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Clinical Trials > Clinical Trial Design > Flashcards

Clinical Trial Design Flashcards

1
Q

Important consideration

A
  1. Safety consideration
  2. Avoid all areas of bias
  3. Measurable Endpoints (accepted and approval)
  4. Design that allows statistical analysis

What clinical effect we need to see?
How many individual are enough to accurately see the effect?

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2
Q

Investigational Review Board

A

Group of experts to approve, monitor and review research involving humans

Physicians, nurse, ethicists, community members and others trained to asses clinical trials

Assess

  1. Study protocol & documents
  2. Patient safety monitoring
  3. Procedures to assure patient confidentiality
  4. Informed consent
  5. Ongoing risks and benefits
  6. Recruitment strategy requirement
  7. Proper documentation
  8. Ongoing unannounced progress monitoring
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3
Q

Clinical site preparation

A

Once study received by FDA & institutional IRB approves
Can take 3 to 6 months

  1. Clinical trial unit approval
  2. GLP training
  3. Site Initiation Meeting
  4. Study opens & participants are enrolled
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4
Q

Time period for clinical trial phases

A

Phase I : 6 - 12 months

Phase II: 1 - 2 yrs

Phase III: 2 - 5 yrs

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5
Q

IND (Investigational new drug)
NDA (New drug Application)
Filing times

A

IND : After preclinical & Before phase 0

NDA: After phase III

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6
Q

Requirements for guidelines of CT of new drug comes under

A

Schedule Y

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7
Q

Optimal dose determineed in which phase of clinical trial

A

Phase 2

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8
Q

ADR or new indication

A

Phase 4

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9
Q

Anticancer /HIV drugs can be started in which phase

A

Phase 1

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10
Q

When in phase 1 healthy individual are not taken

A

When drug under trial is anticancer or other harmful drug that can cause serious side effects in healthy patients

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11
Q

No of volunteers required in phases

A

Phase 0: 10 - 20
Phase I : 20 - 80
Phase II : 100 - 300
Phase III :1000 - 3000

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12
Q

Safety and efficacy studies

Pharmacokinetics

A

Phase 1

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13
Q

Comparison of new drug with already marketing standard drug

A

Phase 3

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14
Q

Therapeutic confirmation phase

A

Phase 3

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15
Q

Optimum dose therapy
Therapeutic window
Therapeutic index

A

Phase 2

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16
Q

Randomization & single / double blind studies

A

Phase 3

17
Q

Innovator company takes approval from IRB

A

Before Phase 0

18
Q

Life of a patented drug

A

20 yrs

19
Q

ANDA abbreviated new drug Application for

A

Generic drug ( patent of drug expired now everyone can make it)

20
Q

Randomization methods

A 
Simple randomization (coin flip)
Random permuted blocks  (ABBA | BABA | BBAA | ABAB)
Stratification

Clinical Trials (5 decks)

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