Challenges in Translational Neuroscience From Lab Discoveries to Clinic - Oertel Flashcards
What does translation mean?
‘Translation’ refers to the application of the results of basic biomedical research to the practice of medicine.
It is the process of converting discoveries made in the laboratory into clinical interventions that provide a direct benefit to human health.
Translations can actually occur from bench to bedside and bedside to bench, often with many journeys in both directions.
What is the aim of translational research?
To produce new therapeutics, medical devices, tolls/parameters for diagnosing and monitoring disease, and creating avenues for community engagement research.
What is the “valley of death”?
Translation from basic science to human studies form the critical path, as defined by the FDA, or the “valley of death”, as defined by the pharmaceutical industry. This “valley of death” encompasses T0-T2 phases of research.
What are the phases of traditional research design?
T0 - Basic science research
T1 - Translation to human
T2 - Translation to patients
T3 - Translation to practice
T4 - Translation to community
T0 - Basic science research
Preclinical and animal studies, defining pathology, mechanisms targets and lead molecules and initial regulatory interaction
T1 - Translation to human
Phase 1 clinical trials, safety, proof of mechanism, and proof of concept, PK/PD, new methods of diagnosis, treatment, and prevention.
T2 - Translation to patients
Phase 2/3 clinical trials, dose selection, proof of efficacy, safety. Controlled studies leading to effective care, benefit/risk profile, health economic data.
T3 - Translation to practice
Phase 4 clinical trials and clinical outcomes research, delivery of recommended and timely care to the right patient, post marketing safety, new indications.
T4 - Translation to community
Population level outcomes research, true benefit to society.
