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DDD > Clinical Studies > Flashcards

Clinical Studies Flashcards

1
Q

A ___ is a 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

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2
Q

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

A

Clinical Trial

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3
Q

The new FDA guidelines includes five (5) phases of clinical trials:

A

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

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4
Q

Phase 0 and phase 2

A

Exploratory Trial Phases

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5
Q

Phase 1

A

Non-Therapeutic Phase

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6
Q

Phase 3

A

Therapeutic Confirmatory Phase

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7
Q

Phase 4

A

Post-Approval or Post-Marketing Surveillance Phase

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8
Q

Study participants are randomly assigned to a group.

A

Randomized trial

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9
Q

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

A

Open-label

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10
Q

In this study, the subject has no idea about the group (test/control) in which they are placed.

A

Blinded (single-blind)

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11
Q

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

A

Double-blind

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12
Q

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

A

Placebo

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13
Q

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

A

Add-on

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14
Q

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

A

Single center

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15
Q

A study is being carried out at multiple places/location/carriers

A

Multi-center

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16
Q

Clinical trials are broadly classified into ___ and ___ .

A

controlled and uncontrolled trials

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17
Q

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

A

Uncontrolled trials

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18
Q

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

A

Randomized controlled trials (RCTs)

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19
Q

Randomizations in Clinical Trials (7)

A
  • Simple randomization
  • Block randomization
  • Stratified randomization
  • Co-variate adaptive randomization/minimization
  • Randomized by body halves or paired organs (Split body trials)
  • Clustered randomization
  • Allocation by randomized consent (Zelen trials)
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20
Q

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

A

Simple randomization

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21
Q

Equal and small groups of both cases and controls

A

Block randomization

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22
Q

Randomization based on the age of the participant and other covariates

A

Stratified randomization

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23
Q

Sequential assignment of a new participant into a group based on the covariates

A

Co-variate adaptive randomization/minimization

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24
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)

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25
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

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26
Q

Patient are allocated to one of the two trial arms

A

Allocation by randomized consent (Zelen trials)

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27
Q

Clinical research design has two major types that include ___ and
___ .

A

non-interventional/observational and interventional/experimental studies

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28
Q

The non-interventional studies may have a comparator group (analytical studies like case-control and cohort studies), or without it (descriptive study). The experimental studies may be either randomized or non-randomized.

A

non-interventional studies

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29
Q

Clinical trial designs are of several types including (7)

A
  • parallel design,
  • crossover design,
  • factorial design,
  • randomized withdrawal approach,
  • adaptive design,
  • superiority design, and
  • non-inferiority design
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30
Q

Types of Trial Designs (5)

A

Randomized Study:
- Parallel
- Crossover
- Randomized withdrawal approach

Non-randomized Study:
- Factorial

Post-Approval Study:
- Matched pairs

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31
Q

NATURE OF TRIAL STUDY

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

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32
Q

NATURE OF TRIAL STUDY

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

A

Crossover

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33
Q

NATURE OF TRIAL STUDY

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

A

Factorial

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34
Q

NATURE OF TRIAL STUDY

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

A

Randomized withdrawal approach

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35
Q

NATURE OF TRIAL STUDY

Recruit patients with the same characteristics.

A

Matched pairs

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36
Q

DIS/ADVANTAGES OF TRIAL DESIGNS

The placebo arm does not receive the trial drug, so may not get the benefit of it.

A

Parallel

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37
Q

DIS/ADVANTAGES OF TRIAL DESIGNS

Avoids participant bias in treatment and requires a small sample size. This design is not suitable for research on acute diseases.

A

Crossover

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38
Q

DIS/ADVANTAGES OF TRIAL DESIGNS

The study is complex.

A

Factorial

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39
Q

DIS/ADVANTAGES OF TRIAL DESIGNS

The study uses a placebo to understand the efficacy of a drug in treating the disease.

A

Randomized withdrawal approach

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40
Q

DIS/ADVANTAGES OF TRIAL DESIGNS

Less variability.

A

Matched pairs

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41
Q

PRINCIPLES OF CLINICAL TRIALS

___ 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 defined population.

A

Observational research using a cross-sectional study design

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42
Q

PRINCIPLES OF CLINICAL TRIALS

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

A

therapeutic or non-therapeutic

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43
Q

The ___ of clinical trial uses a drug that may be beneficial to the patient. Whereas in a ___ , the participant does not benefit from the drug.

A

therapeutic type;
non-therapeutic clinical trial

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44
Q

The ___ provide additional knowledge of the drug for future improvements.

A

non-therapeutic trials

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45
Q

PREPARING A CLINICAL TRIAL

The clinical trial process involves ___ , ___ , and ___ . It also includes data management and the monitoring of clinical trial site activities.

A

protocol development;
designing a case record/report form (CRF);
functioning of institutional review boards (IRBs)

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46
Q

PREPARING A CLINICAL TRIAL

The ___ 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)

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47
Q

PREPARING A CLINICAL TRIAL

The clinical study is conducted by a ___ or ___ .

A

Sponsor or a Clinical Research Organization (CRO)

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48
Q

PREPARING A CLINICAL TRIAL

A ___ , ___ , and ___ assume significance while planning a clinical trial. What, when, how, and who are planned ___ the initiation of a study trial.

A

perfect protocol;
time limits;
regulatory requirements;
before

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49
Q

PREPARING A CLINICAL TRIAL

The two most important points to consider before the initiation of the clinical trial include ___ , if there is a need, then ___ .

A
  • whether there is a need for a clinical trial;
  • one must make sure that the study design and methodology are strong for the results to be reliable to the people
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50
Q

CLINICAL TRIAL PHASES

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

Phase 0 (Safety Assessment)

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51
Q

CLINICAL TRIAL PHASES

Phase 0 (Safety Assessments) studies the ___ and determine the ___ for phase I studies.

A

pharmacokinetics; dose

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52
Q

CLINICAL TRIAL PHASES

Around <50 healthy subjects are recruited.

A

Phase 1

53
Q

CLINICAL TRIAL PHASES

Establishes a ___ ,
and the ___ . Examines the
___ and ___ .

A

safe dose range and maximum tolerated dose;
pharmacokinetic and pharmacodynamic effects

54
Q

CLINICAL TRIAL PHASES

Phase 1 are usually ___ studies.

A

single-center

55
Q

CLINICAL TRIAL PHASES

Phase 1a

A

Single ascending dose (SAD) and Maximum tolerated dose (MTD)

56
Q

CLINICAL TRIAL PHASES

Phase 1a

Duration of ___ to ___ depending on the trial and includes ___ groups of ___ participants.

A

one week to several months;
6-8 groups of 3-6 participants

57
Q

CLINICAL TRIAL PHASES

Phase 1b ___ and the dose is gradually ___.

A

Multiple ascending doses (MAD);
narrowed down

58
Q

CLINICAL TRIAL PHASES

Phase 1b consists of ___ groups with ___ individuals each.

A

3 groups of 8 individuals each.

59
Q

CLINICAL TRIAL PHASES

Recruiting around 5-100 patients of either sex.

A

Phase 2

60
Q

CLINICAL TRIAL PHASES

Examines the ___ and the
___ on patients. It decides
the therapeutic regimen and drug-drug interactions.

A

effective dosage and the therapeutic effects

61
Q

CLINICAL TRIAL PHASES

Phase 2 are usually ___ studies.

A

Multicenter

62
Q

CLINICAL TRIAL PHASES

Decides the drug dosage, includes 20-30 patients, and takes up to weeks/months.

A

Phase 2a

63
Q

CLINICAL TRIAL PHASES

Studies dose response relationship, drug-drug interactions, and comparison with a placebo.

A

Phase 2b

64
Q

CLINICAL TRIAL PHASES

More than 300 patients (up to 3000) of either sex are recruited in this study and are multicentric trials.

A

Phase 3

65
Q

CLINICAL TRIAL PHASES

___ examines the efficacy and the safety of the drug. Comparison of the test drug with the placebo/standard drug.

A

Premarketing phase

66
Q

CLINICAL TRIAL PHASES

Adverse drug reactions/adverse
events are noted. Initiate the process of NDA with appropriate regulatory agencies like the FDA.

A

Phase 3

67
Q

CLINICAL TRIAL PHASES

Adverse drug reactions/adverse
events are noted. Initiate the process of NDA with appropriate regulatory agencies like the FDA.

A

Phase 4

68
Q

CLINICAL TRIAL PHASES

MTD
SAD
MAD

A

Maximum Tolerated Dose;
Single Ascending Doses;
Multiple Ascending Doses

69
Q

PHASE 1 CLINICAL TRIALS

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

70
Q

PHASE 1 CLINICAL TRIALS

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

A

Safety Monitoring

71
Q

PHASE 1 CLINICAL TRIALS

The trial aims to identify the ___ , which is the highest dose that can be safely administered without causing unacceptable side effects

A

Maximum Tolerated Dose (MTD)

72
Q

PHASE 2 CLINICAL TRIALS

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

A

Efficacy Evaluation

73
Q

PHASE 2 CLINICAL TRIALS

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

A

Safety Profile

74
Q

PHASE 2 CLINICAL TRIALS

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

A

Dose Optimization

75
Q

STUDY DESIGN AND METHODOLOGY

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

A

Protocol Development

76
Q

STUDY DESIGN AND METHODOLOGY

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

A

Randomization

77
Q

STUDY DESIGN AND METHODOLOGY

Implement single or double blinding to prevent bias in data collection and analysis.

A

Blinding

78
Q

PATIENT POPULATION AND RECRUITMENT

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

A

Inclusion Criteria

79
Q

PATIENT POPULATION AND RECRUITMENT

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

A

Exclusion Criteria

80
Q

PATIENT POPULATION AND RECRUITMENT

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

A

Recruitment Strategies

81
Q

EFFICACY ENDPOINTS AND ASSESSMENTS

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

A

Primary Endpoint

82
Q

EFFICACY ENDPOINTS AND ASSESSMENTS

Additional measures to support primary endpoint and gather more data.

A

Secondary Endpoints

83
Q

EFFICACY ENDPOINTS AND ASSESSMENTS

Biological indicators used to
track treatment response and
disease progression.

A

Biomarkers

84
Q

EFFICACY ENDPOINTS AND ASSESSMENTS

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

A

Quality of Life

85
Q

SAFETY MONITORING AND DATA COLLECTION

Systematic documentation of any
unexpected medical occurrences during the trial.

A

Adverse Event Reporting

86
Q

SAFETY MONITORING AND DATA COLLECTION

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

A

Vital Signs Monitoring

87
Q

SAFETY MONITORING AND DATA COLLECTION

Periodic blood work and other diagnostic tests to assess organ function.

A

Laboratory Tests

88
Q

PHASE 3 CLINICAL TRIALS

Involves hundreds to thousands of patients across multiple centers.

A

Large-Scale Testing

89
Q

PHASE 3 CLINICAL TRIALS

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

A

Comparative Studies

90
Q

PHASE 3 CLINICAL TRIALS

Monitors for side effects and evaluates long-term efficacy.

A

Long-Term Effects

91
Q

PHASE 3 CLINICAL TRIALS

Monitors for side effects and
evaluates long-term efficacy.

A

Regulatory Submission

92
Q

Phase 3 Trial Design and Enrollment (4)

A
  • Protocol Development
  • Patient Recruitment
  • Randomization
  • Treatment Administration
93
Q

PHASE 3 TRIAL DESIGN AND ENROLLMENT

Detailed plan outlining trial objectives, design, and methods

A

Protocol Development

94
Q

PHASE 3 TRIAL DESIGN AND ENROLLMENT

Rigorous screening process to ensure eligible participants.

A

Patient Recruitment

95
Q

PHASE 3 TRIAL DESIGN AND ENROLLMENT

Patients randomly assigned to treatment or control groups.

A

Randomization

96
Q

PHASE 3 TRIAL DESIGN AND ENROLLMENT

Strict adherence to protocol for dosing and follow-up.

A

Treatment Administration

97
Q

Regulatory Approval Process for Phase 3: (4)

A
  • Pre-NDA Meeting
  • NDA Submission
  • FDA Review
  • Advisory Committee
98
Q

REGULATORY APPROVAL PROCESS FOR PHASE 3

Discussion with regulatory agency about submission requirements

A

Pre-NDA Meeting

99
Q

REGULATORY APPROVAL PROCESS FOR PHASE 3

Comprehensive application including all clinical and non-clinical data.

A

NDA Submission

100
Q

REGULATORY APPROVAL PROCESS FOR PHASE 3

Thorough evaluation of submitted data by expert panels.

A

FDA Review

101
Q

REGULATORY APPROVAL PROCESS FOR PHASE 3

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

A

Advisory Committee

102
Q

All clinical trials conducted worldwide are posted in this website:

A

https://clinicaltrials.gov/

103
Q

Among the most significant aspects of a clinical trial is the ___ . An ** is a systematic process of evaluating the clinical trial operations at the site. The ** ensures that the clinical trial process is conducted according to the protocol, and predefined quality system procedures, following GCP guidelines, and according to the requirements of
regulatory authorities.

A

Audit

104
Q

The ___ are supposed to be independent and work without the involvement of the sponsors, CROs, or personnel at the trial site. The summary report of the observations of the inspectors is performed using various forms.

A

Auditors

105
Q

FDA Audit Inspection Forms (Number) [4]

A
  • 483
  • 482
  • 1571
  • 1572
106
Q

FDA AUDIT INSPECTION FORMS

List of objectionable conditions/processes prepared by the FDA investigator and submitted to the auditee at the end of the inspection

A

483

107
Q

FDA AUDIT INSPECTION FORMS

The auditors submit their identity proofs and notice of inspections to the clinical investigators and later document their observations

A

482

108
Q

FDA AUDIT INSPECTION FORMS

This document details the fact that the clinical trial is not initiated before 30 days of submitting the IND to the FDA for approval. The form confirms that the IRB complies with 21 CFR Part 56. The form details the agreement to follow regulatory requirements and names all the individuals who monitor the conduct and progress of the study and evaluate the safety of the clinical trial.

A

1571

109
Q

FDA AUDIT INSPECTION FORMS

This form details the fact that the study is conducted after ethics approval ensures that the study is carried out according to protocol, informed consent, and IRB approval.

A

1572

110
Q

The NDA Submission and Review Timeline: (3)

A
  • NDA Submission
  • FDA Review
  • FDA Approval
111
Q

THE NDA SUBMISSION AND REVIEW TIMELINE

The completed NDA is filed with the FDA for review.

A

NDA Submission

112
Q

THE NDA SUBMISSION AND REVIEW TIMELINE

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

A

FDA Review

113
Q

THE NDA SUBMISSION AND REVIEW TIMELINE

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

A

FDA Approval

114
Q

PHASE 4 CLINICAL TRIALS

Continuous tracking of adverse events in real-world settings.

A

Safety Monitoring

115
Q

PHASE 4 CLINICAL TRIALS

Additional research to confirm
long-term benefits and risks

A

Efficacy Studies

116
Q

PHASE 4 CLINICAL TRIALS

Assessing treatment effects in
diverse patient groups.

A

Population Impact

117
Q

PHASE 4 CLINICAL TRIALS

Evaluating economic impacts of the new treatment.

A

Cost-Effectiveness

118
Q

KEY DIFFERENCES BETWEEN IND AND NDA

Focus

Safety and feasibility of new drug
candidates.

A

IND

119
Q

KEY DIFFERENCES BETWEEN IND AND NDA

Focus

Comprehensive evaluation of
efficacy and safety.

A

NDA

120
Q

KEY DIFFERENCES BETWEEN IND AND NDA

Timing

Preclinical to early clinical trials.

A

IND

121
Q

KEY DIFFERENCES BETWEEN IND AND NDA

Timing

Late-stage clinical trials and
manufacturing data.

A

NDA

122
Q

KEY DIFFERENCES BETWEEN IND AND NDA

Review Process

30-day FDA review.

A

IND

123
Q

KEY DIFFERENCES BETWEEN IND AND NDA

Review Process

10-month comprehensive FDA
review.

A

NDA

123
Q

STRATEGIES FOR SUCCESSFUL NDA SUBMISSION

Maintain open dialogue with the FDA throughout the NDA process.

A

Effective Communication

124
Q

STRATEGIES FOR SUCCESSFUL NDA SUBMISSION

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

A

Robust Data

125
Q

STRATEGIES FOR SUCCESSFUL NDA SUBMISSION

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

A

Meticulous Planning

126
Q

STRATEGIES FOR SUCCESSFUL NDA SUBMISSION

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

A

Regulatory Compliance

127
Q

“I get to be a part of the advancement of science and healthcare. I love getting to learn something new every day!”

A

Madison Smith (Clinical Research Coordinator Artemis Institute for Clinical Research)

DDD (4 decks)

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