Technology-Enabled Clinical Trials Transforming Medical Evidence Generation

被引：52

作者：

Marquis-Gravel, Guillaume ^{[1
]}

Roe, Matthew T. ^{[1
]}

Turakhia, Mintu P. ^{[2
,5
]}

Boden, William ^{[6
,7
]}

Temple, Robert ^{[8
]}

Sharma, Abhinav ^{[3
,10
]}

Hirshberg, Boaz

Slater, Paul ^{[9
]}

Craft, Noah ^{[11
]}

Stockbridge, Norman ^{[8
]}

McDowell, Bryan ^{[12
]}

Waldstreicher, Joanne ^{[13
]}

Bourla, Ariel ^{[14
]}

Bansilal, Sameer ^{[15
]}

Wong, Jennifer L. ^{[16
]}

Meunier, Claire ^{[17
]}

Kassahun, Helina ^{[18
]}

Coran, Philip ^{[19
]}

Bataille, Lauren ^{[20
]}

Patrick-Lake, Bray ^{[1
]}

Hirsch, Brad

Reites, John ^{[21
]}

Mehta, Rajesh ^{[22
]}

Muse, Evan D. ^{[23
,24
]}

Chandross, Karen J. ^{[25
]}

Silverstein, Jonathan C. ^{[26
]}

Silcox, Christina ^{[27
]}

Overhage, J. Marc ^{[28
]}

Califf, Robert M. ^{[4
,29
,30
]}

Peterson, Eric D. ^{[1
]}

机构：

[1] Duke Clin Res Inst, POB 17969, Durham, NC 27715 USA

[2] Stanford Univ, Ctr Digital Hlth, Stanford, CA 94305 USA

[3] Stanford Univ, Div Cardiol, Stanford, CA 94305 USA

[4] Stanford Univ, Dept Med, Stanford, CA 94305 USA

[5] VA Palo Alto Hlth Care Syst, Palo Alto, CA USA

[6] Boston Univ, Boston, MA 02215 USA

[7] VA New England Hlth Care Syst, Bedford, MA USA

[8] US FDA, Silver Spring, MD USA

[9] Microsoft, Life Sci Innovat, Seattle, WA USA

[10] McGill Univ, Div Cardiol, Ctr Hlth, Montreal, PQ, Canada

[11] Sci 37 Inc, Los Angeles, CA USA

[12] Novartis Pharma AG, Rotkreuz, Switzerland

[13] Johnson & Johnson, New Brunswick, NJ USA

[14] Flatiron Hlth, New York, NY USA

[15] Bayer US LLC Pharmaceut, Whippany, NJ USA

[16] AstraZeneca, Gaithersburg, MD USA

[17] Evidat Hlth, San Mateo, CA USA

[18] Amgen Inc, Thousand Oaks, CA 91320 USA

[19] Medidata, New York, NY USA

[20] Michael J Fox Fdn Parkinsons Res, New York, NY USA

[21] THREAD, Tustin, CA USA

[22] Healthagen Outcomes, New York, NY USA

[23] Scripps Hlth, Scripps Clin, Scripps Res Translat Inst, La Jolla, CA USA

[24] Scripps Hlth, Scripps Clin, Div Cardiovasc Dis, La Jolla, CA USA

[25] Sanofi R&D, Bridgewater, NJ USA

[26] Univ Pittsburgh, Pittsburgh, PA 15260 USA

[27] Duke Margolis Ctr Hlth Policy, Washington, DC USA

[28] Cerner Corp, Kansas City, MO USA

[29] Duke Univ, Sch Med, Duke Forge, Durham, NC USA

[30] Verily Life Sci Alphabet, San Francisco, CA USA

来源：

CIRCULATION | 2019年 / 140卷 / 17期

关键词：

group processes; randomized controlled trials as topic; technology; REAL-WORLD EVIDENCE; CARE; DESIGN; ACCESS; SITE;

D O I：

10.1161/CIRCULATIONAHA.119.040798

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

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.

引用

页码：1426 / 1436

页数：11

共 50 条

[1] Data-Driven and Technology-Enabled Trial Innovations Toward Decentralization of Clinical Trials: Opportunities and Considerations
Sehrawat, Ojasav
Noseworthy, Peter A.
Siontis, Konstantinos C.
Haddad, Tufia C.
Halamka, John D.
Liu, Hongfang
[J]. MAYO CLINIC PROCEEDINGS, 2023, 98 (09) : 1404 - 1421
[2] Technology-enabled population health
Sim, F.
Mackie, P.
[J]. PUBLIC HEALTH, 2018, 157 : A1 - A2
[3] Technology-enabled comprehensive characterization of multiple sclerosis in clinical practice
Baldassari, Laura E.
Nakamura, Kunio
Moss, Brandon P.
Macaron, Gabrielle
Li, Hong
Weber, Malory
Jones, Stephen E.
Rao, Stephen M.
Miller, Deborah
Conway, Devon S.
Bermel, Robert A.
Cohen, Jeffrey A.
Ontaneda, Daniel
McGinley, Marisa P.
[J]. MULTIPLE SCLEROSIS AND RELATED DISORDERS, 2020, 38
[4] Technology-enabled interprofessional education for nursing and medical students: A pilot study
Berg, Benjamin W.
Wong, Lorrie
Vincent, Dale S.
[J]. JOURNAL OF INTERPROFESSIONAL CARE, 2010, 24 (05) : 601 - 604
[5] Technology-Enabled, Evidence-Driven, and Patient-Centered: The Way Forward for Regulating Software as a Medical Device
Carolan, Jane Elizabeth
McGonigle, John
Dennis, Andrea
Lorgelly, Paula
Banerjee, Amitava
[J]. JMIR MEDICAL INFORMATICS, 2022, 10 (01)
[6] Technology-enabled content: Threat or opportunity?
Stear, EB
[J]. ONLINE, 1997, 21 (04): : 80 - 82
[7] Technology-Enabled Assessment of Functional Health
Cook, Diane J.
Schmitter-Edgecombe, Maureen
Jonsson, Linus
Morant, Anne, V
[J]. IEEE REVIEWS IN BIOMEDICAL ENGINEERING, 2019, 12 : 319 - 332
[8] Technology-Enabled Advances in Pain Management
Harrington, Linda
[J]. AACN ADVANCED CRITICAL CARE, 2022, 33 (03) : 240 - 243
[9] Anticipating Technology-Enabled Care at home
Reid, Louise
[J]. TRANSACTIONS OF THE INSTITUTE OF BRITISH GEOGRAPHERS, 2022, 47 (01) : 108 - 122
[10] Physicians in the era of technology-enabled diagnostics
Shah, Rashmee U.
[J]. NATURE REVIEWS CARDIOLOGY, 2023, 20 (04) : 215 - 216

← 1 2 3 4 5 →