translational research alongside clinical trials

Question 1

what is translational research

Answer 1

translation of basic scientific research to human studies

Question 2

what are the aims of translational research

Answer 2

produce new:

• tools for diagnosing disease
• medical devices
• prevention methods
• therapeutics

Question 3

what is the T0 layer

Answer 3

basic science research: preclinical and animal studies

Question 4

what is the T1 layer

Answer 4

translation to human: phase 1 clinical trial

Question 5

what is the T2 layer

Answer 5

translation to patients: phase 2/3 trials

Question 6

what is the T3 layer

Answer 6

translation to practise: phase 4 clinical trials

Question 7

what is the T4 layer

Answer 7

translation to community: population-level outcomes research

Question 8

what layers can the valley of death occur

Answer 8

T0-T2

Question 9

why is clinical trial rate failure high

Answer 9

lack of funding, lack of relevance to human disease

Question 10

what is a biomarker

Answer 10

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

Question 11

how can biomarkers be used in clinical trials

Answer 11

prognostic and predictive

Question 12

what are prognostic biomarkers

Answer 12

predicts how a disease may develop in an individual regardless of type of treatment

Question 13

what are predictive biomakers

Answer 13

provides an indication of the probable effect of treatment on the patient

Question 14

what is the clinical utility design 1

Answer 14

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

Question 15

what is clinical utility 2

Answer 15

When patients are categorised into different risk categories based on their biomarker .Intermediate risk : are randomised to high risk
or low risk group

Question 16

what is the randomise-all design

Answer 16

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

Question 17

what is the interaction (biomarker-stratified design)

Answer 17

first stratified for the biomarker and then they’re randomised to standard of experimental designs.

Question 18

what is the biomarker-strategy design

Answer 18

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

Question 19

what is targeted or selection design

Answer 19

where biomarker - ve are taken off the biomarker + ve are then randomised to standard of care group or
experim ental

Question 20

what is adoptive parallel design

Answer 20

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