Clinical trial design for HPS pulmonary fibrosis

The National Institutes of Health (NIH) intends to award a Firm-Fixed-Price Purchase Order to Berry Consultants LLC for the development of a proposed clinical trial design for HPS pulmonary fibrosis. The goal of this project is to use available data to characterize disease progression, evaluate candidate endpoints and analysis methods, and identify a recommended design strategy for future interventional trials. • The project involves simulating a clinical trial with pulmonary fibrosis patients to provide outcome parameters and measuring endpoints. • Berry Consultants has previous experience working with the NIH's HPS cohort and has preliminary data from previous contracts. • The project aims to support the development of a proposed clinical trial design suitable for presentation to potential sponsors and for early regulatory advice.