Data Collection for Clinical Trials

Thanks to data loggers, the temperature and humidity of products in transit can be monitored in real-time. However, there are many different kinds of data loggers on the market, from basic collection units, advanced interactive units, to software in tablet and smartphone devices.

When choosing the right data logger, kit-level indicator, or “smart” temperature indicator for your clinical studies, consider the following:

• What range of conditions or parameters need to be measured?

• Are alarm notifications necessary when the conditions go beyond the threshold?

• Does the data logger need to be waterproof, weatherproof, or able to withstand harsh environments?

• How frequently will the data be collected?

• What device(s) will be used to view the data?

• Measurement accuracy and resolution, its data access options, battery life, and software capabilities.

• Does the logger facilitate a continuous and reliable record of temperature data?

• Can the data be downloaded and stored digitally?

• Is the data applicable to analytical software that is compliant with regulations?

Data loggers record various conditions over time and store them, whereas indicators such as a temperature indicator or a kit-level indicator signals an alarm when conditions deviate from the set parameters. Indicators are appropriate because they provide strategic insight when the conditions vary, and this makes them highly effective.

Why Monitor the Temperature During Clinical Trials?

It is crucial to monitor the temperature of trial products during clinical trials. The reason being is it ensures the products remain effective and safe throughout the entire process, which runs from research and development to the distribution of the products. Humidity and temperature can have detrimental effects on clinical trial products such as trial drugs and their ingredients. The product could become less potent, ineffective, or harmful to participants.

To ensure that CROs and other stakeholders are compliant with government guidelines such as the Good Distribution Practices (GDP) and Medicines and Healthcare Products Regulatory Agency (MHRA), electronic indicators such as kit-level indicators or temperature indicators should be used. They assure the product integrity is maintained to the highest standards.

The Importance of the Stability Budget in Clinical Trials

A stability budget helps to make the supply chain of clinical trials more secure. It defines the ideal conditions as well as acceptable excursions of a product. It is a calculation of time and temperature requirements. As a product moves through the various phases of the clinical supply chain, it is possible for temperature deviations to occur. These deviations occur during loading, unloading, transit, manufacturing, packaging, or storage. The stability budget determines the duration a pharmaceutical product can withstand out of its labelled storage conditions without losing its quality, safety, or efficacy. An investigational medicinal product (IMP) is considered safe to use when there is enough remaining stability budget (RSB).

The Complexity of Temperature Monitoring 

Temperature data from a temperature indicator can be collected using USB stand-alone loggers, wireless sensor networks, web-based data systems and Bluetooth® Low Energy loggers. Since they access data differently and use various data formats, combining the said options into a single system is very complex. Idealistically, software that would be compatible with a variety of operating systems should easily merge different data formats and allow for analysis.

Temperature monitoring processes need to be compliant with GDP, MHRA, and GMP requirements throughout the phases of the clinical supply chain. The reason for compliance is to ensure patient safety. These requirements ensure the integrity of a product throughout its entire lifecycle. The difficulties in maintaining compliance are a result of a more complex process and numerous hand-over points. The manual process of compliance is not only expensive and time-consuming, it is also prone to error. Ultimately, it puts the quality of the product at risk.

Kit-Level Indicator—Your Solution

The kit-level indicator has provided a solution to monitoring the temperatures of IMPs along the clinical supply chain. Each clinical kit-is equipped with an individual electronic temperature indicator that monitors the temperature throughout the entire clinical supply chain, from the initial steps of packaging and labeling to its final use by clinical trial participants. Kit-level indicators are able to provide a more accurate reading of a product’s temperature than alternative monitoring methods. Chemical indicators are temperature labels, which are applied to the product’s container. They are incapable of providing a precise reading, and they are difficult to validate; therefore, they are not considered GxP compliant. An electronic kit-level indicator, on the other hand has to meet the following requirements:

• Must meet GAMP 5 guidelines in its production and development and allow for traceability using a unique ID-number

• Must be low cost, can directly be attached to a kit, and is thin or small enough for use

• Keeps track of statistics, date & time; easily shows the status visually and can document or archive the status in a compliant way

• Allows monitoring without starting the equipment; its battery capacity should be enough to last up to 4 years, and it should have accurate and calibrated temperature sensors

• Must continuously measure temperature and monitor the remaining stability budget

Bringing It All Together

Combining the different data formats from all the sources requires the use of software that has been developed and produced according to GAMP5 guidelines. The software should be user-friendly and provide powerful data plotting capabilities that make analysis easy to perform.

Conclusion

In recent years, the industry has experienced technological improvements, which have made IMPs safer and more effective. The delivery methods are more efficient and economical. These advancements make clinics more open to performing clinical trials, and patients are much more willing to volunteer with the availability of remote monitoring. Choosing the right monitoring solution can be daunting, but ELPRO has a team of experts who are happy to provide you with the knowledge necessary to make your monitoring successful.