2019 DecentralizedTrialsintheAgeofRe

(Khozin & Coravos, 2019) ⇒ Sean Khozin, and Andrea Coravos. (2019). “Decentralized Trials in the Age of Real-World Evidence and Inclusivity in Clinical Investigations.” In: Clinical pharmacology and therapeutics, 106(1). doi:10.1002/cpt.1441

Subject Headings: Clinical Study Participant Engagement.

Notes

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Quotes

Abstract

[[Decentralized clinical trials (DCTs)]] facilitate conducting studies outside the physical boundaries of traditional clinical research facilities. [[Decentralized clinical trials (DCTs)|They]] can extend the reach of clinical investigations to historically underserved populations while enabling incorporation of tools, such as digital health and telemedicine, for high-frequency remote monitoring of patients in real-world settings. DCTs require special attention to cybersecurity and data privacy protection laws and can be an efficient means of supporting a more patient-centered and inclusive clinical research enterprise.

References

1. The Center for Information and Study on Clinical Research. Public and Patient Perceptions & Insights Study <https:// www.ciscrp.org/download/2017-perceptions- insights-study-the-participation-experience/? wpdmdl=8770> (2017). Accessed January 17, 2019.

2. US Food and Drug Administration (FDA). Framework for FDA’s real-world evidence program <https://www.fda.gov/downloads/ ScienceResearch/SpecialTopics/ RealWorldEvidence/UCM627769.pdf> (2018). Accessed January 17, 2019.

3. Unger, J.M., Hershman, D., Fleury, M.E. & Vaidya, R. Association of patient comorbid conditions with cancer clinical trial participation. JAMA Oncol. https://doi. org/10.1001/jamaoncol.2018.5953. [ e-pub ahead of print]

4. Dodge, H.H., Zhu, J., Mattek, N.C., Austin, D., Kornfeld, J. & Kaye, J.A. Use of high-frequency in-home monitoring data may reduce sample sizes needed in clinical trials. PLoS One 10, e0138095 (2015).

5. Khozin, S., Pazdur, R. & Shah, A. INFORMED: an incubator at the US FDA for driving innovations in data science and agile technology. Nat. Rev. Drug Discov. 17, 529–530 (2018).

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	Author	volume	Date Value	title	type	journal	titleUrl	doi	note	year
2019 DecentralizedTrialsintheAgeofRe	Sean Khozin Andrea Coravos			Decentralized Trials in the Age of Real-World Evidence and Inclusivity in Clinical Investigations						2019