Therapeutics case studies

A prominent medical device company was conducting a feasibility study for a device to improve accurate identification of peripheral pulmonary nodules in high risk adult patients. Quality imaging data from multiple sources was critical to the study’s success and ICON helped manage the imaging data for each participant.

To ensure continuity of care for participants in the maintenance phase of multiple parent studies in oncology managed by ICON and third-party vendors, a consolidated long-term extension (LTE) protocol was required.

An oncology study involving 53 parent protocols - each with distinct timelines, sites, databases, and reporting requirements - needed to be integrated into a single open-label extension (OLE) study.

A large multi-year IVD colorectal cancer study faced enrolment challenges across 180+ sites and 28,000 participants. The sponsor turned to ICON’s Medical Device and Diagnostic Research team to uncover root causes and implement effective recruitment solutions.

ICON supported five global IVD studies on rapid colorectal cancer diagnosis, enrolling over 29,000 patients across 250+ sites. Each study had unique needs, and ICON managed key functions including project management, monitoring, data handling, and site oversight.

A large pharma company submitted a New Drug Application for a targeted therapy treating a rare tumour subtype. To support safe use, a companion diagnostic PMA was filed in parallel with the FDA’s CDRH.

An international biopharmaceutical company based in the EU contracted ICON to support a new biologic drug application in Canada for an anti-cancer therapy for diffuse large B-cell lymphoma (DLBCL) under advance consideration.

A large, multinational pharmaceutical company needed to better understand patient perspectives to optimize protocol and study design and operationalise a study for TNBC.

ICON was awarded two early development cancer immunotherapy studies from a biotherapeutic company for a potentially ground¬breaking autologous cellular therapy in the treatment of two tumour types.

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.

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.