Technology-Enabled Clinical Trials: Transforming Medical Evidence Generation.
Published
Journal Article (Review)
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.
Full Text
Duke Authors
Cited Authors
- Marquis-Gravel, G; Roe, MT; Turakhia, MP; Boden, W; Temple, R; Sharma, A; Hirshberg, B; Slater, P; Craft, N; Stockbridge, N; McDowell, B; Waldstreicher, J; Bourla, A; Bansilal, S; Wong, JL; Meunier, C; Kassahun, H; Coran, P; Bataille, L; Patrick-Lake, B; Hirsch, B; Reites, J; Mehta, R; Muse, ED; Chandross, KJ; Silverstein, JC; Silcox, C; Overhage, JM; Califf, RM; Peterson, ED
Published Date
- October 22, 2019
Published In
Volume / Issue
- 140 / 17
Start / End Page
- 1426 - 1436
PubMed ID
- 31634011
Pubmed Central ID
- 31634011
Electronic International Standard Serial Number (EISSN)
- 1524-4539
Digital Object Identifier (DOI)
- 10.1161/CIRCULATIONAHA.119.040798
Language
- eng
Conference Location
- United States