How to Juggle Clinical Development

Recently I found myself locked in a room full of four-year olds. After running out of Goldfish snacks I decided to entertain them by juggling. They were mesmerized – but just for a moment; to keep their attention I asked three of them to help by throwing me the balls to start with. After a few attempts, I caught all three balls and my little fans cheered. However, it wasn’t long before someone threw a fourth ball to me – which I dropped – then a fifth ball, then a block, then a doll… You get the picture.

Months later, I was speaking to a clinical operations executive who remarked about how they had so many ‘balls in the air’. I couldn’t help but reflect on my own juggling experience and realized that successful clinical development today requires the artful juggling of myriad activities – increased number and length of trials, more patients enrolled, greater number of procedures performed, increasing volume of data collected, more geographically dispersed sites, more extensive outsourcing relationships – the list goes on and on. How do clinical development professionals keep all these ‘balls’ in the air? How long can these activities be juggled successfully?

Clinical executives have three options to address these challenges:

• People: either internal or external headcount (outsourcing).
• Process: a combination of SOPs, meetings, approvals and other steps.
• Technology: electronic tools that can productively accomplish the same end results.

Although capable people are absolutely necessary, the old adage ‘too much of a good thing’ certainly applies. Just think of a small stage crowded with jugglers – eventually they start to get in the way of each other. Financially, most companies are looking to cut costs significantly and many have mandatory headcount constraints. Continued investment in ever-greater numbers of people is not a practical long-term solution to the pressures the industry faces.

Generally, for well-run organizations, process change yields incremental benefits. In economic terms, process changes have diminishing marginal returns, meaning that each subsequent change has less of an impact than previous changes. Even high-profile approaches such as six-sigma, particularly when applied piecemeal, do not produce transformative results. When was the last time a new committee was heralded as the reason the organization became more productive?

The only way to meaningfully affect the time/cost equation in clinical operations is through technology – but technology is not a panacea. Ask executives in charge of actually executing studies and most new technology, at least initially, is akin to juggling more and more balls – maybe even flaming sticks or chainsaws.

Too frequently, the ultimate objective of drug development gets lost in the rush to implement a technology solution. The aim is not to have visit data available earlier or to reduce the time to data lock or any other intermediate goal. What is really important is to cost-effectively and efficiently produce more robust clinical results that allow development decisions to be made with confidence.

Truly useful technologies directly inform decision-making processes in a way that changes the types of activities that are actually being conducted. In a March 2006 report entitled “Has EDC Jumped the Shark?”, Chris Connor, Senior Research Analyst at IDC Healthy Industry Insights, wrote: “If you ascribe to the premise that ‘garbage-in equals garbage-out’, then EDC solves a basic set of problems.” Technology investments, therefore, should focus on the earliest root causes of cost and inefficiency.

As EDC adoption accelerates, the ambiguities of the protocol development process become much more apparent. Becky Kush, CDISC President, states that: “The protocol is at the heart of every clinical trial. It is the plan; it is a critical document for everyone involved in the conduct of the trial.” Yet in numerous companies, after physicians determine the scientific basis for the study, many of the key operational details are left to a host of others to sort out – that’s like starting to juggle and then telling someone else to take over: it’s difficult but can be done.

Technology exists today to dramatically inform the study design process by:

• Capturing protocol content as data for re-use by downstream activities including EDC/CTMS systems, trial registries, protocol warehouses, etc.
• Comparing proposed study designs to industry cost and procedure benchmarks.
• Querying the study plan itself to identify and correct inconsistencies/deviations.

Implementations at several companies have found that applying this technology at the earliest stages of protocol development reduces the time and cost associated with study initiation and execution activities. Importantly, study teams are better able to focus on the relevant scientific questions because the technology identifies the operational discrepancies that inevitably occur throughout the complicated process of designing the overall study plan.

So when it comes to clinical development, how long can pharma continue to juggle so many crucial activities? World record-holder Bruce Sarafian once juggled 12 balls – but he only made 12 catches. The moral is even though an organization might be able to handle a lot, at some point the burden will become too much and the balls come crashing down. Prudent investments in technology can change that equation.