TY - JOUR
T1 - Technology-Enabled Clinical Trials
T2 - Transforming Medical Evidence Generation
AU - Marquis-Gravel, Guillaume
AU - Roe, Matthew T.
AU - Turakhia, Mintu P.
AU - Boden, William
AU - Temple, Robert
AU - Sharma, Abhinav
AU - Hirshberg, Boaz
AU - Slater, Paul
AU - Craft, Noah
AU - Stockbridge, Norman
AU - McDowell, Bryan
AU - Waldstreicher, Joanne
AU - Bourla, Ariel
AU - Bansilal, Sameer
AU - Wong, Jennifer L.
AU - Meunier, Claire
AU - Kassahun, Helina
AU - Coran, Philip
AU - Bataille, Lauren
AU - Patrick-Lake, Bray
AU - Hirsch, Brad
AU - Reites, John
AU - Mehta, Rajesh
AU - Muse, Evan D.
AU - Chandross, Karen J.
AU - Silverstein, Jonathan C.
AU - Silcox, Christina
AU - Overhage, J. Marc
AU - Califf, Robert M.
AU - Peterson, Eric D.
N1 - Publisher Copyright:
© 2019 American Heart Association, Inc.
PY - 2019/10/22
Y1 - 2019/10/22
N2 - 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.
AB - 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.
KW - group processes
KW - randomized controlled trials as topic
KW - technology
UR - http://www.scopus.com/inward/record.url?scp=85073656281&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85073656281&partnerID=8YFLogxK
U2 - 10.1161/CIRCULATIONAHA.119.040798
DO - 10.1161/CIRCULATIONAHA.119.040798
M3 - Article
C2 - 31634011
AN - SCOPUS:85073656281
SN - 0009-7322
VL - 140
SP - 1426
EP - 1436
JO - Circulation
JF - Circulation
IS - 17
ER -