Allergic rhinitis
Case study
Overcoming patient enrolment challenges.
Challenge
A Biotech client contracted ICON to conduct a Phase III study that was a double-blinded, randomised, multinational, multicentre, placebo-controlled trial. The study aimed to demonstrate the clinical efficacy and safety of subcutaneous immunotherapy in patients with Pollen-Induced Allergic Rhinoconjunctivitis. There were a number of challenges to this study including; country limitations due to budget restraints, high threshold criteria for target population, clinical/skin prick test (SPT) supply issues, eDiary data transfer, IgE testing requirements and a high volume patient recruitment requirement.
Solution
ICON selected a number of high performing sites and encouraged them to select their moderate to severe patients in advance through a pre-screening process. A total of 70 active enrolling sites were selected for this study which included; Belgium (5), Czech Republic (7), France (2), Germany (25), Hungary (7) and Poland (24). The number of screened patients amounted to 802 and randomised patients to 657. Patient enrollment benefited from a high level of patient motivation due to lack of available treatments in the market. This also resulted in a low screen failure rate with the most common reason being that patients had IgE values that were too low or that higher skin test measurements were required. Recruitment metrics were monitored closely with ongoing review of data and a database cleaning activity across various vendors. A customised patient recruitment strategy was developed that addressed the unique needs of this type of trial.
ICON’s value add
- Pre-Screening - This is typically important in allergic rhinitis where the allergen testing and IgE values are significant factors although not necessarily associated with disease severity. A low screen failure rate obviously helps patient recruitment and it is important to find incentivised patients. This study highlighted the significance of very low screen failure and dropout rates in the allergic rhinitis population.
- Risk Management - Strong contingency plans were put in place for initiating sites as few back-up sites were approved. Patient recruitment initiatives were devised to drive recruitment and deliver ahead of time to overcome strong competition from other clinical trials.
- Strong vendor collaboration - Strong communication and collaboration across the companies in terms of testing requirements, electronic systems and data capture, and clinical supplies management led to positive outcomes. Ongoing communication with
the customer and the various contracted vendors enabled ICON to overcome country and clinical supplies challenges. - ICON has experience in providing feasibility, start-up, project management, clinical monitoring, data management, statistics and medical monitoring for global phase III allergic rhinitis studies.
Outcome
After adopting ICON’s solution for this trial, patient enrollment was completed twice as fast as with other similar trials. Due to this the study timelines were achieved in line with allergy season. Screen failure and recruitment rates were largely similar across the countries. Belgium had the highest screen failure rate at 31% compared to the average of 18%. Hungary also had good recruitment performances. Other countries were high performing and resulted in an average screening rate of 8 psm. These factors helped reduce the screening period from the targeted 3 months to 6 weeks.