Boehringer Ingelheim expands partnership to study rare disease in real-world setting

By Melissa Fassbender

- Last updated on GMT

IPF is a rare and serious lung disease that causes permanent scarring of the lungs. (Image: iStock/Guschenkova)
IPF is a rare and serious lung disease that causes permanent scarring of the lungs. (Image: iStock/Guschenkova)

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Boehringer Ingelheim (BI) and the Duke Clinical Research Institute (DCRI) have expanded their partnership to create the largest patient registry for idiopathic pulmonary fibrosis.

The expansion increases study enrollment in the Idiopathic Pulmonary Fibrosis – PROspective Outcomes (IPF-PRO) Registry from 300 patients at 18 study sites, to 1,500 patients at approximately 45 sites, creating what BI and DCRI claim is the largest registry of newly diagnosed IPF patients.

The registry was launched in June 2014 as the first multi-center longitudinal disease state registry in the US focused specifically on IPF.

The collaboration with BI grew as an innovative academic industry partnership drawing upon expertise among the medical affairs team at BI and experience coordinating multicenter research including registries in rare diseases at the DCRI​,” Scott Palmer, MD, director of Pulmonary Research at the DCRI, told

Palmer added that the partnership is focused upon BI and DCRI’s mutual interest in better understanding the outcomes of patients with IPF in the real-world clinic setting, “rather than a narrowly defined clinical trial population​.”

As part of the expanded collaboration, Boehringer Ingelheim and the DCRI have agreed to develop the IPF-PRO Registry based on insights gained from the first 300 patients enrolled. Both also cited the growing need for diverse, real-world data to understand IPF disease progression, disease history, patient-reported outcomes, and disease biomarkers.

The largest patient registry for idiopathic pulmonary fibrosis

Certainly building a registry this large in a rare disease presents many challenges​,” said Palmer.

However, he said the DCRI is experienced in coordinating registries of many sizes and across various different patient populations.  

The study size is a potential challenge that we have successfully mitigated through our experience and collaborative relationships with many sites and their PIs that are experts in the field of IPF and other lung disease​,” Palmer added.

This has allowed DCRI to enroll more than 400 patients across the current 18 enrolling sites. The institute will continue to leverage this experience as it expands its sites up to 45 and enrollment up to 1,500.

In addition, challenges to a registry of this size include data quality and patient followup​,” said Plamer.

DCRI addressed these potential challenges by providing local on-site data monitoring as would be done a clinical trial. Palmer said this ensures data entered into the registry system is verified in the local medical records or source documents.

We have taken an innovative approach to ensure complete followup on all patients using a centralized DCRI call center that confirms patient vital status and hospitalizations independent of their followup at the local site​,” he added.

We are actively enrolling, adding sites, and beginning to use the data to develop publications that will address our primary study objectives to better understand the natural history of IPF, current treatment practices, and the disease impact on patient centered outcomes​.” 

Related topics Clinical Development

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