Frameworks Flashcards
(15 cards)
The “original” framework
T1 = pre-clinical (lab/animal) –> application in humans
T2 = application in humans –> established “every day” best practices in community
Updated, newer translational framework in current use
What is T0 in the context of translational research?
Basic and applied science research
Includes preclinical and animal studies, defining mechanisms, targets, and lead molecules.
What activities are included in T1 of translational research?
Proof of concept studies and Phase 1 clinical trials
Focuses on new methods of prevention, diagnosis, and treatment.
What is the focus of T2 in translational research?
Translation to patients
Involves Phase 2 and Phase 3 clinical trials and controlled studies leading to effective care.
What does T3 represent in the translational research framework?
Translation to practice
Encompasses Phase 4 clinical trials, clinical outcomes research, and implementation science research.
What is the goal of T4 in translational research?
Translation to community
Involves population-level outcomes research to demonstrate true benefit to society.
Fill in the blank: T0 involves _______.
Basic and applied science research
True or False: T1 includes population-level outcomes research.
False
T1 focuses on proof of concept studies and Phase 1 clinical trials.
What is the primary outcome of T3 in translational research?
Translation into practice: Delivery of recommended and timely care to the right patient
Phase 4 clnical trials, clinical outcomes research
What type of studies are conducted in T2?
Phase 2 and Phase 3 clinical trials
What is the significance of T4 in translational research?
True benefit to society
What are the key elements that successful translational research must consider?
Business, regulatory, reimbursement, and adoption elements
These elements are necessary to help an innovation achieve scaled commercial success.
Fill in the blank: Successful translational research needs to take into consideration the _______ elements needed to help an innovation become a scaled commercial success.
business, regulatory, reimbursement, and adoption
NCATS Translational Science Spectrum
(from Austin, Clin Transl Sci 2021 reading and Jim’s slides)
Process is nonlinear and dynamic with patient at the center
