Prioritising efficiency and flexibility in safety data signal detection

A small US-based pharmaceutical sponsor sought ICON’s expertise to conduct ongoing safety signal detection and signal management during the clinical development of 4 different compounds studied in phase 1 to 3 trials for neurodegenerative disease. The sponsor required an efficient and programmatic solution to signal detection review to accommodate their growing clinical development portfolio.

ICON worked in close collaboration with this sponsor for four years, conducting signal detection for a variety of indications, including: Alzheimer’s disease, frontotemporal dementia, and amyotrophic lateral sclerosis.

The sponsor had limited pharmacovigilance resources available and minimal signal detection experience. Another CRO was working in tandem with the sponsor on this project, which impacted the project’s timeline. To move forward, ICON required data outputs from the other CRO’s various electronic data capture (EDC) systems. However, sometimes the data delivery was delayed which added time pressure to the project, with important milestones drawing near.

ICON did not have direct communication channels with the other CRO, necessitating all interactions to be routed through the sponsor. This frequently led to communication delays and inconsistencies in data structure, placing additional time constraints on the ICON team to rectify these challenges and adhere to our project timelines.

ICON implemented the use of our custom safety data analysis tool, SIGNET, to review the client’s investigational product safety data for safety surveillance and identifying potential signals. The implementation of SIGNET allowed for a more streamlined and efficient review of clinical trial data from the sponsor’s EDC systems, labs and other applicable data by using programmed standardised safety visualisations for each study. ICON was flexible to customise the visualisations as required for signal characterisation as more data was available.

ICON exercised its flexibility and efficiently developed resources to compensate for the external delays. The customised central template developed by ICON allowed the sponsor to adjust their view of the data depending on protocol needs by modifying visualisations for areas of interest.

Throughout the Signal Detection cycles conducted, ICON used the Orbit® tool for tracking of signals, which ensures inspection readiness. The outputs from Orbit® were easily exported and shared with the sponsor.

The sponsor provided positive feedback on the utilisation of SIGNET and the final signal detection reports. Following this feedback, the sponsor asked ICON to assist with expanding the program to include additional new product signal detection services.

“We would like to take the opportunity to thank ICON for the excellent support provided for Patient Safety activities since the beginning of our parnership. It has been a pleasure working with the Pharmacovigilance Specialised Services team from ICON.”