FIPP 1 EXAM QUESTIONS
WITH CORRECT DETAILED
ANSWERS
What are the barriers patient enrollment in general and to minority involvement in
particular in biomedical research? - Answer-Minorities
Sponsor Barriers: Protocol issues, Adequate Funding, Site Selection, Investigator
Selection
Physician Barriers: Time Constraints, Lack of support staff, Impact on doctor-patient
relationship, Concern for patients, Clinician bias, Poor financial reimbursement, Lack of
interest in the specific research question
Patient barriers: Demands of the study, Preference for a particular treatment, Concerns
about side effects, Comfort level with physician, Language and literacy, Loss of privacy,
Portrayal as guinea pig
List the stages of drug development. - Answer-Pre-IND
IND
Phase 1 clinical trials
Phase 2 clinical trials
Phase 3 clinical trials
NDA
Post-marketing
What is done during the pre-IND phase? - Answer-Define chemical properties of the
drug
Conduct nonclinical pharmacology/toxicology studies
Develop clinical protocol(s)
What is an IND? What types of IND are there? - Answer-A Request to Start Clinical
Trials
Types:
, Commercial IND
Investigator IND (Research IND)
Single-Patient IND
Treatment IND
Emergency IND (EIND)
What does a phase 1 clinical trial do (oncology vs non oncology)? How many patients
does it typically enroll? - Answer-Safety and pharmacokinetics
Generally 20 to ~80 subjects
Closely controlled
Non-oncology: What are the side effects? Is it safe enough to test?
Oncology: What is the dose? Maximum Tolerated? Pharmacodynamic changes? What
are the side effects?
What does a phase 2 clinical trial do (oncology vs non oncology)?How many patients
does it typically enroll? - Answer-Efficacy and safety
Closely monitored
No more than several hundred subjects or patients
Non-oncology: Define doses for Phase 3
What does a phase 3 clinical trial do (oncology vs non oncology)? How many patients
does it typically enroll? - Answer-Efficacy and safety (Evaluate risk vs. benefit)
Several hundred to several thousand subjects
What does a phase 4 clinical trial do? - Answer-No fixed duration / patient population
Starts immediately after marketing
Report all ADRs:
Helps to detect rare ADRs
Drug interactions
Also new uses for drugs [Sometimes called Phase V]
What did the Tegenero (TGN142) study do? - Answer-Phase 1 went wrong
an immune-modulator that could expand T-cell population in the absence of T-cell
receptor activation
Ph 1 study in "healthy normal"
WITH CORRECT DETAILED
ANSWERS
What are the barriers patient enrollment in general and to minority involvement in
particular in biomedical research? - Answer-Minorities
Sponsor Barriers: Protocol issues, Adequate Funding, Site Selection, Investigator
Selection
Physician Barriers: Time Constraints, Lack of support staff, Impact on doctor-patient
relationship, Concern for patients, Clinician bias, Poor financial reimbursement, Lack of
interest in the specific research question
Patient barriers: Demands of the study, Preference for a particular treatment, Concerns
about side effects, Comfort level with physician, Language and literacy, Loss of privacy,
Portrayal as guinea pig
List the stages of drug development. - Answer-Pre-IND
IND
Phase 1 clinical trials
Phase 2 clinical trials
Phase 3 clinical trials
NDA
Post-marketing
What is done during the pre-IND phase? - Answer-Define chemical properties of the
drug
Conduct nonclinical pharmacology/toxicology studies
Develop clinical protocol(s)
What is an IND? What types of IND are there? - Answer-A Request to Start Clinical
Trials
Types:
, Commercial IND
Investigator IND (Research IND)
Single-Patient IND
Treatment IND
Emergency IND (EIND)
What does a phase 1 clinical trial do (oncology vs non oncology)? How many patients
does it typically enroll? - Answer-Safety and pharmacokinetics
Generally 20 to ~80 subjects
Closely controlled
Non-oncology: What are the side effects? Is it safe enough to test?
Oncology: What is the dose? Maximum Tolerated? Pharmacodynamic changes? What
are the side effects?
What does a phase 2 clinical trial do (oncology vs non oncology)?How many patients
does it typically enroll? - Answer-Efficacy and safety
Closely monitored
No more than several hundred subjects or patients
Non-oncology: Define doses for Phase 3
What does a phase 3 clinical trial do (oncology vs non oncology)? How many patients
does it typically enroll? - Answer-Efficacy and safety (Evaluate risk vs. benefit)
Several hundred to several thousand subjects
What does a phase 4 clinical trial do? - Answer-No fixed duration / patient population
Starts immediately after marketing
Report all ADRs:
Helps to detect rare ADRs
Drug interactions
Also new uses for drugs [Sometimes called Phase V]
What did the Tegenero (TGN142) study do? - Answer-Phase 1 went wrong
an immune-modulator that could expand T-cell population in the absence of T-cell
receptor activation
Ph 1 study in "healthy normal"
