Therapeutics case studies

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.

Clinical trial participation exposes rare disease participants to significant pressure financially, logistically and psychologically, and these incremental pressures can negatively impact a patient’s ability or willingness to enrol or remain in a clinical trial.

In February 2020 ICON quickly mobilised its vaccine and infectious disease resources to assist government
and commercial clients in addressing the COVID-19 global threat.