Why centralized labs are the future of clinical trials.
Clinical trials are an essential part of drug development and regulatory approval processes. These trials require rigorous data collection and analysis to ensure the safety and efficacy of new therapies. However, conducting these trials across multiple sites can introduce variability in the data due to differences in equipment, personnel, and protocols at each site. To address this issue, many trials now use a central lab for sample processing and analysis, rather than relying on local labs at each site. In this blog post, we will explore the advantages of using a central lab for a multisite decentralized clinical trial, citing Vipin Adhlakha, the founder and President of Aria Diagnostics, a clinical trial support company.
First, using a central lab allows for consistent and standardized processes and procedures across all sites. According to Vipin Adhlakha, “standardization is key to ensuring the accuracy and reliability of clinical trial data." When using local labs, differences in equipment, personnel, or protocols can introduce variability into the data, making it difficult to draw valid conclusions from the results. However, using a central lab ensures that all samples are processed and analyzed in the same way, reducing the potential for variability in results. This can increase the accuracy and reliability of the data collected and reduce the risk of errors or discrepancies between sites.
Second, using a central lab can also be more cost-effective in the long run. According to Vipin Adhlakha,
"Central labs can process a larger volume of samples more efficiently, which can reduce costs associated with sample collection, transportation, and processing at each individual site." - Vipin Adhlakha
While using a central lab may initially seem more expensive due to the higher upfront costs of equipment and personnel, it can ultimately save time and money by processing samples more quickly and efficiently than local labs. This can speed up the overall trial timeline and reduce the risk of delays or errors caused by slow or inefficient sample processing.
In addition to standardization and cost-effectiveness, using a central lab for a multisite decentralized clinical trial offers several other advantages. Central labs are typically equipped with more advanced and precise instrumentation and have highly trained personnel, which can lead to better quality control of sample processing and analysis. This can increase the accuracy and reliability of the data collected and reduce the risk of discrepancies between sites. Central labs can also save time by processing samples more quickly and efficiently than local labs, which can speed up the overall trial timeline and reduce the risk of delays or errors caused by slow or inefficient sample processing.
In conclusion, using a central lab for a multisite decentralized clinical trial offers many advantages over using local labs, including standardization, quality control, cost-effectiveness, time savings, and consistency and comparability of results. As Vipin Adhlakha notes, "standardization and quality control are critical components of clinical trial design and execution." By using a central lab, trial sponsors can ensure that their data is accurate, reliable, and consistent across all sites, which is essential for regulatory approval and patient safety.