Therapeutics case studies

The PAC19 VCN digital droplet (dd)PCR test was validated by ICON to detect and monitor CAR-T (chimeric antigen receptor) cell expansion and persistence in patients receiving anti-CD19 CAR-T therapies.

A study sponsor was investigating a biological treatment for oncology patients in addition to the standard of care chemotherapy. They sought regulatory support from ICON due to the study’s complexity, the geographic span and because the IVD was used out of its intended purpose.

Explore how ICON successfully supported a sponsor’s cardiovascular outcome trial for a GLP-1 receptor agonist with 9,900+ patients with type 2 diabetes and maintained a retention rate of 97% over 7 years.

"A large pharma customer sought expert regulatory support from ICON for a paediatric rare disease development
program."

The sponsor in this case was a large pharmaceutical company that contracted ICON to manage and streamline the training and compliance workload for their phase 2 Alzheimer’s study.

ICON conducted a multinational biosimilar phase 1 study for multiple sclerosis (MS). This trial was performed under high regulatory scrutiny and challenging pandemic conditions, with increased dosing targets requiring additional site activation.

ICON conducted a multi-centre study to assess the efficacy, safety, and tolerability of an anti-α-synuclein human immunoglobulin G1 monoclonal antibody in patients with Multiple System Atrophy followed by an open label extension.

ICON operationalized a hybrid decentralized clinical trial for participants experiencing bothersome Vasomotor Symptoms (VMS).

A digital health lead at a large pharmaceutical company came to ICON Outcome Measures to find a wearable that could capture continuous cardiac rhythms and be used to detect QT prolongation.

ICON partnered with a biotech sponsor to optimise Case Report Forms (CRFs) for an oncology cell and gene therapy trial. By adopting iRECIST criteria and standardising CRF templates, we reduced data duplication, ensured accuracy, and provided flexibility for subject re-treatment.

A complex oncology study in multiple myeloma cancer experienced a 30% higher than anticipated enrollment rate, leading to a large data backlog. Learn how ICON implemented global remote monitoring to address the backlog and manage ongoing data volume.

This case study explores two Bayesian model-assisted designs in the context of early phase oncology clinical trials, focusing on their application and impact on study design. It includes a review of each design’s operating characteristics, proposed amendments, and simulations.