Improving the quality of Russian pharmacogenetic research through the implementation of international standards: the role of the STROPS guideline

Introduction

Pharmacogenetics and pharmacogenomics have become an integral part of personalized medicine, allowing therapy to be optimized based on a patient's genetic characteristics. However, the value of such pharmacogenetic studies directly depends on the quality of their conduct and, equally importantly, on the completeness and transparency of their description in publications. In international practice, specialized guidelines such as STROPS (Strengthening the Reporting Of Pharmacogenetic Studies) are used to ensure a high level of such publications, serving as the evidence base for implementing pharmacogenetics into clinical practice [1].

In Russia, interest in pharmacogenetics is growing, as is the number of publications in this field. However, many studies still suffer from insufficient detail in methods, incomplete description of genetic data, lack of information on the quality of genotyping, and a lack of awareness regarding ethical and legal aspects of working with participants' genetic information. In light of upcoming changes in the Russian Federation legislation aimed at strengthening control over the handling of genetic data (Federal Law No. 86-FZ), the issue of correctly and completely describing pharmacogenetic studies becomes particularly relevant [2]. The new legal regulations require clear rules for the collection, storage, processing, and transfer of pharmacogenetic information, which should also be reflected in scientific publications.

The purpose of this article is to introduce Russian researchers to the STROPS guideline, explain its importance for improving the quality of publications, and propose adapted criteria that can be used in deciding on the publication of pharmacogenetic study results, taking into account Russian legal norms.

What is STROPS and why do we need it?

STROPS is an extension of the well-known STROBE (for observational studies) and STREGA (for genetic association studies) guidelines, specifically developed for pharmacogenetic studies [3, 4]. It contains 54 items covering all parts of a study: from rationale and design to interpretation of results and ethical aspects [1].

Implementing STROPS allows for:

• increasing the transparency and reproducibility of pharmacogenetic studies;

• reducing the risk of selective reporting (where only "positive" results are published);

• ensuring comparability of data across different studies;

• strengthening confidence in the results from the scientific community, regulators, and clinicians;

• facilitating the integration of data into international databases (such as ClinPGx, formerly known as PharmGKB), meta-analyses, and systematic reviews.

For Russian scientists, following STROPS is not only a step towards improving the quality of publications but also an opportunity to increase their visibility and citation in the international arena.

Adapted STROPS Criteria for Russian Researchers Considering Legislative Changes. Based on the STROPS guideline and considering the specifics of Russian legislation (in particular, the draft amendments to Federal Law No. 86-FZ), key points that should be given special attention when preparing publications are proposed (see table).

Recommendations for Authors Publishing in the Journal "Pharmacogenetics and Pharmacogenomics".

Starting in 2026, the journal "Pharmacogenetics and Pharmacogenomics" will introduce the STROPS guideline, in a version adapted for the Russian Federation, as the recommended reporting standard. When submitting manuscripts, authors will be asked to complete a checklist for compliance with key STROPS items, paying special attention to sections related to:

1. Ethical approval and informed consent.

2. Genotyping methods and quality control.

3. Legal aspects of handling genetic data, especially concerning population studies and possible data transfer.

The journal's editorial office will provide consultative support to authors on applying these standards.

Conclusion

Thus, the introduction of the STROPS publication standards for pharmacogenetic studies into Russian research practice is not a formality, but a necessary condition for enhancing the scientific rigor, legal correctness, and international recognition of domestic pharmacogenetic research. The upcoming changes in the legislation of the Russian Federation create a new framework for working with genetic data, making methodological transparency and compliance with ethical and legal norms not merely the good will of the researcher, but a mandatory requirement. The STROPS guideline, adapted to Russian specifics, can become a practical tool helping scientists not only to improve the quality of publications but also to design their studies in accordance with the legal framework in advance.

The journal "Pharmacogenetics and Pharmacogenomics" is ready to serve as a platform for implementing these standards and contribute to the formation of a culture of high-quality, reproducible, and ethically responsible pharmacogenetic science in Russia.

Table

Checklist for assessing the appropriateness of publication of pharmacogenetic study results based on the STROPS guidelines

⁵ Broad consent — the consent of a participant/patient for the repeated use of personal data and biomaterials in different studies, subject to confidentiality conditions.
⁶ Currently, the functionality of the Register of Domestic Pharmacogenetic Studies is being developed on the Unified Pharmacogenomic Platform, developed at the World-Class Genomic Research Center "Center for Predictive Genetics, Pharmacogenetics and Personalized Therapy" of the B.V. Petrovsky Russian Scientific Center of Surgery, Ministry of Education and Science of Russia.