Decentralized Clinical Trial (DCT)

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A Decentralized Clinical Trial (DCT) is a clinical trial that involves decentralized data collection (from patients).



References

2021a

  1. Clinical Trial Transformation Initiative, CTTI Recommendations: Decentralized Clinical Trials 2 (2018), available at https://www.ctti-clinicaltrials.org/sites/www.ctti-clinicaltrials.org/files/dct_recommendations_final.pdf.

2021b

2021c

2021d

2021e

  1. Clinical Trials Transformation Initiative. Decentralized Clinical Trials. Published September 2018. https://www.ctti-clinicaltrials.org/projects/decentralized-clinical-trials
  2. Ledford H. (2020). The coronavirus outbreak could make it quicker and easier to trial drugs. Nature, 582, 172. https://doi.org/10.1038/d41586-020-01524-0

2021f

2021g

Central Illustration: Decentralized Clinical Trials. In decentralized clinical trials, patient visits for healthcare provider interaction and laboratory tests are localized in the patient’s community. Medications for the study are provided either directly to the patient or the local healthcare facility. Other interactions, including patient recruitment and monitoring occur via internet interactions, with data secured and maintained virtually.

2020a

2020b

2020 AdaptingtoaPandemicConductingOn Fig1.png
Figure 1: Decentralized versus traditional clinical trial models. Adapted from Khozin and colleagues[5].
2020 AdaptingtoaPandemicConductingOn Fig2.png
Figure 2: Primary and satellite clinical trial sites. Adapted from Sabesan and colleagues [2].
  1. DiMasi JA, Grabowski HG, Hansen RW. Innovation in the pharmaceutical industry: new estimates of R&D costs. J Health Econ 2016;47:20–33
  2. 2.0 2.1 Sabesan S, Zalcberg J. Telehealth models could be extended to conducting clinical trials-a teletrial approach. Eur J Cancer Care 2018;27:e12587.
  3. Coravos A, Goldsack JC, Karlin DR, Nebeker C, Perakslis E, Zimmerman N, et al. Digital medicine: a primer on measurement. Digit Biomark 2019;3: 31–71.
  4. Sherman RE, Anderson SA, Dal Pan GJ, Gray GW, Gross T, Hunter NL, et al. Real-world evidence - what is it and what can it tell us? N Engl J Med 2016;375: 2293–7.
  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 2018;17:529–30.