2. Evidence generation is multidimensional,
including data sourse, study design and
degree of pragmatism .
Real- world evidence is defined by data
source and degree of pragmatism
independent of study design.
3. Randomized controlled trials have been the
gold standard for evidence generation across
all areas of medicine,as they allow unbiased
estimates of treatment effect without
confounders.
Ideally,every medical treatment or
intervention should be tested via a well –
powered and well controlled .
4. NEED TO BE-
Focused on the key needs of stakeholders
Aligned with the key value drivers of
stakeholders
Aligned with key commercial drivers
Optimally communicated to the stakeholders
5. Internal stakeholder input and validation
Define parameters that demonstrate product
value
Disease area, treatment landscape and col
analysis
Competitor analysis
External stakeholder needs analysis
Evidence-based prioritization of clinical and
value needs/gaps
Analysis of evidence generation modalities to
fill needs /gaps
6. Establish rationale and clinical value of the
study/data
Engage stakeholders and generate
anticipation for the results
Extend the reach of the data
7. ENHENCE ENGEMENT AND REDUCE THE
BURDEN TO DRIVEN ENROLLMENT AND
RETENTION-
Ensure physicians understand the scientific
value of the plan
Provide sites with tools to engage and
explain the value to patients,as requied
Ensure MSLs understand the scientific value
of the plan
Adopt a patient –centric approach throughout
the process
8. Trials in progress /methology publications
Rapid publication of study design/baseline
data at LPI
Interim analyses abstracts
Simultaneous publication of final results
Lay summaries
Sub –population analyses and output
9. W. F. Sharpe (1964)
Rajvir bhalwar
C Chipeta · 2012 ·
10. In conclusion, better evidence can lead to
health improvement in the same way as
direct delivery of healthcare .
Quantitative appraisals of evidence
generation activities are important and
should reflect the impact of improved
evidence on population health.
