Technology-Enabled Clinical Trials: Transforming Medical Evidence Generation

Guillaume Marquis-Gravel, Matthew T. Roe, Mintu P. Turakhia, William Boden, Robert Temple, Abhinav Sharma, Boaz Hirshberg, Paul Slater, Noah Craft, Norman Stockbridge, Bryan McDowell, Joanne Waldstreicher, Ariel Bourla, Sameer Bansilal, Jennifer L. Wong, Claire Meunier, Helina Kassahun, Philip Coran, Lauren Bataille, Bray Patrick-LakeBrad Hirsch, John Reites, Rajesh Mehta, Evan D. Muse, Karen J. Chandross, Jonathan C. Silverstein, Christina Silcox, J. Marc Overhage, Robert M. Califf, Eric D. Peterson

Research output: Contribution to journalArticlepeer-review

Abstract

The complexity and costs associated with traditional randomized, controlled trials have increased exponentially over time, and now threaten to stifle the development of new drugs and devices. Nevertheless, the growing use of electronic health records, mobile applications, and wearable devices offers significant promise for transforming clinical trials, making them more pragmatic and efficient. However, many challenges must be overcome before these innovations can be implemented routinely in randomized, controlled trial operations. In October of 2018, a diverse stakeholder group convened in Washington, DC, to examine how electronic health record, mobile, and wearable technologies could be applied to clinical trials. The group specifically examined how these technologies might streamline the execution of clinical trial components, delineated innovative trial designs facilitated by technological developments, identified barriers to implementation, and determined the optimal frameworks needed for regulatory oversight. The group concluded that the application of novel technologies to clinical trials provided enormous potential, yet these changes needed to be iterative and facilitated by continuous learning and pilot studies.

Original languageEnglish (US)
Pages (from-to)1426-1436
Number of pages11
JournalCirculation
Volume140
Issue number17
DOIs
StatePublished - Oct 22 2019
Externally publishedYes

Keywords

  • group processes
  • randomized controlled trials as topic
  • technology

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Physiology (medical)

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