Prepping for flu season
By: Sylvie Dupin, PhD | December 27, 2016
On dealing with the unpredictability of seasonal studies.
Every year when the flu season arrives, news media outlets clamor to report on the latest trends – will it be a mild or severe season? Where are the outbreaks clustered? What strain is most predominant and was the flu vaccine designed to address it? Unfortunately, the same questions that fascinate the public frustrate the clinical research teams tasked with planning and implementing seasonal flu trials.
Seasonal trials are uniquely challenging for a lot of reasons. Enrollment is limited to the duration of outbreak, which shifts every year; and sites ideally should be selected based on the location of patients, which is impossible to predict.
The high rate of uncertainty coupled with the very short window of opportunity means seasonal study sites need to be ready to go on day one, with the necessary start-up approvals, contractual obligations, infrastructure, training, materials, and recruiting strategies in place to begin assessing and onboarding patients as soon they get the green light.
This isn’t easy to do, but we have identified several strategies that can help expedite this process.
Tap into existing site networks. We are constantly expanding our network of sites, and collecting data about their capabilities, experience and training. Having a broad network of vetted sites to choose from is critical for seasonal studies, because every aspect of the site selection process needs to align with the needs of the outbreak to deliver the best results. It is not enough to select a site with previous seasonal trial experience. The sites we choose also need to have adequate staff resource to manage potential peaks, and the capability to complete all start-up activities in due time, get all the equipment, materials and connections to effectively recruit patients for this year’s flu season. If any one of these aspects is missing, it can delay site activation and set the site or even study up for failure. The data we continuously gather also helps us understand why sites succeed or fail in a particular study so we can make better decisions in the future. If, for example, a site failed to meet enrollment goals because the outbreak quickly died out, we can assess them differently than a site that failed because staff weren’t ready to treat patients, or their outreach efforts were insufficient.
Provide sites with everything they need to succeed. Before flu season even starts, we develop recruiting strategies, including advertising posters, brochures and other messaging, and training programs for call centers to support recruiting for sites as soon as they are selected. Having these materials in-place helps sites ramp up more quickly, and identify the best strategies in their local area including with support of established networks for recruiting patients.
Surveillance data. To help us stay on top of circulating flu and better forecast site activity, we closely monitor local and national reports of cases and also discuss with our investigational sites every week, which allows us to proactively react and ensure sites start enroll as soon as flu is confirmed in a particular region, country or city.
Work with sponsors sooner and more collaboratively.The more up-front planning time we have, the better we are able to get our investigational sites ready to enroll when flu season begins. By partnering with sponsors as early as possible on these projects, and bringing vendors and site leaders into the planning sessions, we can be sure our sites have everything they need to get started. With so much uncertainty, these studies cannot be successful without strong collaboration. Working closely as partners allows us to streamline our efforts, which increases everyone’s ability to meet their goals. Nobody can predict where/when/how the flu will be, but as a collaborative team (sites, CRO & sponsor) we can ensure to be ready on time!