Application of machine learning methods to bridge the gap between non-interventional studies and randomized controlled trials in ophthalmic patients with neovascular age-related macular degeneration

Alexandros Sagkriotis, Usha Chakravarthy, Ray Griner, Orla Doyle, Tim Wintermantel, Andreas Clemens

Research output: Contribution to journalArticlepeer-review

2 Citations (Scopus)
11 Downloads (Pure)

Abstract

Purpose: The effectiveness of intravitreal anti-vascular endothelial growth factor agents is usually lower in real world settings compared with randomized clinical trials (RCTs), often limiting the use of real-world evidence (RWE) in regulatory and healthcare decisions. The current analysis aimed to develop and validate an algorithm to explain the difference in outcomes between RWE studies and RCTs in patients with neovascular age-related macular degeneration.

Methods: The algorithm was developed using ranibizumab real world data (RWD) from the US and validated on Australian and UK RWD. A decision model was developed using machine learning principles, in which the model learns how to partition the most influential factors (out of 59 variables) so that they maximally relate to the change in visual acuity (VA) over 12 months.

Results The algorithm identified baseline VA

Conclusion: Machine learning techniques can be used to classify real world cohorts and identify subsets of patients who benefit to the same extent as that reported in RCTs. This methodology may support the translation of clinical trial findings to treatment performance in the clinical practice setting.
Original languageEnglish
Article number106364
JournalContemporary Clinical Trials
Volume104
Early online date18 Mar 2021
DOIs
Publication statusPublished - May 2021

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