IDENTIFYING THE CONFOUNDERS THAT EXPLAIN THE DIFFERENCE IN READOUTS BETWEEN NON-INTERVENTIONAL STUDIES (NIS) AND RANDOMIZED CONTROLLED TRIALS (RCTS)- THE CASE OF TREATMENTS IN NEOVASCULAR AGE-RELATED MACULAR DEGENERATION (NAMD)

Author(s)

Sagkriotis A1, Griner R2, Durus A1, Doyle OM3, Rodriguez Torres L1, Wintermantel T4, Clemens A1
1Novartis Pharma AG, Basel, Switzerland, 2IQVIA Real World Insights, Cambridge, MA, USA, 3IQVIA, London, UK, 4IQVIA Real World Insights, Basel, Switzerland

OBJECTIVES: The effectiveness of intravitreal anti-vascular endothelial growth factor (anti-VEGF) agents is usually lower in real-world settings compared to randomized clinical trials (RCTs). Identifying matching cohorts might bridge the gap in clinical outcomes, but there is uncertainty about which factors to include in the matching process. This study aimed to identify potential confounders that explain the difference in readouts between non-interventional studies (NIS) and RCTs in nAMD patients using an algorithm based on ranibizumab real-world data (RWD), in reference to the CATT studyresults.

METHODS: A step-wise, predictive analytics approach was applied to develop a decision model where the terminal nodes represented the most influential factors on visual acuity (VA) at the end of year 1. The decision tree used electronic medical records (EMR) data from the USA. The algorithm was validated using EMR data from UK and Australia.

RESULTS: The algorithm identified the following criteria as impactful on readouts: 1) Age>

Conference/Value in Health Info

2018-11, ISPOR Europe 2018, Barcelona, Spain

Value in Health, Vol. 21, S3 (October 2018)

Code

PSS8

Topic

Clinical Outcomes, Epidemiology & Public Health

Topic Subcategory

Comparative Effectiveness or Efficacy

Disease

Sensory System Disorders

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