Today's Mission Critical: Making Sense of Spending on Clinical Trials - Pharmaceutical Executive


Today's Mission Critical: Making Sense of Spending on Clinical Trials

Pharmaceutical Executive

Looney: Data is often seen as the solution to efficiency deficits and escalating costs. Is more and better data a prerequisite for accurate planning—if so, where are the gaps? Has technology kept pace with the move toward fully integrated operations?

Getz: Industry collects enormous amounts of data, but much of it is useless. The truth is you cannot manage what you are not measuring correctly. What industry needs is to be much better at articulating a standard set of quality-based metrics—metrics that provide insights. The Metrics Champion Consortium is one such effort underway to do that.

Popovici: There is a challenge in the understanding across industry about financial metrics that we can use to track performance in the trials space. We are very good at data built around development cycle times and enrollments and site monitoring. In those cases there is a baseline understanding on definitions and terminology on which to measure. On the budgeting side, there is less consensus on how comparable metrics would be across companies or what you are measuring against.

Guzman: We are working toward defining a standard for baseline that can be used to evaluate variances in a trial budget.

Treiber: I wonder whether any such metric is possible. These trials span different therapeutic areas. They are global, with multiple sites; the metric in Norway just can't be the same as in the United States. Our efforts are focused on developing only a few and to apply them only to the present tense.

Grygiel: Information is abundant and the tools to make sense of it are there. Our challenge as a vendor is finding the right people in the organization who know what they want and are committed to overcoming the preferences that colleagues may have just because it's comfortable for them. What we look for is good organizational alignment as the starting point for creating systems that provide better metrics.

Popovici: For Takeda, the issue is not only the standardization of metrics. It's also finding processes that allow for flexibility and integration in how all the data can be used and analyzed. We want to be able to tie our systems to something that can be measured consistently and help create future process improvements. There is a need for tools that talk to each other across the functions; both operational and financial.

Grygiel: We must acknowledge that we are at the aspirational stage in the application of data to build consistency in trial budgeting. There is potential in all directions. ClearTrial launched in 2007 with a customer base in clinical operations. Then we found that outsourcing was interested in working with us, followed by finance and now resource management. It raises a useful but unsettling question: who is our customer?

Looney: To conclude, what changes or improvements do you see in the trial budgeting process moving forward, over the next three years?

Grygiel: There will be a marked shift toward more outsourcing. This means that companies have to collaborate more with the organizations they outsource to. Better joint planning, beyond simply sharing spreadsheets. Another change is the need for more understanding of the difference between what was planned in the budget and what actually happened. This information has to be evaluated in real time and sent back into the planning process so that it can serve as a source of meaningful advice. It's the starting point for acceptable metrics. Third is being able to incorporate learnings from throughout the industry and using these to shape your own budget planning.

Getz: Patients are going to be more involved in the crucial area of protocol design. They could play a huge role in helping us understand what makes a protocol feasible and executable. Building in that patient perspective can help improve the accuracy of budgets too as patients help ground a study in terms of what can reasonably be performed during the life of the protocol.

Treiber: Collaboration is the strand that runs through everything we discussed today.

It is a theme much larger than budgeting more efficiently, but the end result is the same. Consider all the efforts underway to build a collaborative platform around biomarkers, which allows for better targeting of patients who could benefit from a therapy. It will help reduce our patient trial numbers as well, with an even bigger impact on our costs. Patient groups like the Myelin Repair Foundation are funding researchers that collaborate in MS research. The industry just has to reach out—and be prepared to accept the "out-of-the-box" idea that on close examination carries great merit. Another area where more focus is required is the investigator grant—two thirds of the average trial bill comes from indirect sources; a lot of this is investigators charging us disparate amounts for their work.

Popovici: Collaboration is also going to be more global. Our trial work will need to be sensitive to the requirements of not only the FDA and the EMA but of the many emerging markets as well. Trying to accommodate their different regulatory demands and expectations will induce some conflict. It will test our functional capabilities and ability to be flexible. Hopefully, we can improve on becoming more aware of the diverse requirements and build a more efficient global development program rather than regional ones.


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