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Digital Transformation for Clinical  Trials: Unifying Clinical and Statistical Methodologies

How can clinicians at the forefront of modern clinical trials and statisticians at the forefront of advanced quantitative methods, converge their expertise towards more strategic clinical development? Cytel is channeling the current wave of digital transformation towards mainstream issues in clinical trial strategy, highlighting opportunities to transform linear trial development into synergistic, multi-stakeholder strategy. A recent Cytel webinar explored how digital strategy platforms facilitate such clinical strategy, by ensuring opportunities to explore a vast array of strategic options rapidly and cost-effectively, and evolving workflows for speed and accuracy of insight.

These opportunities arise because the clinical trial industry is quickly learning the value of the holistic approaches made possible through digital transformation. In studies of organizational behavior, the force of digital transformation is largely delivered through the ability of enterprise level technology platforms that streamline various elements of an organization's structure. Organizations like Netflix, Tesla and Glassdoor have used digital transformation to connect R&D with customer insights, diffuse product safety technology remotely, and to generate billions of dollars in revenue from streamlining processes.

In the case of the clinical trial, industry digital transformation enables the unification of statistics with strategy. This means a clinical development journey where uncertainties about safety, treatment effects, and other clinical questions are resolved on the same platform that answers questions about trial design, such as endpoint selection, interim looks, and stratification of target populations. This places clinicians and statisticians into a mutually advantageous dialogue, and results in more optimized clinical strategies.

To demonstrate how such a collaboration might benefit the development of clinical trials, Cytel's Chief Scientific and Medical Officers designed a trial together using a single platform, Solara(R), to resolve both clinical and statistical questions. In doing so they were able to ensure that clinical and statistical considerations informed each other, maximizing the expected gains of each.

See the results for yourself by clicking the button below:

 

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About the Author of Blog: 

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Dr. Esha Senchaudhuri is a research and communications specialist, committed to helping scholars and scientists translate their research findings to public and private sector executives. At Cytel Esha leads content strategy and content production across the company's five business units. She received a doctorate from the London School of Economics in philosophy, and is a former early-career policy fellow of the American Academy of Arts and Sciences. She has taught medical ethics at the Harvard School of Public Health (TH Chan School), and sits on the Steering Committee of the Society for Women in Philosophy's Eastern Division, which is responsible for awarding the Distinguished Woman in Philosophy Award.