Pragmatic clinical trials
https://doi.org/10.37489/2588-0519-2020-3-52-60
Abstract
Pragmatic clinical trials (PCTs) allow combining the advantages of observational trials in real-world evidence with the scientific rigor of randomized clinical trials (RCTs), and thereby provide more effective answers to questions of real-world evidence.
Aim. Assessment of differences in conducting RCTs and PCTs, as well as analysis of the features related to conducting PCTs at different stages.
Methods. An analysis of publications in the period from 1999 to 2017 was conducted to identify data on PCTs.
Results. There are significant differences in conducting classic RCTs and PCTs. First, PCTs use more flexible inclusion criteria and differ in the approach to choosing an investigator’s site. Also, the procedure for obtaining informed consent has significant differences from that of classical RCTs; alternative options are proposed but a unified approach has not yet been developed. When conducting PCTs, monitor intervention should be minimal in order not to interfere in the routine therapy, which, however, can lead to a violation of reporting. A possible solution may be remote data collection.
Conclusion. PCTs represent a huge potential for studying the effectiveness of drugs in real-world evidence. However, despite a significant increase in the number of such trials, there are still a sufficient number of points that need to be resolved.
About the Authors
O. R. Shevchenko
FSBEI HE I.P. Pavlov SPbSMU MOH Russia
Russian Federation
Russian Federation
Shevchenko Olga R. - Post-graduate student, Department of Clinical Pharmacology and Evidence-Based Medicine
St. Petersburg
A. S. Kolbin
FSBEI HE I.P. Pavlov SPbSMU MOH Russia;
FSBEI HE “Saint-Petersburg State University”
Russian Federation
Russian Federation
Kolbin Alexey S. - D. Sci. in Medicine, Professor, Head of the Department of Clinical Pharmacology and Evidence-Based Medicine, FSBEI HE I.P. Pavlov SPbSMU MOH Russia; Professor of the Department of Pharmacology, Medical Faculty, SPbSU
SPIN code: 7966-0845
St. Petersburg
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Review
For citations:
Shevchenko O.R., Kolbin A.S. Pragmatic clinical trials. Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice. 2020;(3):52-60. (In Russ.) https://doi.org/10.37489/2588-0519-2020-3-52-60
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