Staple Yourself to a CRF

Don't search this column too hard for discussions on spiffy new technologies--you won't find any. Yet, practically every concept in the column relates to the application of technology.

As I have emphasized in past columns, technology doesn't solve problems; process change does. Technology is the grand enabler of process change. We are witnessing this today, as the pharmaceutical industry undergoes a transition from manual processes to automated, technology-enabled processes for the development of protocols, IRB approvals, document distribution, clinical data management, and many other aspects of clinical development. This revolution in clinical development follows directly from the revolution in traditional businesses over the past several decades.

The relationship between process change and technology was initially, and most clearly, made in the late '80s/early '90s as business focused attention on the supply chain. This focus led to the rise of customer relationship management (CRM) software. CRM systems automate virtually all of the processes that "touch" a customer--from marketing and competitive intelligence, to sales and customer contact, through service and help desk management. CRM systems can literally run a business and provide access to deep understanding and benchmarking of the process through the use of business intelligence tools.

As mentioned, CRM software grew out of an extended, in-depth examination of the entire process of customer management. A seminal article that examines this, written by three Harvard Business School professors in the Harvard Business Review (HBR) in 1992,¹ was called "Staple Yourself to an Order." If you haven't read it, download a copy from the HBR Web site.² The article discussed the concept of an order management cycle (OMC)--the process by which an order is considered, placed, and fulfilled within a company.

Their argument was that OMC inefficiency was responsible for much customer dissatisfaction, interdepartmental internal strife, and financial inefficiency in business. They suggested that senior managers in organizations should realize that an order is, in fact, a surrogate for the customer. In their words, "every time an order is handled, the customer is handled. Every time the order sits unattended, the customer sits unattended."

By "stapling themselves to an order" managers could begin to understand the arcane, multidepartmental, and complex process that each order (customer) travels in being fulfilled. By doing this, they will literally see their company from the inside-out--and will understand how and why the process needs to change.

The compelling concept expounded by these professors is applicable to any business process, and the lessons learned apply very directly to the process that interests us--clinical trial data collection and management. So, let's look at some of the lessons they learned and think about how they apply to clinical trials and your organization.

The idea of customer may seem foreign in this setting, but I think it is only a very small stretch to consider the investigator and the staff at a clinical trial site as "customers" in this process. The investigative site is involved to some extent in developing a protocol and CRF, and in entering the data, but rarely is privy to the internal data management process until site workers are asked to address a query or sign a CRF. They often experience frustrating delays and painful processes, imposed by the sponsor, in recording and modifying data.

Like the customer in the OMC, the investigative staff is often frustrated by the process. And, like the customer, the good investigator is a very precious resource--their happiness can mean the difference between a successful study and a failed one. That being said, do we ever really examine the process of data management from their perspective, by "stapling ourselves to a CRF"?

Many of the examples relate to the paper-based CRF process still used in the large majority of clinical trials. But even when an electronic technology is directly imposed onto this process, many of these considerations still directly hold.

The OMC and the Data Management Cycle (DMC)
The OMC, as defined by Ben Shapiro and colleagues, moves through 10 discreet steps, starting with order planning and moving through processes such as order generation, cost estimation, order entry, scheduling, fulfillment, and billing. Many steps required the crossfunctional involvement of a variety of departments: sales, marketing, service, operations, and finance, with supporting roles from many other departments. Again, in their words, "The OMC is everybody's job, but overlapping responsibilities--and lack of management involvement--often lead to confusion, delays, and customer complaints."

By stapling themselves to orders at 18 companies, they identified four overall problems with the OMC in most companies. We shall examine each in turn, along with some related lessons for the DMC.

Whole of parts or parts of whole
The people involved in the processes of the OMC don't view it as a whole system. They are typically involved in a particular vertical aspect of it--for example, sales or order entry, and understand their process well. But they seldom know the details of the other parts of the process; it is a "black box" to them. Furthermore, they assume that somebody upstairs in senior management understands the system as a whole, which is not necessarily true. Those managers above the vertical functional areas are too distant from the details to understand the inefficiencies and problems in the process. In fact, senior managers frequently simplify or inaccurately describe the process when asked.

Unfortunately, this may ring true for many clinical development organizations, despite years of attention, process optimization, and best practices. Often, protocols are developed without consultation with data managers as to how the data are to be collected, and data collection forms are developed without sufficient discussion with statisticians as to how the data are to be analyzed. CRF developers may not consult with CRAs to see how the data will be collected at sites, and often the site's workload isn't considered in piling up procedures for a single visit. In the planning process, people are focusing on their vertical organization and not on overall process.

The process of data collection and data management is also often designed to sequentially serve the individual groups while keeping data in silos, where it cannot be accessed by those who need it. Each functional area waits in line for their role in examining the CRF or data.

Falling through the cracks
The study of 18 companies found that the movement of orders between vertical silos was frequent, and often poorly managed. Many different departments were involved in each step, and no step was the sole responsibility of any department. Although primary responsibility for each step was assigned, the overlapping involvement often led to small and large disasters. Orders literally dropped through the cracks as they were handed from step to step. Even worse, the different groups had different political agendas in the process. Aside from finger-pointing, there was frequently contention and internal game playing in the planning and execution of the OMC. Each department has different goals, different compensation schemes, and organizational mandates.

Communications and data fall through the cracks in clinical development organizations in much the same way. One common example is the cross-communication of information between clinical data management and drug safety departments. It is all too common for critical data quality or patient safety information to fail to be communicated between these groups because of the silo nature of the two groups in most companies and the lack of completely interoperable systems and processes.

Invisible at the top, incommunicado at the bottom
Top management, whether assigned to a particular department or not, was too distant from the OMC process to understand it, or to follow its progress. Inefficiencies and pain points weren't necessarily communicated, and if they were, it was typically in the setting of a disaster. The customer service representatives had daily contact with customers and saw the problems and frustrations. Yet, because of their position in the organization, customer reps often had little ability to communicate this information upwards.

In the clinical trial process it is the CRA and the data manager who interact with the customer and the process on a regular basis. They see the inefficiencies and experience the frustration. They are the ones who can predict a problem months before it happens. Yet, unless senior management has studied the process and developed methods for communicating such feedback, their messages often go unheard where and when they could make a difference.

Stuck in the middle
The customer is involved in negotiating and placing the order, receiving the goods, and possibly in returns or service calls. However, the rest of the process is typically invisible to them, but can be the cause of delays, errors, inefficiencies, and huge frustrations.

In this regard, the investigator and staff is very much like the customer. Once they complete the CRF and it is monitored, they have no idea that there may be dozens of steps before it is considered clean and ready for analysis. All they see are the seemingly random stream of queries and data clarifications coming back--some within a month or two and others six or 12 months later. They occasionally get a call, sometimes from their CRA, sometimes a medical monitor, and sometimes even a data manager. Although this affects them, often negatively, they have no further insight into what is happening.

Where's the stapler?
Once we realize that the OMC principle applies directly to the DMC, how do we go about fixing it? First, top managers in the organization need to travel horizontally through the entire process and intimately understand the DMC, and how it affects the investigator and the internal staff. They need to visually draw the DMC in great detail and chart all the gaps. This is not the same as indicating all the connections. Rather, they need to trace the linear and branching paths taken by a CRF as it travels the process. Next, consider the trial from the investigator's perspective, which places investigator satisfaction as a goal.

The next step in fixing the DMC is to bring together the pieces of the cycle into a whole, typically through crossfunctional and interdepartmental projects, charged with measurable business goals relating to timing, cost, and efficiency. This is hampered in many clinical development organizations where costs aren't typically well understood.

This is the step where technology plays a crucial role (you KNEW I was going to get back to technology, didn't you?). We have reached the point where integrated data collection, management, trial management, and safety systems can work along with document management, training, and other electronic systems to integrate many steps of the DMC. In addition to improving flow and visibility, the use of electronic systems provides the opportunity for understanding the process through the use of business intelligence tools. For the first time, it is possible to measure time to query, time to answer, and time to look for an individual data item or CRF. People can be individually managed in comparison to others. The process can be designed and managed to greater efficiency through the use of technology.

The original HBR paper discusses this at the dawn of the modern computer age, suggesting that "Direct computer links with customers [or, for the DMC--investigative sites] and integrated internal computer systems...typically results in lower costs and better analysis." Interestingly, they also foreshadow the current eSource debate in our world with the comment that "data [can] be captured at the source to avoid repeat entry and inevitable clerical errors."

Finally, the authors conclude that "it is critical to recognize that the OMC [and by extension, the DMC] is at the center of all political maneuverings in the company." Management needs to descend from the executive suite to the lower levels of the organization and set up opportunities to listen to and get ideas from the very people who are touching the customer each day.

Conclusion
What can we expect from a fixed OMC and DMC? The first benefit is improved customer satisfaction--which in the case of the DMC means better investigator performance and interest in repeat participation. A second benefit is reduction in interdepartmental strife, which would be welcome in many companies. Finally, from an improved OMC companies can expect better financial performance. For the DMC in clinical trials I would look for the possibility of achieving improvements in all three vertices of the business triangle--cost, quality, and timeliness--with better attention to patient data and patient safety.

References
1. B.P. Shapiro, V.K. Rangan, J.J. Sviokla, "Staple Yourself to an Order," Harvard Business Review, 113-121 (July-August 1992).
2. http://harvardbusinessonline.hbsp.harvard.edu/b01/en/common/item_detail.jhtml?id=R0407N.