Article
The landscape of pediatric clinical trials has evolved significantly over recent years, driven by innovations in technology, ethical considerations, and a deeper understanding of pediatric physiology. Historically, children have been underrepresented in clinical research, leading to a lack of data on the efficacy and safety of many treatments in younger populations. However, recent advancements are changing pediatric clinical trials for the better, ensuring that pediatric patients receive the most effective and safe medical care.
Pediatric clinical trials present unique challenges, especially in terms of blood collection. While the need to monitor patient safety and drug efficacy necessitates frequent blood sampling, the volume of blood that can be safely collected from pediatric patients is limited. Traditional blood collection methods often require larger volumes than necessary, which can pose significant burdens on young patients and complicate ethical approvals for clinical trials.
As published in an article on the challenges of conducting clinical trials in children by the National Library of Medicine, “the challenges to quantitative modeling in the pediatric population essentially center on the ability to do more with less.” In other words, “the number of subjects, number of measurements, and size of the measurement in terms of blood volume will all generally be reduced for pediatric studies compared with studies in adults for a similar compound.”
Additionally, in pediatric clinical trials, the volume of blood collected must be carefully controlled to ensure patient safety. Excessive blood collection can lead to anemia and other complications, particularly in young children. Despite this, the blood volumes collected are often dictated by the availability of blood collection tubes, which are typically designed for larger volumes than needed for specific tests. This mismatch leads to unnecessary blood wastage and potential inaccuracies in test results due to incorrect blood-to-anticoagulant ratios.
The COVID-19 pandemic exacerbated this issue as suppliers rationalized their blood tube catalogs, discontinuing many smaller-volume tubes. Consequently, the smallest and most vulnerable trial subjects often have to endure greater blood draws than necessary, complicating the ethical considerations of the trials.
Fortunately, recent introductions of tools such as the Greiner MiniCollect system have offered a promising solution to these challenges.
The Greiner MiniCollect system represents a significant advancement in pediatric clinical trials by addressing the need for smaller blood volumes. This innovative system utilizes capillary blood collection, which is less invasive and requires a smaller volume than traditional venous blood collection methods. The MiniCollect blood collection tubes are specifically designed to maintain appropriate blood-to-anticoagulant ratios, even with small volumes, ensuring accurate test results.
For instance, a volume of 0.5 mL collected into an EDTA MiniCollect tube is sufficient for a complete blood count (CBC) panel with differentials. Similarly, 0.8 mL in a MiniCollect SST tube is enough for a comprehensive clinical chemistry panel. This marks a significant reduction from the traditional 3.5 mL required for these tests to just over 1 mL, minimizing patient burden and wastage.
Implementing the MiniCollect system in pediatric research studies involves a shift in practice for phlebotomists accustomed to larger volume collections. Despite potential resistance, the benefits are substantial. Minimizing blood volume collection reduces the physical burden on pediatric patients and allows for more flexible clinical trial designs. This flexibility can facilitate the inclusion of additional analytical procedures within the limited blood volume available, enhancing the overall quality and comprehensiveness of the trial data.
Moreover, the reduction in blood volume requirements can improve the feasibility of obtaining ethical approvals for pediatric trials. Ethical committees often scrutinize the risk-benefit ratio of clinical trials, and the ability to demonstrate minimized patient risk through reduced blood collection volumes can be pivotal in gaining approval.
When considering a central lab for your pediatric clinical trial, it’s important to research to ensure they have the right tools for the job. At ACM Global Laboratories, we know the adoption of the Greiner MiniCollect system in pediatric clinical trials is a critical advancement that aligns with the ethical and practical demands of modern medical research. By allowing for accurate testing with minimal blood volumes, this system reduces the burden on young patients and enhances the efficiency and flexibility of clinical trials. This is why they come as a standard component to all of our pediatric clinical trials.
As the clinical trial landscape continues to evolve, innovations like the MiniCollect system will play a vital role in ensuring the safety and efficacy of treatments for the pediatric population.
