Rare Case Study
ARG Innovates and Achieves Results
In an ongoing ARG study of a drug for a rare disease in which blinding fibrous membranes grow under children’s eyelids, a small number of patients were treated at two large referral centers in the US and Europe. The first interim analysis revealed an issue: measuring membranes manually on squirming children was producing inconsistent readings between sites, and even from the same patients at different visits.
For this trial, the potential for greater variability was not anticipated in the protocol given the lack of an established scale for fibrous membrane growth. An idea was used to require digital photographs at every patient visit. Further, a central reader was brought in to evaluate the images by measuring the lesion areas electronically.
The resulting data enabled a robust statistical analysis, supporting the study’s original lesion mass reduction endpoint. Additionally, the data highlighted differences in baseline disease states between the eyes of many patients and separate treatment responses.
ARG has lengthened its reach with the acquisition of London-based CCA Clinical.
CCA, founded in 1988 and recognized for its network of clinical research experts across Europe, has been an ARG strategic partner since 2007. The combination of the two companies creates a comprehensive, global, clinical trial management solution for small to mid-sized biotech companies.
“We now have an experienced, global team to provide a full suite of best-in-class development services to the Biotech and Pharma industry in all phases of development,” said Paul Bishop, ARG’s CEO and co-founder, adding that the acquisition is part of a process that will lead to future transactions in other countries and on other continents.
“ARG’s acquisition of CCA represents a natural next step and an exciting growth opportunity. This is a marriage of two world-class teams with a common vision,” Lyle Camblos, President and co-founder of ARG, said.
Analyzing both eyes effectively doubled the study sample, which was initially defined as individual patients rather than individual eyes. This yielded an unexpectedly detailed and valuable understanding of the relationship between disease severity and treatment response. ARG fosters collaboration among experts in clinical and research disciplines to successfully address and overcome challenges.