Service Description

CTI provided all clinical trial and study management services for a Phase 1 first-in man trial in patients with NASH with advanced fibrosis. they also provided for regulatory support, bioanalytical analysis, safety monitoring and reporting, site monitoring, data clean up and reporting. CTI also assisted us iby providing services related to planning for Phase 2 and is likely to participate in several of our Phase 2 trials.

What Went Well

Initial sites were brought on board quickly. Site contracting processes and IRB approvals were handled efifciently. CRO rapidly provided for turnaround on site contract and site cost negotiations. CRO established new sites to boost enrollment speed when it became clear that the initial sites were not enrolling fast enough and as we expanded the number of patients in each of the sequential dosing cohorts. CRO was very flexible to changes that were implemented rapidly as we sought to gain new information. When it became clear that PPD bioanalytical only did analysis but not pK parameter calculations, CTI jumped in and rapidly provided qualified services to calculate the pK data for us. CTI and its various subgroups are really flexible and adaptable to changes and do so quickly.

What Could Be Improved

Adherence to timelines and better estimates of rates of enrollment given that the initial sites they had worked with before (albeit for a different type of patients/indication). Original projections on site enrollment estimates were missed. CRO also did not have capabilities for an integrated central and bioanalytical lab which could handle the numerous biomarkers in this trial. We did not realize this until decision had been made to go with CTI. This required us to find a lab and oversee the lab; we would have preferred if the CRO could have provided one stop shopping and managed all peripheral activities.

Lessons Learned from the Experience

Academic sites are notoriously slow enrollers; need to give greater consideration to private sites/clinics with experience in Phase 1 trials. Probably in retrospect we should have planned for more sites and given greater consideration to using non-academic sites. The data interface from the central lab to the CRO was always a constant source of extra effort. Greater attention should be paid to the data interfaces and data formats from 3rd parties to the CRO including perhaps testing these interfaces earlier on in the process.