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  1. Oncology Center of Excellence

Leveraging Real-World Data to Investigate the Natural History of Rare Cancers Treated in the US Community Oncology Setting to Provide Clinical Context to Inform Future Research

External Institution: Ontada/McKesson 

External Collaborators: Amy O’Sullivan, PhD; Joseph Dye, PhD, RPh; Nicholas Robert, MD; Zhaohui Su, PhD; Alisha Monnette, PhD, MPH; Junxin Xi, PhD; Robert Reid, MD; Melanie Bamberg, MHA

FDA Collaborators:  Martha Donoghue, MD; Sonia Singh, MD; Catherine Lerro, PhD, MPH; Fatima Rizvi, PharmD; Donna Rivera, PharmD, MSc

Project Start Date: November 2023

Regulatory Science Challenge

Characterizing the natural history of patients with rare cancers, including the disease course, treatment course, and response to treatment, poses a considerable challenge for a wide range of stakeholders, including researchers, patients, healthcare providers, pharmaceutical developers, and regulatory bodies. A significant portion of patients with cancer receive treatment and care within community-based healthcare practices, which are often closer to their homes than large research hospitals. Between 10-15% of patients in the US are treated by healthcare providers in the US Oncology Network. This Network uses the iKnowMed electronic health records (EHR) system, which is especially designed for cancer care. This EHR provides a valuable source of information for studying rare cancers in the real-world setting.

Project Description and Goals

In this project, Ontada will use real-world data (RWD) from iKnowMed EHR to study the natural history of patients with rare cancers in US community cancer practices and compare results with other data sources such as national cancer registries, to gain a comprehensive understanding of how best to interpret these findings. Ten rare cancers will be selected for evaluation, with input from cancer patient advocacy groups, clinical experts, and FDA experts. For each selected rare cancer, Ontada will evaluate patient and clinical characteristics at diagnosis, treatment patterns, long-term clinical outcomes, and survival following the rare cancer diagnosis. The findings from this project will facilitate a better understanding of oncology patient care in the community setting for rare cancers and may inform trial design to better study possible treatments for rare cancers.

Further Information

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