BusinesNews Wire Press Release company Logo
Home BNN The Importance of Sample Tracking And Processing In Early Phase Clinical Trials

The Importance of Sample Tracking And Processing In Early Phase Clinical Trials

by Busines Newswire
0 comment

In early-phase clinical trials, the focus is typically on assessing various factors that may be impacted when using a new compound for the first time in humans. These trials are critical in developing new drugs and devices to treat various medical conditions. As such, any biological samples must be meticulously ordered, stored, tracked, and processed to ensure data reliability. That way, those taking the next steps in developing such compounds can make informed decisions.

What Is Sample Tracking and Processing?

During a clinical trial, it is likely that a variety of samples will be taken from patients and control groups, which will undergo a raft of tests. The test may involve assessing any or all of the following:

  • The safety of the compound
  • Tolerability in patients
  • Pharmacokinetics – How a drug is processed
  • Pharmacodynamics – How a drug impacts the human body

Samples can be taken and processed in various ways, including aliquoting, centrifugation, storage, and analysis. During these processes, every patient’s sample should be processed similarly. In addition, they must be given an easily identifiable and trackable marker, which will allow for practical analysis of these samples over time. 

Ensuring a robust system for tracking and processing samples is vital for any early-phase clinical trial. That way, the results can be replicated more efficiently, and the data collected from the trial can be considered viable and reliable. 

Why It Matters

There are various reasons that effective sample tracking and processing matters:

  • Integrity of data—All clinical trials aim to produce accurate, reliable data. Tracking samples means everyone is easily identified, labelled, and linked to the right patient. Any errors in this process could lead to invalid data, impacting the trial’s results.
  • Patient safety: Patient safety is paramount in clinical trials. If adverse events or reactions occur, they must be traced back to the specific patient to allow researchers to make adjustments or discontinue the prosecution.
  • Regulatory needs—The MHRA, for example, requires samples to be handled in specific ways so that it can accept the results of such trials.
  • Resources – A failure to track samples effectively means saving resources in terms of time and money.

What can be used to ensure robust sample tracking?

Previously, sample tracking relied on paper-based records and identification labels. This method was typically prone to human error, and it wasn’t easy to collaborate on trials from different places. These days, much of the data involved in clinical trials is digital, which makes it much easier to process and analyse, no matter where the researchers are based. There are now various ways in which robust sample tracking can be ensured, including:

  • Barcodes and RFID labels – Electronically generated labelling of samples has revolutionised the effective tracking of samples.
  • Laboratory Information Management – Various systems have been developed to electronically manage samples’ test results, location and chain of custody. 
  • Real-time temperature monitoring – Monitoring systems installed in temperature control units can effectively confirm that the sample has been consistently at the optimal temperature to avoid degradation. 

In the future, technological advancements in AI and automation are likely to further enhance the efficiency and reliability of sample processing and tracking, which will only benefit researchers and those participating in clinical trials.