Clinical trial organizations rely heavily on international standards. Markets across the world accept the use of standards, for example, for labeling symbols and quality assurance processes, as well as many other aspects of operations. Therefore, it is important for the industry to be able to use standards to increase the quality and safety of drugs and at the same time reduce the cost for manufacturing those drugs.
An essential area of standardization is identification, including the use of barcodes. By 2020, serialization, which will make it possible to track and trace each individual package of commercial pharmaceuticals, is expected to cover 80 percent of global drug supply.1 International standards are used for serialization of commercial pharmaceutical products, making it possible to increase the traceability and patient safety of drugs in the most efficient way for the pharmaceutical industry.
The same approach to identification in the clinical trial supply chain has not yet been taken by industry, even though many of the same necessities for having an efficient supply chain exist both in the commercial and clinical supply chain. Realizing the possibilities, a number of innovative clinical trial product suppliers are now starting to collaborate to leverage international standards in clinical supply processes.
Global standards will benefit the Clinical Trial Supply Chain
At any one time, biopharmaceutical companies are sponsoring tens of thousands of ongoing clinical trials, conducted by investigators ranging from the largest research institutions to solitary practitioners.2 With the current trend of more and more treatment changes from mass produced pharmaceuticals to personalized medicines, the number of clinical trials can be expected to increase in the future.
Research pharmacies face the challenge of managing hundreds of trials across multiple pharmaceutical sponsors. Today, each pharmaceutical sponsor identifies and names their investigational products in different ways, each with its own unique packaging and labeling. Products are often serialized and barcoded, but not by a common method compliant with international standards. Because of this lack of standardization, research pharmacies commonly have to re-label packages to manage investigational products, which is an expensive and potentially error prone process.
Clinical trial sponsors are continuously searching for ways to make clinical research processes simpler and more efficient. Implementation of global standards for identification of all investigational products in the clinical supply chain would be a tool to achieve that. A shared method for identification will make it easier and less time consuming for clinical sites to receive and dispense products. Some research pharmacies have as many products being investigated at any one time as equivalent commercial pharmacies, so the benefits can be significant.
Standardizing approaches for identifying investigational products, using global standards can offer many benefits, not only to pharmaceutical manufacturers and clinical sites, but across the clinical supply chain, including technology vendors, customs agents, wholesalers, couriers and contract manufacturers. For example, a trial site only needs ONE process, instead of many, to handle investigational products from multiple manufacturers. Similarly, a manufacturer only needs to generate ONE barcode on an investigational package making it simpler for trial site users. Contrast this with the current process where receiving products into trial sites in the absence of standardized identifiers and barcodes involves manual processes and inefficient double-checking.
Do not reinvent the wheel: Use proven international standards
Rather than create a new standard, clinical trial sponsors are encouraging the adoption of GS1 standards as a common language for the identification of investigational products and for sharing information across the clinical research ecosystem. This will enhance the value of the significant investments to implement GS1 standards for approved drugs that are already being made across the commercial pharmaceutical industry.
The data supported in the GS1 standards, such as lot number, vial number and expiry date, are the pieces of information required to be tracked in clinical trials. Due to the increased requirements for track and trace of commercial products, the level of identification needed is now similar to that required for investigational products. These similarities form an even stronger case for clinical trial sponsors to leverage the learnings of commercial pharmaceutical processes and to implement global standards in a similar way, while of course respecting clinical trial specificities.
It is important to remember: GS1 barcodes are used to make sure that the right medicinal product is administered to the right patient at the right time, via the right route and in the right dose. This is a fundamental patient expectation and obligation of the nurses and doctors caring for them – irrespective of whether that product is distributed via a commercial supply chain or as a product subject to a clinical trial.
It is recognized that clinical trials processes have complexities not seen elsewhere
When considering application of GS1 standards, there is clear recognition that clinical trials have identification complexities not seen today in the commercial health care supply chain. The uniqueness of an investigational product, which in many cases is only for a single patient, means that this must be identified to the instance of the product. In blinded trials the investigational product, comparator or placebo, must not be differentiated from each other when GS1 standards are applied.
An industry working group, conducted through the GS1 Global Standards Management Process, are developing a best practice guideline for application of GS1 standards for identification and barcoding of clinical trial products, locations, patients and caregivers, ensuring that the business and process requirements of all stakeholders are considered. All industry stakeholders interested in this topic are encouraged to get involved.
Reuse experiences and processes where possible
It does not make sense to use different approaches to identification and barcoding. It should not matter if it is a clinical or a commercial product. They should be identified in the same way and not treated differently just because they are part of two different supply chains. Our request to all industry stakeholders is to collaborate to implement global standards for unique identification and barcoding across clinical supply processes. This effort will help to ensure the quality of care and patient safety.