Peter Sturtevant

	Pharmaceutical companies sponsor tens of thousands of ongoing clinical research studies at any one time, testing the safety and efficacy of investigational products with researchers ranging from the largest institutions to individual practitioners. The mapping of the human genome and the advent of personalized medicine has expanded the possibilities and the complexity of clinical trials to a point where clinical researchers are now seeking effective treatment for millions of unique patients, in addition to targeting specific diseases.

	The search for individualized treatments leads to increasing research studies and investigational drugs. Currently, the multitude of investigational products being researched at any one time are all identified and named differently by each pharmaceutical sponsor. They are typically serialized and barcoded, but without a common method. Research pharmacies like the one at the Dana-Farber Cancer Institute (Dana-Farber) face the challenge of managing hundreds of studies with multiple pharmaceutical sponsors, each with its own unique packaging and labeling system. This product identification disparity creates unnecessary inefficiencies downstream at research labs and facilities, where multiple formats and methodologies have to be translated and manually entered for internal inventory tracking.

	In an industry where supply-chain integrity plays an important role in protecting patient safety, consistency is crucial. “There are about 750 active drug studies at Dana-Farber. In the research pharmacy, without a common standard, the pharmaceutical sponsors are each doing things differently, posing significant challenges as well as potential medication safety issues," says Caroline Harvey, research pharmacy manager for Dana-Farber.

	Four leading pharmaceutical companies-Amgen, Eli Lilly and Company (Eli Lilly), MSD and Pfizer-are speaking out to advocate for the use of standardized barcodes for investigational products. Along with 

®, a collaborative industry group that seeks to solve supply chain and business process challenges through the adoption of GS1 Standards, they believe standardization will enable more efficient processes at institutions that are already using an electronic inventory system to manage investigational products.

	"While all of us (pharmaceutical sponsors) identify our investigational products in a unique and traceable manner, the absence of standardization makes it harder and more time-consuming for clinical sites to receive and dispense products," says Jodi Smith-Gick, senior advisor of product delivery and supply at Eli Lilly.

	Rather than create a new standard from scratch, Amgen, Eli Lilly, MSD and Pfizer are encouraging the adoption of global GS1 Standards for the identification of investigational products as well as information sharing throughout the clinical research ecosystem. Such a shift would build upon significant investments already being made across the pharmaceutical industry to implement GS1 Standards for approved medications.

Research and opportunity                                 

	Advances in science and technology-from genomics to Big Data-are driving the evolution of a new generation of medications. "The unraveling of the human genome and the discovery of a myriad of molecular targets has led to the concept of personalized medicine," says Harvey. Ultimately, this shift will lead to the development of more effective treatments and cures, but it also poses challenges to the already strained clinical research ecosystem.

	Such rapid expansion of research opportunity demands more efficient management of drug protocols in an increasingly complex supply chain. Dana-Farber, along with Amgen, MSD, Eli Lilly and Pfizer, explored various methods of simplifying and streamlining clinical research processes. The sponsors’ commercial businesses, all of which are retooling manufacturing operations for existing medications for serialization in compliance with the 2013 Drug Supply Chain Security Act (DSCSA), were quick to recognize that the implementation of GS1 Standards in research could help achieve consistency in investigational product identification and, at the same time, provide a foundation for innovation. However, pharmaceutical companies have yet to embrace standardization for the investigational products destined for clinical trials.

Integrating consistency throughout the ecosystem

	When a research pharmacist or clinical research coordinator receives an investigational product from a pharmaceutical sponsor, they become responsible for the "chain of custody" from the product’s arrival at the research facility until it is dispensed to patients-requiring them to maintain its pedigree.

	Many different players in this expanded clinical supply chain, such as technology vendors, customs agents, couriers, and contract manufacturers, handle investigational products along the way, compounding the complexity of unstandardized identification methods among research facilities and pharmaceutical sponsors.

	A variety of new digital technologies including mobile apps, electronic health records, Internet of Things (loT) sensors, and more, are rapidly being introduced to clinical trials, improving efficiencies and enabling collection of clinical data in new and novel ways. For instance, smartphones could be used to provide patients with crucial product information such as recommended dosing regimens and dietary restrictions in their own homes. GS1 Standards can provide an interoperable foundation across multiple data platforms.

	"If pharmaceutical manufacturers align on a standard, this will allow vendors to develop integrated technologies," adds Smith-Gick.

	While many research sites are still using paper tracking processes for investigational products, the use of electronic inventories is gaining traction. When an investigational product is received into the electronic inventory system at Dana-Farber, a unique, internally-generated barcode is created and affixed to each dispensable unit, while information from the shipping documentation must be entered into the system manually.

	Pharmaceutical sponsors recognize the challenges faced by these sites. "Normally a site that conducts clinical trials works with multiple companies and runs multiple studies. If they're running studies from ten companies, the research pharmacy may need to use ten different scanners," says Kristen May, director of clinical supply chain at Amgen.

	The numbers also add up on the pharmaceutical side. Large pharmaceutical companies commonly support hundreds of research studies in more than 70 countries, impacting tens of thousands of research sites and hundreds of thousands of patients. A single, late-phase study can involve as many as 1,000 investigators. By employing standardized identification procedures in clinical research processes, pharmaceutical companies could automate manual processes to gain greater efficiency.

	“With standardization, we wouldn't have transcription errors that we typically see on the back end, nor would we need to spend as much time verifying and validating data," says Jeff England, director of global clinical supply for MSD.

	Most pharmaceutical companies are already using a common digital language based on GS1 Standards for identifying commercial products. Throughout the industry, GS1 Standards have been adopted to increase patient safety, supply chain security and efficiency, traceability, and accurate data synchronization in the commercial supply chain.

	Pfizer’s Hans von Steiger, Director/Team Leader, and his peers argue that the time has come for the same standards to be adopted in clinical research. “A common pharma format for barcodes makes sense – there is no need to create a new format when a GS1 Standard is already available. The industry can and should move towards using GS1 Standards throughout,”

	And since compliance with the DSCSA is already well underway industry-wide, now is an ideal time to add clinical research investigational products to the standardization effort.

Applying GS1 Standards in clinical research

	For commercial drugs, a GS1 Global Trade Item Number® (GTIN®) is used to identify and provide information about various products. This GTIN includes the GS1 Company Prefix, which identifies the manufacturer, and the Item Reference, which uniquely identifies the product from the consumer’s perspective. When a serial number is added to the GTIN, it identifies the specific package that will be dispensed to the patient. The GTIN and serial number are encoded in a barcode that is applied to the product's packaging.

	By moving away from proprietary and disparate product identification systems to embrace the common language of GS1 Standards, clinical research teams and other supply-chain members could easily identify a specific container of an investigational product and access information about it by reading the container's barcode via a simple scan.

	Additionally, GS1 Standards provide the needed flexibility to "start small" and gradually extend their use to other parts of a process. Pharmaceutical sponsors could begin with a simple GTIN and serial number encoded in a 2-dimensional GS1 DataMatrix barcode, and build upon this over time.

	The pharmaceutical industry, whether directly or through third-party providers, is investing in infrastructure to facilitate the kind of information sharing required by the DSCSA. This infrastructure could be leveraged in the future for sharing information about investigational products, as well.

	Von Steiger asserts that the extensibility of GS1 Standards offers an additional benefit. Each new application of standards gives rise to additional ways of gaining operational efficiencies. For example, various methods of electronically exchanging information, such as the GS1 Electronic Product Code Information Services (EPCIS) for pharmaceutical products, is fundamental to meeting the interoperable requirements of DSCSA by 2023. In practice, most Advance Shipment Notification (ASN) EDI transmissions include GS1 Standards like the Global Trade Item Number (GTIN) and Serial Shipping Container Code (SSCC) to uniquely identify each product in a pending shipment, helping recipients to plan for its arrival and to validate its contents once received. When EPCIS events (containing GTINs, Global Location Numbers (GLNs) and SSCCs) are recorded and shared among supply chain trading partners, the product’s location and chain of ownership will be visible to all trading partners.

	At community hospitals and private office practices that serve as research sites, the advantages of using GS1 Standards-specifically accuracy, efficiency, process familiarity and safety-deliver benefits that extend throughout the medical community, including to the patients themselves.

	"If we harmonize our operations on standards, we are not just benefiting the drug industry or the research community, but all the doctors, hospitals and other healthcare facilities that scan barcodes," May says. "It doesn't make sense to use different codes. It shouldn't matter if it’s a clinical product or a commercial product. They should be able to follow the same identification approach."

	England adds, "We're driving toward a consistent enterprise model across clinical and commercial supply to ensure the highest level of control and efficiency in the management of our products. Investigational drugs shouldn't be treated differently than commercial drugs, just because they're part of a clinical trial."

	"Pfizer is committed to using GS1 Standards for clinical research," Von Steiger says. "We are encouraging others in the industry to make the same commitment for the common good."

	Amgen's May strongly agrees: "The logistics of product management are not where we should be competing. We should be competing on the basis of science.”

	"It’s important that we (pharmaceutical sponsors) adopt one set of standards across the industry-one barcoding practice, one labeling approach-so that clinical research sites can benefit from more efficient processes," says Smith-Gick.

	Amgen, Eli Lilly, MSD and Pfizer suggest that their peers work with their organizational teams responsible for implementing GS1 Standards on the commercial side to learn how to leverage and build synergies on the clinical side. Pharmaceutical sponsors will need to take steps to implement the changes in packaging and ERP systems to create and manage GTINs, and possibly convert to 2-dimensional GS1 DataMatrix barcodes.

	"It’s important for the industry to make the commitment and get started transitioning to GS1 Standards. Then, we can work together to leverage the information-sharing power enabled by these standards," explains Von Steiger. "It's time to lay the foundation today to support clinical research and tomorrow's breakthrough cures."

	For more information on GS1 Standards in healthcare, visit  

, Senior Director of Industry Engagement, Pharmaceuticals, GS1 US

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The GS1 Standards will enable more efficient processes at institutions that are already using an electronic inventory system to manage investigational products.

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