Abstract
e13581
Background: In the past decade, immunotherapies have revolutionized oncology practice by prolonging patient survival in previously rapidly fatal cancers. However, severe immune toxicities present a challenge, affecting ̃20% and up to 50% of patients on immune monotherapies and combination immunotherapies, respectively. Oncologists must balance toxicity risk with potential efficacy, and pharmaceutical companies have a vested interest in selecting patients with the highest benefit–risk ratio during trial enrollment. Predictive toxicity–efficacy modeling has the potential to guide trial subject selection and clinical care, yet there remains a need for predictive models that can be practically implemented in these settings. Methods: A common academic–industry contract data–transfer framework—wherein academic medical institutions and industry counterparts act in isolation—creates barriers to development of high-quality algorithms with practical applications. In this framework, 1) academic medical institutions provide patient data as a “data dump;” these data are static and cannot be refined—reducing opportunities for quality control; 2) predictive model outcomes may include artifacts that are not identified; 3) manual curation of patient data is required to accurately replicate the model in real-world settings; and 4) lack of clinician participation reduces the potential clinical applications of models and reciprocal benefit to the academic institution. We outline a more contemporary, engaged approach to unite strengths of both partners to achieve a common goal. Results: In 2019, Vanderbilt University Medical Center and GE Healthcare partnered with the goal of enabling safer and more precise immunotherapy use. As part of this work, we formulated a recipe for academic–industry partnerships that offers unique advantages over a static contract framework. In our iterative, interactive approach, 1) clinical and curation experts meet with industry modelers to dynamically refine deidentified data sets by resolving discrepancies in data from different sources (e.g., manually curated vs. structured data); 2) clinical experts iteratively review outputs of predictive models to identify potential artifacts and refine final models; 3) expert curators iterate with in-house machine-learning experts to create algorithms to automate curation of natural language elements from the identified EHR data; and 4) clinical and industry stakeholders participate in regular meetings with modelers to ensure clinical and trial utility of the modeling approach. Conclusions: Compared to data transfer-only relationships, this partnership framework offers an opportunity to develop more informed, higher quality immunotherapy models with clinical and industry applications.