1. Using clinical trial data as real-world evidence
Use Cases at the intersection of Real-World Evidence/ OHDSI and Clinical Trials #
Type
Name
Description
Data 1
Using clinical trial data as real-world evidence
To the degree the study data allows, use clinical trial data as another RWE data source, or epidemiological ‘lens’ into a problem for which RWD has been used to solve previously
Answer health outcomes questions
Our 1 2
Using insights from RWE data to help clinical trial design or evaluation
If RWE includes genomics, using RWE to identify biomarkers to create biomarker-homogenous cohorts to use in ‘patient enrichment’ (especially seen in oncology) phases or types of trials, to understand how to define indications/contra-indications that drive up effectiveness, sometimes referred to as precision medicine
Helps design a better trial
Our #13 and 6 3
Utilizing RWE data to mimic clinical trial inclusion/exclusion criteria to enhance recruitment by understanding characteristics of the population at large 4
Using insights from clinical trial data to improve RWE studies, insights
Characterize the conditions under which RWE should be considered as reliable and valid as evidence from completed/ published clinical trial data
Helps define a more relevant network study or RWE analysis
sourced from group outside of use-case-thon 5
RWE as validation data set for confirming, enhancing or forming human biological characteristics for a virtual patient cohort in in silico clinical trials, which could extend to predicting how types of patients may respond to a drug or intervention. Perform an in silico clinical trial on a purely RWE data set, using cohort definitions or other insights from the clinical trial and applying it to the RWE dataset with no data linking or joining necessary.
Our #19 and 20, and also sourced from group outside of use-case-thon 6
Using RWE informatics to host & analyze clinical trial data to improve future action
Use RWE common data model to store/ protect/ standardize cohort definitions at national or organizational level (or other meta- information) to apply to all clinical trials to better enable aggregate or population-level cross-trial analytics
Identify insights from clinical trial data
{or consider a better value desc]
Our #18
Please contact with questions.

2. Use of RWE data retrospectively
Use Cases at the intersection of Real World Evidence/ OHDSI and Clinical Trials #
Type
Name
Description
Data 7
Using RWE informatics to host & analyze clinical trial data to improve future action
Add many completed clinical trials and combine them into a single ‘synthetic’ trial in a common model to perform an in silico clinical trial
Identify insights from clinical trial data
Our #9 8
Add many completed clinical trials in a common model to perform faster, more efficient analysis on outcomes and operating characteristics, toward future trial design
Helps design a better trial
Maybe our #9, maybe original 9
Add many completed clinical trials in a common model to perform faster, more efficient analysis on outcomes and operating characteristics, toward comparing single trial to a pool of historical trials 10
Use of RWE data retrospectively
Analyze RWE data to evaluate if clinical trial results were generalizable; mapped to patient behavior; the level of effectiveness to what a trial showed for efficacy, other post hoc analysis porting trial result to real world evidence
Our #10 11
Using insights from RWE data to help clinical trial design or evaluation
Identify alternate treatment arms to include in a trial by mining RWE to find off-label uses for a pathology of study
Our # 11 12
Use what RWE data can tell us about burden of disease to predict recruitment during trial to estimate sample size needed, including as specific as select cohort definitions, geographies, other
Our #3, #5
Please contact with questions.

3. Use Cases at the intersection of Real World Evidence/ OHDSI and Clinical Trials#
Type
Name
Description
Data 13
Using insights from RWE data to help clinical trial design or evaluation
Use RWE data and its patient behavior patterns to predict adherence during trial to estimate sample size needed
Helps design a better trial
(some portion of #2) 14
Understand dosage effects & patterns to educate on best trial dose ranges
Our 21 (uses 1 data set to help the other), and 12 15
Search RWE data to validate or predict endpoints or defined outcome measurements (and predict how certain types of patient might respond to a drug)
Our 22 part 2 (uses 1 data set to help the other) but not 20 as 20 is in silico, and 12 16
Search RWE data to establish the ‘standard of care’ for new clinical trial
Our 22 (uses 1 data set to help the other) 17
Using insights from clinical trial data to improve RWE studies, insights
Search a number of clinical trials to extract a universal cohort definition for a RWE study
Helps define a more relevant network study or RWE analysis
Our 23 (uses 1 data set to help the other) 18
Using matching or linking technology, identify clinical trial participants for whom there is a record in a RWE database, and add trial data about that participant to the fixed RWE dataset, or to join with RWE data during an analytic exercise
Answers health outcomes question(s)
Sourced from our group outside of use-case-a-thon
Please contact with questions.