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Abstract:
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It has been recognized that traditional clinical trials often fail to recruit study participants that adequately reflect the population that most likely benefit from the medicine once it is approved. Accordingly, there has been a growing interest in enhancing the diversity of clinical trial populations through use of novel approaches pertaining to study design, enrollment practices and data acquisition. We consider the role of emerging technologies in addressing some of the difficulties, with special reference to the promise of the so-called virtual or digital trials and the associated operational and ethical challenges. The potential application of modern analytic tools is highlighted, using examples from other industries where these techniques have proven to be transformative and exceedingly effective in dealing with analogous situations.
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