Real world evidence studies: problems of terminology and classification

Goldina T.A.

doi:https://doi.org/10.17116/medtech20234501150

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Abstract:

Problems in terminology are typical for any developing area of knowledge including Real World Evidence. In particular, we deal with variability of terms (use of different terms and their meanings for the same definition) and questions of their motivation (use of various motivating factors leading to variability). Moreover, the terms «data», «study» and «Real World Evidence» in Russia are polysemantic and used in different meanings. Indeed, study is both data processing and source of routine practice data in the same time. Analysis of legislative documents of the Eurasian Economic Union (EAEU) shows that today they contain 2 phrases: routine clinical practice (term with certain definition) and real clinical practice (part of other terms without definition). We found similar problems in terminology at the global level analyzing www.clinicaltrials.gov. Understanding the development of terminology is significant regarding development and evaluation of classification of Real World Evidence studies. Real World Evidence was historically formed from pharmacoepidemiology and currently goes beyond this scientific discipline. The term «RWE studies» is complex and systemic. Its use in legislation may lead to conflicts between current legislation regulating a part of RWE study designs and new legislation that will regulate the RWE studies. That is, there may potentially be a situation of double regulation for some RWE designs. Therefore, the issues of classification of RWE studies and the use of this classification in legislation, especially in pharmacovigilance, registration and decision-making in healthcare, are extremely important. In this regard, there are new needs for further development, including the need for classification of RWE studies. Analyzing regulatory documents, guidelines and scientific publications, we formulated criteria to classify any RWE studies from traditional interventional to innovative hybrid researches. This approach makes it possible to indicate various study designs corresponding to RWE studies. Finally, structuring and systematization of knowledge in real world data and RWE studies are necessary for development of clear criteria in decision-making and application of RWE in healthcare.

Keywords:

real world data (RWD)

real world evidence study (RWE study)

real world evidence (RWE)

Authors:

Goldina T.A.

Sanofi Russia

Scopus AuthorID: 57370889200
ORCID: 0000-0002-2680-7035

Received:

29.11.2022

Accepted:

16.12.2022

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References:

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