Technology-Enabled Clinical Trials

Author:

Marquis-Gravel Guillaume1,Roe Matthew T.1,Turakhia Mintu P.23,Boden William4,Temple Robert5,Sharma Abhinav67,Hirshberg Boaz8,Slater Paul9,Craft Noah10,Stockbridge Norman5,McDowell Bryan11,Waldstreicher Joanne12,Bourla Ariel13,Bansilal Sameer14,Wong Jennifer L.15,Meunier Claire16,Kassahun Helina17,Coran Philip18,Bataille Lauren19,Patrick-Lake Bray1,Hirsch Brad20,Reites John21,Mehta Rajesh22,Muse Evan D.23,Chandross Karen J.24,Silverstein Jonathan C.25,Silcox Christina26,Overhage J. Marc27,Califf Robert M.282930,Peterson Eric D.1

Affiliation:

1. Duke Clinical Research Institute, Durham, NC (G.M.-G., M.T.R., B.P.-L., E.D.P.).

2. Center for Digital Health (M.P.T.), Stanford University, CA.

3. VA Palo Alto Health Care System, CA (M.P.T.).

4. Boston University and VA New England Health Care System, MA (W.B.).

5. U.S. Food and Drug Administration, Silver Spring, MD (R.T., N.S.).

6. Division of Cardiology (A.S.), Stanford University, CA.

7. Division of Cardiology, McGill University Health Centre, Montreal, QC, Canada (A.S.).

8. MedImmune, Gaithersburg, MD (B.H.).

9. Life Sciences Innovation, Microsoft, Seattle, WA (P.S.).

10. Science 37 Inc, Los Angeles, CA (N.C.).

11. Novartis Pharma AG, Rotkreuz, Switzerland (B.M.).

12. Johnson & Johnson, New Brunswick, NJ (J.W.).

13. Flatiron Health, New York (A.B.).

14. Bayer U.S. LLC Pharmaceuticals, Whippany, NJ (S.B.).

15. AstraZeneca, Gaithersburg, MD (J.L.W.).

16. Evidation Health, San Mateo, CA (C.M.).

17. Amgen Inc, Thousand Oaks, CA (H.K.).

18. Medidata, New York (P.C.).

19. The Michael J. Fox Foundation for Parkinson’s Research, New York (L.B.).

20. SignalPath, Raleigh, NC (B.H.).

21. THREAD, Tustin, CA (J.R.).

22. Healthagen Outcomes, New York (R.M.).

23. Scripps Research Translational Institute; Division of Cardiovascular Disease, Scripps Clinic, Scripps Health, La Jolla, CA (E.D.M.).

24. Sanofi R&D, Bridgewater, NJ (K.J.C.).

25. University of Pittsburgh, PA (J.C.S.).

26. Duke-Margolis Center for Health Policy, Washington, DC (C.S.).

27. Cerner Corporation, Kansas City, MO (J.M.O.).

28. Department of Medicine (R.M.C.), Stanford University, CA.

29. Duke Forge, Duke University School of Medicine, Durham, NC (R.M.C.).

30. Verily Life Sciences (Alphabet), South San Francisco, CA (R.M.C.).

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.

Publisher

Ovid Technologies (Wolters Kluwer Health)

Subject

Physiology (medical),Cardiology and Cardiovascular Medicine

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