The clinical trial process is a critical step in bringing new medications to patients. While it can be lengthy and time-consuming, participating in clinical trials is extremely exciting and rewarding for hospitals and health systems. Providers participate in clinical trials for a variety of reasons, including improving patient care, increasing knowledge and contributing to their field. There are also direct and indirect financial benefits of participation. It is imperative when conducting a clinical trial that regulatory requirements and guidelines are strictly followed.
The National Institute of Health defines clinical trials as “…research studies that explore whether a medical strategy, treatment, or device is safe and effective for humans.” Not surprisingly, healthcare providers who wish to be at the forefront of providing new and effective treatments for their patients welcome the opportunity to participate in trials.
"The importance of clinical trials to the advancement of modern medicine cannot be overstated," according to the article Clinical Trials: How They Work; Why Participate by the Columbia University Medical Center. "Clinical trials partner scientists, patients, and industry in a journey that may improve medical treatments and, in some cases, lead to spectacular medical breakthroughs."
Clinical trials are closely controlled and monitored, with numerous regulations and requirements. Because of the critical nature of clinical trials, and the impacts on patient safety, abiding by the regulatory requirements is imperative.
Clinical Trial Medication Storage and the Advantages of RFID
Clinical trial medications need to be stored securely and may also require specific temperature conditions, such as storage at cold (2° - 8°C) or ambient (20° - 25°C) temperatures. Any security breach or diversion from these storage conditions can impact the effectiveness of the medication and the results of the study.
According to the case study Cold Chain Critical Trials “Clinical trials are important vehicles to validate investigational new drugs. Therefore, national and international regulatory requirements for storage, handling and distribution of investigational products are strictly enforced. Any failure during management of study drug is considered non-compliance and could affect the acceptability of the data generated. In addition, that can result in termination of the study and suspension of all research activities at the site. But, most importantly, noncompliance compromises patients’ safety.”
Providers participating in clinical trials need ongoing visibility to individual drugs and their storage conditions. Intelliguard® Controlled Temperature Cabinets use advanced radio-frequency identification (RFID) technology to provide real-time visibility to drugs in each cabinet, who has accessed, items removed/returned, and any potential temperature excursions. Intelliguard® RFID identifies not only when a cabinet was out of temperature range, but what was in the cabinet – down to the individual item – if/when an excursion happens. This level of granularity provides the confidence and control needed to effectively manage a clinical trial.
The features of the Intelliguard® RFID Controlled Temperature Cabinets that benefit managing clinical trial drugs include:
- Pharmacy-grade cabinets
- Increased security with access control and real-time visibility to user transactions
- Item-level tracking by item and cabinet
- Cold (2° - 8°C) or Controlled Room Temperature (20° - 25°C) storage
- Temperature-excursion alerting
RFID healthcare technology provides the control and visibility needed to manage clinical trial medication inventory with confidence.
Contact us to learn more about RFID innovations for managing clinical trial drug inventory.