Therapeutics case studies

A pharmaceutical sponsor launched a global trial for elderly UTI patients, opening 125 sites across 15 countries. Enrolment lagged at 1 patient per site per month, with 70% non-enrolling. ICON was brought in to rescue the study.

A virtual biotech start-up acquired an immunomodulatory mechanism targeting inflammatory pathways. It had undergone phase 1 and small phase 2a studies. With urgency to advance development and limited resources, the client proposed two separate studies, posing challenges in complexity, timeline, and budget. The client turned to ICON to streamline development.

Over 19 days, ICON conducted a focused site engagement programme to increase patient screening and accelerate enrolment of a late phase multinational, multicentre study to evaluate a treatment for pulmonary disease.

The FDA advised the trial to re-adjudicate so that the study accounted for the effects of COVID-19 on the trial outcomes. To ensure that the trial data would be submitted to the FDA as scheduled, ICON needed to coordinate re-adjudication of 700 endpoints within a compressed three-month timeline.

ICON had he objective to develop a smartwatch mobile app combination that can be used to alert patients, and physicians and drug development teams to physical behaviours that may exacerbate patients’ pain.

A Biotech client contracted ICON to conduct a Phase III study that was a double-blinded, randomised, multinational, multicentre, placebo-controlled trial.

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.

Sponsor proposed a randomized, open-label, multi-centre, parallel-group study comparing the safety and efficacy of STUDY DRUG with Novolog in type 1 diabetes (T1D) patients.

A sponsor conducting an international Phase III program of two double-blind, randomised studies consulted ICON’s respiratory experts for assistance in patient enrolment, and study planning and monitoring.

ICON was contracted to conduct an early-phase clinical trial in Huntington’s disease across 12 countries and 53 sites.

ICON provided full-service support to a large biotech company in two global Phase 3 trials for a gene therapy product treating spinal muscular atrophy (SMA), a rare but serious condition causing muscle wasting and weakness.