Understanding the need for Dynamic Case Management (DCM)
The pharmaceutical industry is systematically inefficient at bringing new drugs to market. Illustrating this point, a recent Tufts Center for the Study of Drug Development research report established that the cost of guiding a prescription drug through the development process to market was approximately $2.6 billion. While this is breathtaking, and the $2.6 billion figure has been hotly debated, of greater concern is the fact that correcting for inflation, the cost to bring a prescription drug to market has increased 145 percent since the last time the study was conducted, in 2003.
Much of the escalating cost is due to increasingly challenging drug products, increasingly complex clinical trials and mounting regulatory complexity. Work-Relay recently completed a dynamic case management (DCM) execution project with a leading contract research organization (CRO) to address these pressure points, and the results were outstanding.
Dynamic Case Management – Clinical Trial Execution is Really a ‘Case’
A case is a scenario, opportunity or challenge with an established outcome that has a definitive open and close, but often with many processes—some predictable, many unpredictable—between open and close. The precise lifespan of a case is typically unknown.
This very accurately describes a clinical trial. A trial formally begins on a specific date and has a very established goal. The goal of a clinical trial is to demonstrate the desired effectiveness of a drug across a representative population sample and to demonstrate side effects or risks that are commensurate with the benefits of the drug. In short, the goal of a clinical trial is to demonstrate drug safety and effectiveness, which are key criteria for regulatory approval of the drug.
While the beginning point of a clinical trial is known and the end goal is clear, there will be many unpredictable decisions that need to be made based on the data flowing back from trial outcomes. Clinical trials are basically impossible to manage with traditional business process management (BPM) technologies due to the unpredictable and ad hoc decision-making that must occur, coupled with complex decision rules governed by regulatory compliance and/or standard operating procedures.
Work-Relay Applied Dynamic Case Management to Transform the Operations of a Leading CRO
Until very recently, a leading CRO used various unconnected applications, large, complex Excel files, and other ad hoc tools to design and track the many processes needed to acquire and execute clinical trials, including the bidding, design, management, and data collection processes. They were using these ad hoc tools because BPM and project management tools on the market did not give them the flexibility and tools they needed to make decisions that could not be predicted or were not sequential in the midst of clinical trial execution.
The challenges were many, including the lack of connection among the company’s many information systems. Therefore, no tool could drive processes across the silos of the various systems to expose what was happening in a specific trial or across the portfolio of hundreds of trials occurring at a given time.
This made it very difficult to efficiently adjust trials as needed and made it extremely difficult to obtain macro-picture views for executive team decision-making. Trial projects often fell behind schedule and, even worse, this CRO often did not understand in a timely way that specific trials were in danger of delay or other negative outcomes.
The CRO happened to be an enterprise SalesForce.com user, so Work-Relay’s process design and management solution worked extremely well in providing a Dynamic Case Management framework. The applied DCM framework allowed this CRO to create an environment for the needed decision-making flexibility, while guiding the clinical trial execution process with integrated data and information, complex rules for guidance at key points and the ability to collaborate cross-functionally and communicate with colleagues.
Dynamic Case Management Reduces Clinical Trials Time and Cost with Overall Operations Greatly Enhanced
Clinical trial execution was becoming increasingly costly and was more frequently falling behind schedule because mid-trial decisions could not be efficiently made and applied to the overall trial an automated way. Even worse, executive management had virtually no visibility into the overall operations to see when resources needed to be reallocated or a specific trial was in danger.
Work-Relay’s DCM capacities were perfectly suited to these challenges. Although previous generations of BPM software solutions were not well-suited for managing variable conditions, Work-Relay thrives within changing conditions consisting of many variables. Powered by the Salesforce platform, Work-Relay’s orchestration engine utilizes libraries of dynamic rules to facilitate many types of decision-making, including automated and ad hoc decision-making for pricing, operational, customer service, and many other purposes.