GMS6551 MODULE 2 (PART 1) EXAM QUESTIONS AND
ANSWERS WITH COMPLETE SOLUTIONS VERIFIED GRADED A++
What is translational research?
Moving knowledge from basic sciences to clinical settings
What are the phrases used to summarize translational research?
Bench-to-bedside and bedside-to-community research
Who initiated the concept of translational research?
Elias Zerhouni and Francis Collins
What is T0 phase of translational research?
Basic science research, pre-clinical and animal studies
What is T1 phase of translational research?
Translation to humans, new methods of diagnosis, treatment and prevention
What is T2 phase of translational research?
Translation to patients, efficacy of interventions
What is T3 phase of translational research?
Translation to practice, how interventions work in real world
What is T4 phase of translational research?
Translation to community, results in improved global health
What is triple-negative breast cancer?
Translational research applied to TBC
What are the team science flavors?
, Undisciplinary, multidisciplinary, interdisciplinary, transdisciplinary
How does FDA define unmet medical need?
Condition whose treatment or diagnosis is not addressed adequately by available
therapy
What are the immediate and longer-term needs for society in unmet medical
need?
Immediate need for a defined population, longer-term need to address development of
resistance to antibacterial drugs
What are the characteristics of a new drug that treats an unmet medical need?
Treats a condition for which no other treatment exists, confers some benefit that existing
treatments do not, has one or improved effect on a treatment outcome, decreased
toxicity, fewer interactions with other drugs, targets an underserved population, more
cost-effective
Does an unmet medical need have to be a treatment for a disease?
No
What is the unmet health need in breast cancer?
Breast cancer
What is Triple-Negative Breast Cancer and what is its incidence?
10-20% of invasive breast cancers lack estrogen, progesterone, and HER2 receptors.
What is the basic science surrounding Triple-Negative Breast Cancer?
Absence of hormone receptors and HER2.
What are the gaps in our knowledge regarding Triple-Negative Breast Cancer?
Mechanism driving cancer, lack of guidelines, positive biomarker.
ANSWERS WITH COMPLETE SOLUTIONS VERIFIED GRADED A++
What is translational research?
Moving knowledge from basic sciences to clinical settings
What are the phrases used to summarize translational research?
Bench-to-bedside and bedside-to-community research
Who initiated the concept of translational research?
Elias Zerhouni and Francis Collins
What is T0 phase of translational research?
Basic science research, pre-clinical and animal studies
What is T1 phase of translational research?
Translation to humans, new methods of diagnosis, treatment and prevention
What is T2 phase of translational research?
Translation to patients, efficacy of interventions
What is T3 phase of translational research?
Translation to practice, how interventions work in real world
What is T4 phase of translational research?
Translation to community, results in improved global health
What is triple-negative breast cancer?
Translational research applied to TBC
What are the team science flavors?
, Undisciplinary, multidisciplinary, interdisciplinary, transdisciplinary
How does FDA define unmet medical need?
Condition whose treatment or diagnosis is not addressed adequately by available
therapy
What are the immediate and longer-term needs for society in unmet medical
need?
Immediate need for a defined population, longer-term need to address development of
resistance to antibacterial drugs
What are the characteristics of a new drug that treats an unmet medical need?
Treats a condition for which no other treatment exists, confers some benefit that existing
treatments do not, has one or improved effect on a treatment outcome, decreased
toxicity, fewer interactions with other drugs, targets an underserved population, more
cost-effective
Does an unmet medical need have to be a treatment for a disease?
No
What is the unmet health need in breast cancer?
Breast cancer
What is Triple-Negative Breast Cancer and what is its incidence?
10-20% of invasive breast cancers lack estrogen, progesterone, and HER2 receptors.
What is the basic science surrounding Triple-Negative Breast Cancer?
Absence of hormone receptors and HER2.
What are the gaps in our knowledge regarding Triple-Negative Breast Cancer?
Mechanism driving cancer, lack of guidelines, positive biomarker.
