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Editorial
. 2016 Mar 1;133(9):823-5.
doi: 10.1161/CIRCULATIONAHA.116.020976.

Standards for Clinical Research: Keeping Pace With the Technology of the Future

Elliott M Antman  1 , Barbara E Bierer  2
Affiliations
Editorial

Standards for Clinical Research: Keeping Pace With the Technology of the Future

Elliott M Antman et al. Circulation. .
No abstract available

Keywords: Editorials; clinical trial; ethics; research ethics; research methodology.

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Figures

Figure 1
Figure 1
Interface of the Continuum of Clinical Research and Research Standards. On the left is shown the spectrum of trials where research subjects are randomized to medical interventions and followed prospectively. These range from those conducted under ideal circumstances to those conducted under usual conditions of clinical care. A mapping tool is shown where investigators use a Likert scale to score a trial design along nine domains as to whether it is predominantly explanatory (score=1) or pragmatic (score=5). The typical purpose of the trial type and the ethics and focus of research standards are shown at the bottom left. The core principles of human investigation apply across the spectrum, but the focus of the research standards varies. Big Data analyses incorporate inputs (not shown) of previously acquired data into a predictive analytic system and generate recommendations for more precise care of individuals and populations. Depending on the type of information, it is important to be certain that the data are acquired in accordance with the core principles of human investigation (shown with dashed lines, since this may not be applicable in all circumstances). Here the research standards need to focus on privacy and data sharing. See text for further discussion. The diagram on the left is reproduced with permission from Ref : Loudon K, Treweek S, Sullivan F, Donnan P, Thorpe KE, Zwarenstein M. The PRECIS-2 tool: Designing trials that are fit for purpose. BMJ. 2015;350:h2147.
See this image and copyright information in PMC

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References

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