Vice President, Global Head, RWE Research & Alliance Services, ICON Commercialisation & Outcomes
In traditional real-world, observational studies, only about one-quarter or so of all study sites usually enrol the majority of patients, while another 15 percent or so never enrol even one. Yet, the cost of assessing, training and activating a site, and then maintaining it for two to three months while waiting for the first patient, is the same no matter how many patients are finally recruited.
Patient-First Rapid Site Activation can greatly reduce the time and cost spent on non-performing sites by never activating them in the first place. In addition, it can accelerate study timelines by activating sites in a few days rather than a few weeks, and improve performance of successful sites by ensuring they are fully engaged with actual patients from the day they are activated.
The approach, when combined with a comprehensive site engagement model, can cut observational study costs by 30 percent to 40 percent compared with traditional methods. This highly streamlined and standardised site engagement and support model makes running real-world, post-market studies – which are increasingly demanded by regulators and payers – more financially attractive in the United States, where regulations favour such innovative study design and administration.
First patient enrolment triggers site activation
ICON developed Patient-First Rapid Site Activation to reverse the traditional approach – in which first patient enrolment can take weeks or sometimes months – by waiting until a site identifies its first patient before it is activated. The process can be completed primarily by telephone, and usually in less than a week.
Before activation, potential sites are identified and approached about participating in the study. Once a qualified patient is identified, the physician signs an abbreviated standardised contract, and undergoes final site assessment and training using pre-approved study start-up material, a pre-selected central institutional review board, and a simplified informed consent form.
ICON’s Patient-First Rapid Site Activation is well suited for late-phase observational studies because it has more regulatory flexibility and support, especially under US FDA guidelines, and lacks the stringent Good Clinical Practice requirements of Phase II/III studies. This enables the use of a lean, standardised study, site support, and administrative materials and practices.
No more non-performing sites
By waiting for an actual patient to enrol, Patient-First Rapid Site Activation completely eliminates the cost of activating and carrying non-performing sites. In addition, the streamlined and simplified activation process, supported by remote activation and site monitoring, significantly reduces the cost of administering sites that have recruited patients.
Eliminating the lag between site activation and patient recruitment also keeps sites and patients engaged, and increases the likelihood sites will enrol more patients sooner. Such engagement is further promoted through ICON’s Real-World Evidence Research Services Hub, which provides real-time support to sites through a single contact – from study launch through final data analysis – and gives patients the information and support they need to participate over the long haul.
Unique in the industry, ICON offers Patient-First Rapid Site Activation in all types of late-phase and observational studies, across all therapeutic areas.
To learn more or to speak with a late-phase expert about how ICON’s Patient-First Rapid Site Activation and hub site and patient support services can accelerate your study, contact us today.