Clinical Development: Real-World Insights to inform protocol design

Traditional approaches to clinical trial design lead to significant costs and inefficiencies, with 60% protocol amendments of which 45% are avoidable.

 

Challenges and opportunities

What’s driving the challenges?
  • Smaller patient populations and niche indications
  • More complex clinical trial end-points
  • Limited historical data (clinical trial benchmarks, epidemiological DBs)
  • Country and local care pathways variance hard to measure
  • Need to triangulate and extrapolate designs across various data sources

“Conducting feasibility in clinical trials is an investment to ensure a good study”

How can EHR¹ enable better design?
  • Understand exact incidence, prevalence and seasonal variation
  • Simulate complex protocols, end-points and relative time frames
  • Examine any disease area even with limited historical trials
  • Establish detailed country feasibility, local treatment and patient visit patterns
  • Conduct precise “what-if” analysis and receive feedback in real time

“Access to Electronic Health Records systems offers new opportunities to help our customers design better protocols”

¹Electronic Health Records

 

Using Electronic Health Records & E360™ across protocol design and trial design

¹Target Product Profile/Clinical Development Plan

 

Key capabilities available

Protocol feasibility

Assess protocol design/feasibility on global patient populations in real timeProfile and find your next real-world data assets

  • Interrogate any element of EHR data (diagnosis, drugs, labs, etc.)
  • Define complex protocols re-using existing codelists and disease definitions
  • Simulate even the most complex criteria including relative time windows
  • Instantly test across multiple countries for global feasibility

 

Recruitment feasibility

Perform recruitment simulations based on real patients

  • Understand detailed real patient visit schedules in ambulatory and secondary care
  • Validate study recruitment assumptions using historic exact patient visit schedules and seasonal schedule
  • Test “best-case” vs. “worst-case” screening assumptions on recruitment time
  • Share across teams and allow fast decisions on trial design and feasibility

 

Advanced reporting

Geo Visualization
Identification of geographically favorable sites for clinical trials

Incidence and Prevalence
Report disease incidence and prevalence on specific cohots

Attrition
Visualize the patients funnel for a specific cohort

Patient Timeline
Visualize the patient’s journey and when they become eligible and recruitable in their own healthcare journey

Data Completeness
Interpret EHR properly and understand how well key clinical variables are captured in EHR