As data decentralizes, however, it raises challenges for knowledge management. Routing data through a “single source of truth” allows teams to access the benefits of decentralized computing without sacrificing the necessity of uniform, standards-based data analysis. Medical affairs and clinical trial teams that embrace a single source of truth model can improve the quality of communication while also reducing the time and effort required to bring a new drug to market.
A single source of truth (SSOT) is a single access point for all knowledge generated by an organization. Knowledge entering the SSOT repository is sorted, formatted, and filed only once, according to uniform rules governing all data in the SSOT.
Stephen Roddewig, a react engineer at Deloitte, compares a single source of truth to the central computer in an all-wheel drive vehicle. This computer communicates with the tire sensors, redistributing power to keep all four tires in contact with the road. At the same time, the computer analyzes information from the tire sensors to inform other tasks, such as reporting engine RPM and miles per gallon fuel metrics.
In this analogy, the single source of truth is the vehicle’s computer. Other parts of the vehicle, including the all-wheel drive system, rely on the computer’s ability to gather information and parse it quickly. Essential metrics of vehicle performance, like engine RPM and fuel efficiency, also depend on information passing through the single source of truth in a standardized way.
The benefits of a single source of truth include:
“Having a single source of truth is essential to provide a seamless customer and employee experience,” write Deloitte’s Eyal Cahana, Dikla Hevion, and Shraavya Koppole. For clinical trial, regulatory, and medical affairs teams, seamless knowledge management and data sharing is essential to successful drug development, regulatory compliance, and communication.
In previous decades, mainframe computing created a default single source of truth. All information passed through a central in-house computer.
Today’s distributed computing supports advances like cloud architecture. Yet it also increases the difficulty of managing and coordinating information among work teams.
“To put it bluntly, sometimes the left hand does not know what the right hand is doing,” writes software developer Bob Reselman. It’s not that teams deliberately attempt to conceal their efforts from one another. Rather, it’s that the lack of a single source of truth hinders their ability to share and coordinate information effectively.
Supporting shared information with a robust digital infrastructure is vital. “Subpar data leads to subpar decisions,” writes Roddewig. Subpar decisions, in turn, hinder team efforts.
Businesses in every industry may concern themselves with removing barriers to team efforts. Such work is particularly important in the clinical trial and medical affairs arena, where difficulties in drug development, patient and provider communications, and regulatory compliance can mean the difference between success and failure in bringing a new medication to market.
For example, an MIT study estimates that only 14 percent of drugs developed in clinical trials ever receive FDA approval. Senior study author Andrew W. Lo emphasizes the importance of efficient and effective data management in shepherding a drug through the FDA approval process — an achievement that depends on effective data analysis in each clinical trial phase. A single source of truth gives clinical trial, regulatory, and medical affairs teams access to reliable data, allowing them to reach reliable insights quickly.
SSOT approaches can also be used to track medications, devices, and other items essential to patient care during a clinical trial.
In a 2021 study, James Tcheng and fellow researchers examined the implementation of a system that assigned a unique device identifier (UDI) to equipment and information sources in a cardiac catheterization and electrophysiology laboratory. The UDI served as the single source of truth — the common data point around which analysis of device use, information gathering, and other tasks were arranged.
The researchers found that while implementation “requires orchestrated re-engineering of clinical and operational workflows,” the result was “a more efficient and effective supply chain.” The researchers also saw reduced documentation errors, more efficient data sharing within the electronic health record system, and even improvements in billing.
A single source of truth allows medical affairs and clinical trial teams to turn their data into actionable insights.
Deloitte’s Ravi Darbha identifies several benefits of a single source of truth approach, including:
Interest in improving communications and knowledge management is currently rising alongside greater interest and commitment to decentralized clinical trials. The direct-to-patient clinical trial model, for example, experienced a boom in growth during the COVID-19 pandemic, although it had been rising in popularity even before the pandemic began, notes Andrea Zobel, senior director of personalized supply chain at World Courier.
In an era of increasing clinical trial decentralization, a single source of truth may be more valuable than ever. Such a source allows for easier harmonization of data and more reliable information. A single source of truth offers a single reliable version of data.
Successful implementation of a SSOT approach for decentralized clinical trials also requires coordination among various in-house and outside partners. These include:
When teams are connected through a single source of truth, they can communicate more effectively, even when each group belongs to a different organization or brings a different perspective to the clinical trial process.
Clinical trial, regulatory, and medical affairs teams can realize the benefits of a SSOT approach by returning to the fundamentals of their knowledge management, communications, and data flows.
“The focus on foundations and starting to use the system early on is key,” says Brian Rizman, partner at cybersecurity and risk management services provider Edgile. The earlier teams familiarize themselves with the SSOT system, the easier it is to adapt to unexpected changes and challenges during the clinical trial process. Using a single source for data and information management reduces the mental workload on teams, who aren’t required to learn new software for each task or topic.
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