Bridging science and humanity: How systems thinking should shape clinical trial execution

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For novel therapeutics, the path to marketing authorization is narrow and treacherous. Among promising drug candidates, fewer than 15% make it all the way from early-phase clinical trials to regulatory approval. This success rate has changed little over the past few decades, even though the costs associated with drug development have skyrocketed.

A study’s success depends on laying the right scientific groundwork as well as differentiating the product. To achieve these things, sponsors need to pay careful attention to three fundamental pillars—scientific integrity, operational feasibility and scalability. Applying a systems thinking approach can create improvements in all of these areas.

Systems thinking involves adopting a holistic perspective and keeping all the factors that influence human...

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