Protecting Your Protocol: Operating a Flawless Clinical Agent Repository

Posted by John A. Kudrick on Mar 25, 2014 10:30:00 AM

Protecting Your Protocol eBookManaging the distribution of clinical agents for large, multi-site, multi-country clinical trials requires a spectrum of expertise and infrastructure, specifically designed to ensure accuracy in order processing and preservation of the integrity of the product from initial receipt into inventory through delivery to the clinical site. 

These processes are well established for small molecule and other traditional agents. However, the number of cell-based and biologically derived therapies entering clinical trials is increasing exponentially, and includes monoclonal antibodies and other injectable biologics, agents derived from blood products, and cell- and genetically-based therapies, as well as new vaccines and diagnostics. Most of these must be stored and transported within certain temperature ranges—refrigerated or frozen—and may require near-absolute compliance with a specific temperature requirement, such as between -79°C and -86°C. For this reason, managing and distributing biologics for clinical trials involves additional layers of complexity to meet regulatory requirements and collect and manage the associated data.

Repositories that manage agents for clinical trials must operate at a level of accuracy that approaches “flawless.” In addition to storage capacity at a range of temperatures, proven processes for handling and management of these specialized products, a robust quality system and a well trained and experienced staff. If you have such products entering clinical trials, how will you manage distribution to your study sites? Should you outsource or invest capital in infrastructure and staffing? Here are a few insights.

temperature monitoring biologics

Pharmacists and facilities that support clinical trials operate very differently than retail pharmacies. A pharmacist in a retail drugstore is concerned that patients are dispensed the correct medication, correct strength, and in the correct quantity. Repositories that support clinical trials, however, are not only focused on the patients receiving the medications, but also the study protocols. This focus on the protocol, especially in supporting blinded clinical trials, necessitates a far greater level of inventory control on a daily basis.

FDA approval for preventing medication errorsThe danger of a mistake in dispensing medications does not need to be explained. The consequences of an error in dispensing to a single patient are readily understood, but a mistake in managing inventory that supports a clinical trial can harm both the patient and the protocol, and also endanger the outcome of the entire clinical trial. Agents are frequently supplied at no cost, and an error that results in unreliable data or compromises the results can cause the manufacturer to pull out of the trial and the protocol canceled. This may result in a therapy that may have otherwise shown great promise not continue down the pathway towards FDA approval.

Errors in dispensing medication in retail and hospital settings come from many directions and include such factors as similar drug names, poor label design, small print, crowded shelves, and distracting environments. Much has been done to help prevent errors in dispensing medication in retail and hospital pharmacies. These include efforts by manufacturers to make the print on labels clear and easy to read, use of color and innovative design to distinguish products with similar names, and prominent display of critical information such as the strength.

However, packaging that helps prevent errors in retail situations is generally not an option for organizations supporting clinical trials. This is either because of cost (in the case of open-label trials) or because variations in packaging must be completely eliminated (in the case of a blinded trial) to prevent distinguishing between the active agent and its placebo.

In the absence of distinguishing labels and packaging to help differentiate clinical agents, repositories must rely on proven processes and well-trained, experienced people to achieve the level of accuracy needed to successfully support clinical trials.

preventing medication errors on labels

Operations that support clinical trials need to not only take extensive measures to ensure accuracy in their operations, but also to consider what happens after the agents are safely delivered to the clinical sites. The primary focus of a clinical agent repository is the integrity of the protocol, and an excellent provider understands what happens at the clinical site and will work to minimize risk all the way to the patient. This is a value-added service and should not be minimized: the dispensing organization has an opportunity to spot disasters waiting to happen and should alert the client.

What are some of your challenges with minimizing risk all the way through to the patient beside from your drug manufacturing or distribution site? Please comment below and share with us your experiences.   

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