External control during RWD/RWE research: a methodological approach
https://doi.org/10.37489/2588-0519-2022-2-21-27
Abstract
At the moment, randomized controlled trials (RCTs) are the gold standard for providing evidence of the effectiveness and safety of medicines. If it is impossible to randomize and create an internal control group, alternative methods of collecting evidence are used, for example, the use of so-called external control groups created, among other things, based on real world data (RWD). The increase in the number of studies using RWD and external control is clearly visible in oncology, where there are problems with randomization classically. Meanwhile, this trend is of concern and requires a better understanding of the acceptability of using external control groups and validation of RWD.
About the Authors
A. A. Zhuravkov
Academician I.P. Pavlov First St. Petersburg State Medical University of the Ministry of Healthcare of Russian Federation
Russian Federation
Russian Federation
Andrei A. Zhuravkov - Post-graduate student, Department of Clinical Pharmacology and Evidence-Based Medicine I.P. Pavlov SPbSMU MOH Russia.
Saint-Petersburg.
A. S. Kolbin
Academician I.P. Pavlov First St. Petersburg State Medical University of the Ministry of Healthcare of Russian Federation
Russian Federation
Russian Federation
Alexey S. Kolbin - Dr. Sci. (Med.), Professor, Head of the Department of Clinical Pharmacology and Evidence-Based Medicine, I.P. Pavlov SPbSMU MOH Russia.
Saint-Petersburg.
SPIN code: 7966-0845
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Review
For citations:
Zhuravkov A.A., Kolbin A.S. External control during RWD/RWE research: a methodological approach. Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice. 2022;(2):21-27. (In Russ.) https://doi.org/10.37489/2588-0519-2022-2-21-27
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