C-Path Receives Data Transfer from Network of Hospitals in Japan

The data transfer is a first from the country and currently includes data from three hospitals

TUCSON, Ariz., December 7, 2022 — Critical Path Institute has received properly anonymized electronic patient record (EPR) data from three hospitals in the Neonatal Research Network of Japan — Nagano Children’s Hospital, Kyorin University and Osaka General Hospital. The collaboration comes from partnering with leading pediatric neonatologists, Dr. Tomohiko Nakamura, Dr. Kenichiro Hosoi and Dr. Hiroko Iwami at each site, respectively.

It is the first time C-Path has received EPR data from Japan and is part of efforts to better understand and find treatments for a chronic lung disease which frequently affects premature infants. The initiative, funded by a grant (U01FD007220) from the U.S. Food and Drug Administration (FDA), is being executed through a neonatal pilot project within C-Path’s International Neonatal Consortium (INC).

“This is a significant milestone in international collaborative research from the Neonatal Research Network of Japan,” said Dr. Satoshi Kusuda, M.D., Department of Pediatrics, Kyorin University, Tokyo. “The EPR data, coupled with previous clinical trial data transfers within INC, will shed new light on developing drug therapies for neonates and understanding the causes of death and disability among babies born prematurely.”

The EPR data shared by Japan will be integrated with other patient-level real-world data national registries and networks, as well as clinical trial datasets contributed by INC industry members. The transfer received ethics approval from the participating hospitals, and none of the data can be traced back to individual patients.

The data transfer includes more than 15,700 fully anonymized patient-level records to be used to understand how the lung condition bronchopulmonary dysplasia (BPD) develops in premature infants. The aim is also to identify stages when doctors can intervene to reduce the risk of BPD, to help find treatments, and to help understand the long-term effects of BPD. The data will also be used to generate neonatal laboratory value normative ranges.

The generation of these real-world evidence solutions is led in partnership between INC and C-Path’s Quantitative Medicine Program with support from its Data Collaboration Center. C-Path’s INC Executive Director Kanwaljit Singh, M.D., MPH, added, “C-Path has extensive experience in real-world data project collaborations, and we’re pleased to welcome the Japan data into this initiative. It’s clear that there is a global unmet need in neonatal drug development and this important collaboration will help to accelerate treatments.”

C-Path’s INC will continue to partner with collaborators and new data contributors to integrate additional patient-level datasets.

For more information on collaborating with INC, and how to contribute data, please email Christine Barry at cbarry@c-path.org.

About Critical Path Institute
Critical Path Institute (C-Path) is an independent, nonprofit organization established in 2005 as a public and private partnership. C-Path’s mission is to catalyze the development of new approaches that advance medical innovation and regulatory science, accelerating the path to a healthier world. An international leader in forming collaborations, C-Path has established numerous global consortia that currently include more than 1,600 scientists from government and regulatory agencies, academia, patient organizations, disease foundations, and hundreds of pharmaceutical and biotech companies. C-Path U.S. is headquartered in Tucson, Arizona, C-Path in Europe is headquartered in Amsterdam, Netherlands and C-Path Ltd. operates from Dublin, Ireland with additional staff in multiple other locations. For more information, visit c-path.org.

Critical Path Institute is supported by the Food and Drug Administration (FDA) of the Department of Health and Human Services (HHS) and is 55% funded by the FDA/HHS, totaling $17,612,250, and 45% funded by non-government source(s), totaling $14,203,111. The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement by, FDA/HHS or the U.S. Government.

Kissy Black