Arbor Research Collaborative for Health is proud of its role as the Data Coordinating Center for the Worldwide Integration of Natural History Databases for Primary Sclerosing Cholangitis (WIND-PSC)​ study, a groundbreaking research initiative led by PSC Partners and PSC Partners Canada. These patient-led non-profit organizations are dedicated to supporting education and research in primary sclerosing cholangitis (PSC), a rare and life-threatening chronic liver disease. PSC is a severe condition that can lead to cirrhosis, liver failure, liver transplant, or death. Patients with PSC often experience significant symptom burden and a compromised quality of life as their disease progresses. Currently, no regulatory-approved therapies exist for PSC, making the development of new treatments exceptionally challenging due to the rarity of the disease.

The primary aims of WIND-PSC are:

• Develop a prospective real-world data cohort to support the design of PSC clinical trials and regulatory filings for new treatments.
• Evaluate key biomarker data by collecting bio-samples to establish acceptable endpoints for use in clinical trials.
• Assess patient-reported symptoms and quality of life using standardized tools to determine changes with disease progression.

The study recently enrolled its first participant and will recruit approximately 2,000 more participants, collecting comprehensive clinical, biomarker, and patient-reported data about the progression of PSC and its associated symptoms. Arbor Research provides key clinical trial services and supports the study’s design and implementation as the data coordinating center. The WIND-PSC study is being implemented in 20 sites across North America and Europe.

“Arbor Research has a rich history of serving as the data coordinating center for a variety of studies. We are experienced and skilled in generating critical data that will accelerate the development of new treatments for PSC patients. Especially important for the WIND-PSC project are workflows for study event classification and for biosample management integrated into our ArborLink electronic data capture system”, says Lisa Henn, PhD, Senior Research Scientist and Principal Investigator for WIND-PSC at Arbor Research.

Participants will be followed for up to five years and will undergo annual assessments including physical exams, lab tests, imaging, liver stiffness assessment, and fibrosis biomarkers. Additionally, clinical symptoms and events, medications, procedures, and patient-reported PSC symptoms will be evaluated quarterly. The data collected through WIND-PSC will provide a rich and novel source of information to be shared widely with the PSC research community, aiming to facilitate the development of effective treatments for this devastating disease.