout the NDA process.

A

EFFECTIVE COMMUNICATION

118
Q

Ensure comprehensive and well-organized clinical trial data in the NDA.

A

ROBUST DATW

119
Q

Develop a detailed timeline and strategy for NDW preparation and submission.

A

METICULOUS PLANNING

120
Q

Adhere to strictly to all FRW guidelines and regulations throughout the process.

A

REGULATORY COMPLIANCE

121
Q

identifical in appearance to the treatment drug.

A

PLACEBO

DDD (11 decks)

Brainscape helps you reach your goals faster, through stronger study habits.
© 2024 Bold Learning Solutions. Terms and Conditions