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clinical trials Flashcards

1
Q

It 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 Trials

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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 Trials

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3
Q

These are exploratory trial phases

A

Phase 0
Phase II

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4
Q

It is termed as the non-therapeutic phase

A

Phase I

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5
Q

It is known as the therapeutic confirmatory phase

A

Phase III

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6
Q

It is called the post-approval or the post-marketing surveillance phase

A

Phase IV

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7
Q

Study participants are randomly assigned to a group

A

Randomized Trial

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8
Q

A type of CT where both study subjects and the researchers are aware of the drug being tested.

A

Open-label Clinical Trial

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9
Q

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

A

Single-Blind Clinical Trial

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10
Q

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

A

Double-Blind Clinical Trial

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11
Q

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

A

Placebo

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12
Q

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

A

Add-On

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13
Q

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

A

Single-Center

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14
Q

A study is being carried out at multiple places/locations/centers

A

Multi-Center

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15
Q

Clinical trials are broadly classified into:

A

Controlled and Uncontrolled Trials

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16
Q

These 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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17
Q

These 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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18
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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19
Q

Equal and small groups of both cases and controls

A

Block Randomization

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20
Q

Randomization based on the age of the participant and other covariates

A

Stratified Randomization

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21
Q

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

A

Co-Variate Adaptive Randomization/Minimization

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22
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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23
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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24
Q

Patients are allocated to one of the two trial arms

A

Allocation by Randomized Consent (Zelen Trials)

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25
Q

Clinical research design has two major types that include:

A

Non-Interventional / Observational
Interventional / Experimental

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26
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
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27
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

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28
Q

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

A

Crossover

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29
Q

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

A

Factorial

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30
Q

This study evaluates the time/duration of the drug therapy

  • It uses a placebo to understand the efficacy of a drug in treating the disease
A

Randomized Withdrawal Approach

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31
Q

Recruit patients with the same characteristics.

• Less Variability

A

Matched Pairs

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32
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 defined population.

A

Cross-Sectional Study Design

33
Q

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

A

therapeutic or non-therapeutic

34
Q

This type of clinical trial uses a drug that may be beneficial to the patient.

A

therapeutic

35
Q

In this type of clinical trial, the participant does not benefit from the drug. It provide additional knowledge of the drug for future improvements.

A

non-therapeutic

36
Q

The clinical trial process involves:

A

• Protocol Development
• Designing a Case Record/Report Form
• Functioning of Institutional Review Boards

• Data Management
• Monitoring Clinical Trial Site Activities

37
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)

38
Q

The clinical study is conducted by a:

A

sponsor or a clinical research organization (CRO)

39
Q

NOTE: The two most important points to consider before the initiation of the clinical trial include whether there is a need for a clinical trial, if there is a need, then one must make sure that the study design and methodology are strong for
the results to be reliable to the people.

A
40
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

Phase 0

41
Q

• Around less than 50 healthy subjects are recruited.
• Establishes a safe dose range, and the MTD.
• Examines the pharmacokinetic and pharmacodynamic effects.
• Usually single-center studies.

A

Phase I

42
Q

Phase IA

A

Focus: Single Ascending Dose (SAD) and Maximum Tolerated Dose (MTD)
Duration: 1 week to several months
Includes: 6-8 groups of 3-6 participants

43
Q

Phase IIB

A

Focus: Multiple Ascending Doses (MAD) and the dose is gradually narrowed down.
Includes: Three groups of 8 individuals each.

44
Q

• 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.
• Usually, multicentre studies.

A

Phase II

45
Q

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

A

Phase IIA

46
Q

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

A

Phase IIB

47
Q

• More than 300 patients (up to 3000) of
either sex are recruited in this study and
are multicentric trials.
• Pre marketing phase examines the efficacy and the safety of the drug.

A

Phase III

48
Q

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

A

Phase III

49
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

Phase IV

50
Q

Phase I CT

A

• Dose Escalation (SAD)
• Safety Monitoring
• Maximum Tolerated Dose (MTD)

51
Q

Phase II CT

A

• Efficacy Evaluation
• Safety Profile
• Dose Optimization

52
Q

Study Design and Methodology

A

• Protocol Development
• Randomization
• Blinding

53
Q

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

A

Inclusion Criteria

54
Q

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

A

Exclusion Criteria

55
Q

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

A

Recruitment Strategies

56
Q

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

A

Primary Endpoint

57
Q

Biological indicators used to track treatment response and disease progression.

A

Biomarkers

58
Q

Additional measures to support
primary endpoint and gather more data.

A

Secondary Endpoints

59
Q

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

A

Quality of Life

60
Q

Systematic documentation of any
unexpected medical occurrences during
the trial.

A

Adverse Event Reporting

61
Q

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

A

Vital Signs Monitoring

62
Q

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

A

Laboratory Tests

63
Q

Phase III CT

A

• Large Scale Testing
• Comparative Studies
• Long-Term Studies
• Regulatory Submission

64
Q

Phase III Trial Design and Enrollment

A

• Protocol Development
• Patient Recruitment
• Randomization
• Treatment Administration

65
Q

Regulatory Approval Process for Phase III

A

• Pre-NDA Meeting
• NDA Submission
• FDA Review
• Advisory Committee

66
Q

Discussion with regulatory agency about submission requirements

A

Pre-NDA Meeting

67
Q

Comprehensive application including all clinical and non-clinical data.

A

NDA Submission

68
Q

Thorough evaluation of submitted data by expert panels.

A

FDA Review

69
Q

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

A

Advisory Committee

70
Q

It is a systematic process of evaluating the clinical trial operations at the site. It 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

71
Q

• Focuses on safety and feasibility of new drug candidates.
• Preclinical to early clinical trials.
• 30-day FDA review.

A

Investigational New Drug (IND) Application

72
Q

• Comprehensive evaluation of efficacy and safety.
• Late-stage clinical trials and manufacturing data.
• 10-month comprehensive FDA
review.

A

New Drug Application (NDA)

73
Q

List of objectionable conditons/processes prepared by the FDA Investigator and submitted to the auditee at the end or the inspection

A

483

74
Q

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

A

482

75
Q

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

76
Q

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

77
Q

Strategies for Successful
NDA Submission

A

• Effective Communication
• Robust Data
• Meticulous Planning
• Regulatory Compliance

78
Q

Phase IV Clinical Trials

A

• Safety Monitoring
• Efficacy Studies
• Population Impact
• Cost Effectiveness

DDD (9 decks)

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