translational research alongside clinical trials Flashcards
what is translational research
translation of basic scientific research to human studies
what are the aims of translational research
produce new:
- tools for diagnosing disease
- medical devices
- prevention methods
- therapeutics
what is the T0 layer
basic science research: preclinical and animal studies
what is the T1 layer
translation to human: phase 1 clinical trial
what is the T2 layer
translation to patients: phase 2/3 trials
what is the T3 layer
translation to practise: phase 4 clinical trials
what is the T4 layer
translation to community: population-level outcomes research
what layers can the valley of death occur
T0-T2
why is clinical trial rate failure high
lack of funding, lack of relevance to human disease
what is a biomarker
a defined characteristic that is measured as an indicator of normal biological processes , pathogenic processes or responses to an exposure or intervention including therapeutic interventions
how can biomarkers be used in clinical trials
prognostic and predictive
what are prognostic biomarkers
predicts how a disease may develop in an individual regardless of type of treatment
what are predictive biomakers
provides an indication of the probable effect of treatment on the patient
what is the clinical utility design 1
Looks at the clinical risk and the biomarkerrisk that a patient is assigned. If those risks agree then they’re at high risk. If the risks don’t agree then it is a low risk category
what is clinical utility 2
When patients are categorised into different risk categories based on their biomarker .Intermediate risk : are randomised to high risk
or low risk group
what is the randomise-all design
patients are randomised to standard of care arm or to the experimental arm and then the patients are stratified into their biomarker groups, you can make several comparisons
what is the interaction (biomarker-stratified design)
first stratified for the biomarker and then they’re randomised to standard of experimental designs.
what is the biomarker-strategy design
test the merits of biomarker strategy, patients are randomised to a non - biomarker strategy are offerred standard of care and then the biomarker strategy are offerred the experimental
what is targeted or selection design
where biomarker - ve are taken off the biomarker + ve are then randomised to standard of care group or
experim ental
what is adoptive parallel design
developed to improve efficiency of clinical trials In seed of waiting many years to see if the trial was successful. Allows you to adapt trials whilst they take place
