Why Clinical Trial Labeling is Essential
COVID-19 has demonstrated the need for clinical trials to become more global in scope to reflect the patient population better. However, the globalization of clinical trials will also create a new set of regulatory requirements that the pharmaceutical industry must address. This includes clinical labels for drug and shipping containers that are accurately translated depending on the destination. An effective labeling infrastructure can significantly reduce labeling time while also improving overall accuracy. A key to cutting labeling costs while enhancing reliability is clinical data management software that focuses on the data rather than its label. This allows for greater flexibility when country-specific changes need to be made. Here are some other areas clinical trial labeling can prove to be a benefit when setting up your clinical trial.
Drug Packaging
When deciding on product packaging, the label must also be considered. This is particularly true for clinical trials that handle a number of various products, all requiring different packaging that may be exposed to a host of diverse environments. All these factors must be duly considered when choosing the appropriate clinical labels to ensure they do not fail, as this could mean a premature end to the trial and thus its failure. Clinical trial labeling also serves as a valuable tool for tracking samples throughout the trial and keeping users informed.
The first thing to consider is the type of container being used, from plastic medication bottles and cardboard boxes to glass drug vials and medical syringes. These different surfaces might require labels for clinical trials with a slightly different adhesive to ensure they affix firmly and don’t fall off. This is also important when considering the storage and transportation conditions they will be exposed to. If the medication needs to be stored or transported in low temperature conditions, such as vaccines, the label should be able to withstand these temperatures as well as the high humidity and moisture encountered in freezers and during refrigeration. Conversely, some equipment may need to be sterilized; this will require sterilization labels that can resist elevated temperatures and the high pressure found in steam autoclaves or exposure to ethylene oxide gas. There may also be a need to use specialized clinical trial labeling solutions, such as tamper-evident labels. These destructible labels will tear-up upon any attempt to remove them, providing an extra layer of protection against theft and tampering.
Clinical Trial Labeling Time Limits
Achieving milestones and meeting deadlines is vital to the success of any clinical trial. This is easier said than done in most cases, but the use of accurate identification techniques should at the least not hinder the process and help streamline trials and help make them run smoother. The best way to ensure your labels are a help and not a hindrance to your trial is to partner with an experienced and proven label manufacturer.
An established label supplier should be able to manufacture their labels in-house. Ideally, they will also have control over their supply of raw materials. This will ensure they can maintain a tight control over the quality of their labels and provide them greater flexibility in offering labels that will meet the unique specifications required by their customers. The sign of a good label manufacturer is ISO certification, which indicates they have various processes in place to ensure they can continue to provide their labels even following a crisis or unexpected disaster. Producing their clinical trial labels in-house also means they can shorten necessary lead times of large and small orders, positioning them better to meet demanding timelines that may arise.
Patient Attrition & Other Considerations
Labels for clinical trials can also help reduce the problem of patient attrition. There are several factors at play that affect patient retention, with some estimates placing it as high as 30%. One component that can sometimes be overlooked is clinical trial labeling. Accurate and informative labels help keep participants informed and engaged, minimizing the chances of them leaving a study due to frustration or simply not understanding the proper dosage schedule.
Labels will also help address the issue of unexpected protocol deviation. Whether this results in minor, such ad updated expiry dates or significant changes to the study control group, labels must be updated and replaced as soon as possible. A label manufacturer that can quickly adapt and provide these revised labels rapidly and efficiently can make all the difference toward a trial’s success.
