Pragmatic Clinical Trial (PCT)

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A Pragmatic Clinical Trial (PCT) is a Clinical Trial that focuses on the correlation between treatments and outcomes in a healthcare system instead of focusing on proving causations for clinical endpoints.



References

2021a

  1. Tunis, SR; Stryer, DB; Clancy, CM (2003), "Practical clinical trials: increasing the value of clinical research for decision making in clinical and health policy", JAMA, 290 (12): 1624–1632, doi:10.1001/jama.290.12.1624, PMID 14506122
  2. Mullins, CD; Whicher, D; Reese, ES; Tunis, S; et al. (2010), "Generating evidence for comparative effectiveness research using more pragmatic randomized controlled trials", Pharmacoeconomics, 28 (10): 969–976, doi:10.2165/11536160-000000000-00000, PMID 20831305
  3. Schwartz, D; Lellouch, J; et al. (1967), "Explanatory and pragmatic attitudes in therapeutical trials", J Chronic Dis, 20 (8): 637–648, PMID 4860352

2021b

  • (Wikipedia, 2021) ⇒ https://en.wikipedia.org/wiki/Efficacy#Medicine Retrieved:2021-11-14.
    • QUOTE: In medicine, efficacy is the capacity for beneficial change (or therapeutic effect) of a given intervention (for example a drug, medical device, surgical procedure, or a public health intervention). Establishment of the efficacy of an intervention is often done relative to other available interventions, with which it will be compared. Specifically, efficacy refers to "whether a drug demonstrates a health benefit over a placebo or other intervention when tested in an ideal situation, such as a tightly controlled clinical trial." These studies focus on a primary parameter to be shown statistically different between placebo and intervention groups. Comparisons of this type are called 'explanatory' randomized controlled trials, whereas 'pragmatic' trials are used to establish the effectiveness of an intervention regarding also non-specific parameters. Effectiveness refers to "how the drug works in a real-world situation", and is "often lower than efficacy because of interactions with other medications or health conditions of the patient, sufficient dose or duration of use not prescribed by the physician or followed by the patient, or use for an off-label condition that had not been tested."

2017

2016

  1. Schwartz D, Lellouch J. Explanatory and pragmatic attitudes in therapeutical trials. J Chronic Dis 1967;20:637-648
  2. Thorpe KE, Zwarenstein M, Oxman AD, et al. A Pragmatic-Explanatory Continuum Indicator Summary (PRECIS): a tool to help trial designers. J Clin Epidemiol 2009;62:464-475
  3. Anderson ML, Griffin J, Goldkind SF, et al. The Food and Drug Administration and pragmatic clinical trials of marketed medical products. Clin Trials 2015;12:511-519
  4. 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-h2147
  5. Zwarenstein M, Treweek S, Gagnier JJ, et al. Improving the reporting of pragmatic trials: an extension of the CONSORT statement. BMJ 2008;337:a2390-a2390

2011

Figure 1: Schematic of the relationship between explanatory and pragmatic trials. The wide base of the pyramid depicts the relatively higher proportion of explanatory trials.

2003