Clinical Trial Design Flashcards
Important consideration
- Safety consideration
- Avoid all areas of bias
- Measurable Endpoints (accepted and approval)
- Design that allows statistical analysis
What clinical effect we need to see?
How many individual are enough to accurately see the effect?
Investigational Review Board
Group of experts to approve, monitor and review research involving humans
Physicians, nurse, ethicists, community members and others trained to asses clinical trials
Assess
- Study protocol & documents
- Patient safety monitoring
- Procedures to assure patient confidentiality
- Informed consent
- Ongoing risks and benefits
- Recruitment strategy requirement
- Proper documentation
- Ongoing unannounced progress monitoring
Clinical site preparation
Once study received by FDA & institutional IRB approves
Can take 3 to 6 months
- Clinical trial unit approval
- GLP training
- Site Initiation Meeting
- Study opens & participants are enrolled
Time period for clinical trial phases
Phase I : 6 - 12 months
Phase II: 1 - 2 yrs
Phase III: 2 - 5 yrs
IND (Investigational new drug)
NDA (New drug Application)
Filing times
IND : After preclinical & Before phase 0
NDA: After phase III
Requirements for guidelines of CT of new drug comes under
Schedule Y
Optimal dose determineed in which phase of clinical trial
Phase 2
ADR or new indication
Phase 4
Anticancer /HIV drugs can be started in which phase
Phase 1
When in phase 1 healthy individual are not taken
When drug under trial is anticancer or other harmful drug that can cause serious side effects in healthy patients
No of volunteers required in phases
Phase 0: 10 - 20
Phase I : 20 - 80
Phase II : 100 - 300
Phase III :1000 - 3000
Safety and efficacy studies
Pharmacokinetics
Phase 1
Comparison of new drug with already marketing standard drug
Phase 3
Therapeutic confirmation phase
Phase 3
Optimum dose therapy
Therapeutic window
Therapeutic index
Phase 2
Randomization & single / double blind studies
Phase 3
Innovator company takes approval from IRB
Before Phase 0
Life of a patented drug
20 yrs
ANDA abbreviated new drug Application for
Generic drug ( patent of drug expired now everyone can make it)
Randomization methods
Simple randomization (coin flip) Random permuted blocks (ABBA | BABA | BBAA | ABAB) Stratification
