Why are Clinical Trials Considered Seasonal?
Just as people connect seasons with farming cycles, clinical research follows its own seasonal rhythm. Diseases like cold, flu, allergies, and infections from soil or water exhibit seasonal patterns. From 2020 to a significant part of 2022, attention was on year-round infectious diseases like the SARS-CoV-2 pandemic. Following its peak, a notable flu season arose in December 2022.
Unfortunately, many clients delay involving a clinical research organization (CRO) until the eleventh hour for seasonal illnesses like cold and flu. Collaborating with a CRO in October, as the cold and flu season starts, is too late for meticulously planned clinical trials. Sponsors intending to develop diagnostic products for these illnesses would be wiser to present their ideas to the MDR during spring, seeking input through pre-submission.
Optimal Timing for Clinical Trial Start-up and Progression in Europe
As the warm months of summer arrive, it’s the ideal time to collaborate with your clinical research partner organization to initiate the start-up phase of your clinical program. This phase serves as the nurturing and growth period for your study, leading to active enrolment and testing during the fall and winter seasons, where you can reap your study results.
During the early start-up phase of a clinical trial, key tasks involve:
- Identifying and contracting sites
- Crafting the protocol
- Undergoing institutional review board (IRB) evaluations
- Planning data management, including database design and development.
For simpler studies with detailed clinical plans and minimal data capture needs, these tasks might take only around 2 months. However, more intricate studies or those demanding comprehensive plan development could require a 3 to 4-month start-up period.
Considering the official start of the flu season in the Europe during October, sponsors should work backward to determine the latest point to commence start-up activities for products related to the cold and flu season. August emerges as the cut-off, ensuring readiness to initiate enrolment in September and capture early cases, pushing the initiation of study start-up back to July. If a sponsor delay engaging a partner until September or October for a flu diagnostic study, they risk missing the first half of the season, potentially falling short of enrolment goals and necessitating alternative strategies.
Choosing the right partner for your Clinical Research
When embarking on the journey of seasonal IVD studies, the selection of an appropriate Clinical Research Organization (CRO) holds great significance. CRO’s works towards helping clients in accomplishing their research goals with efficiency and adherence to ethical and scientific standards. The alignment of timing and planning with the appropriate CRO becomes the key for successful execution of seasonal clinical trials.
The intricate choreography of these trials demands meticulous preparation, ensuring that the research timeline synchronizes seamlessly with the occurrence of relevant health events. In the end, the synergy between the right CRO and the precise moment in the seasonal cycle crystallizes into a recipe for triumph of IVD clinical research.
ECLEVAR stands out as a formidable clinical research partner, showcasing its preparedness to commence clinical studies during June and July, with a dedicated research team that is ready for a timely launch of studies as the flu season dawns.
About ECLEVAR
With its headquarters in France, ECLEVAR boasts a diverse team of scientists who collaborate seamlessly to develop and bring to market advanced diagnostic technologies by offering solutions for clinical research. Our services help manufactures with both scientific and regulatory aspects of a clinical trial.
ECLEVAR’s multifaceted approach centres on Process, Product, and People, allowing us to provide comprehensive support in adhering to mandatory ISO standards. Our seasoned team enables manufacturers to navigate quality, regulatory, and market-related challenges, ensuring that their medical devices align with industry requirements.
Whether it’s comprehensive clinical validation processes or strategic regulatory planning, ECLEVAR’s CRO services offer quality solutions tailored to diverse research needs, positioning projects for compliance and success on a global scale. To learn more about our Clinical Trial services, contact us.
