Understanding the Seasonality of Clinical Trials
Most people think of the seasons in terms of the standard farming seasons: spring, summer, autumn, and winter. In the spring months, farmers plant their crops. In the summer, they nourish and protect these fledgling crops as they grow into adulthood. In autumn, the crops are harvested and stored or sold. In winter, finally, the farmers have some rest. Similarly, clinical research also has its seasonality, particularly for studies of diseases with seasonal surges, such as cold and flu, seasonal allergies, and certain illnesses related to infected soil or water.
From 2020 through much of 2022, the focus on infectious diseases was mainly on the year-round, highly communicable SARS-CoV-2 pandemic. As the pandemic’s peak subsided and people relaxed their prophylactic cautions, we experienced a record influenza season in December 2022. Consequently, we saw a resurgence of clients interested in bringing novel upper respiratory infection diagnostics through the FDA regulatory process.
Unfortunately, many clients wait until the cold and flu season is imminent before seeking engagement with a clinical research organization (CRO). The start of the cold and flu season (October in the Northern Hemisphere) is too late to engage a CRO, as clinical trials require detailed planning. For products intended to diagnose seasonal illnesses like upper respiratory infections, it’s best for sponsors to “plant” the idea with the FDA in spring by getting feedback via pre-submission.
Clinical Trial Start-up and Execution: Timing is Key
Summer is the time to engage your clinical research partner organization to begin start-up and “nurture and grow” your clinical program so that you can “harvest” your study results through active enrollment and testing in the autumn and winter months.
Early start-up phase tasks in a clinical trial include site identification and contracting, protocol development and institutional review board (IRB) review, and data management planning and database design and development. For a simple study with a clear and detailed clinical plan and minimal case report form/data capture requirements, these tasks can be accomplished in as few as 2 months. For more complicated studies or those requiring more overall plan development, a 3 to 4-month start-up period may be necessary.
Working backward from the official start of flu season in the US in October, the latest a sponsor should engage in start-up activities for cold and flu season-related products is August. Ideally, a sponsor would be ready to start enrollment in September to catch the earliest cases, bringing the kick-off of study start-up back into July. If a sponsor were to engage a partner in September or October to run a study for a flu diagnostic product, they would likely miss the entire first half of the season, making it less likely to meet enrollment goals and potentially forcing alternative enrollment strategies.
Choose the Right Clinical Research Partner for Seasonal IVD Studies
In June and July, while the general public is planning summer barbecues, vacations, and weekends at the beach, the clinical research team at DCN Dx is ready to start working on your clinical study to ensure a kick-off on “Opening Day” of flu season. Remember, “To everything, there is a season,” and planning is crucial for the timely execution of seasonal clinical trials.
About DCN Dx
DCN Dx is a global leader in the design, development, and manufacture of point-of-use diagnostics. Based in Carlsbad, California, our multidisciplinary team of scientists and engineers collaborates to create and integrate comprehensive assay systems, consumables, and instruments tailored for point-of-use applications. These reliable systems empower users to detect and quantify biomarkers and pathogens, thereby facilitating the timely delivery of treatments.
Our comprehensive clinical validation processes and strategic regulatory planning will ensure your project is fully compliant and on track for success. To learn more about our clinical research services, click here.
