Trial by Design - Pharmaceutical Executive

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Trial by Design
By incorporating an operations perspective, companies can design trials that they can actually execute.


Successful Clinical Trials Management


Shifting R&D to a more balanced focus on both scientific and execution quality will not be easy. Despite the rising costs and increasing timeframes of clinical trials, most R&D organizations seem unable to implement any fundamental, systematic improvements to protocol development and execution. Rather, they continue to make changes at the margins, where resistance to change—and positive impact on the bottom line—are minimal.

Management should expect serious resistance to these efforts. Every argument from "the tools aren't useful in my situation" to "my trial is particularly difficult and therefore shouldn't be measured" or "the schedule and budget were mandated by others" will be put up in defense of poor performance. But by remaining steadfast, management will convey their resolve, and, eventually, the performance measures will start to show improvement.

Taking aggressive steps to create ownership within the R&D organization of both scientific- and execution- protocol quality will yield significant increases in R&D value, from decreased costs per trial and increased staff efficiency to increased speed to market and increased portfolio integrity and flexibility.

David S. Zuckerman is president of Customized Improvement Strategies. He can be reached at
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