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.

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:

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:

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

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.

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

Section of PublicationCompliance CriteriaCommentaryCompliant: Yes / No / Not ApplicableAbstractStructured summarySections highlighted: relevance, study objective, materials and methods, results, conclusions / summary  The results section indicates the "magnitude" of the pharmacogenetic effectOdds ratios / risk ratios, confidence intervals, p-values are stated  KeywordsIncluding the keywords: pharmacogenetics and/or pharmacogenomics Introduction / BackgroundAn analysis of previously published results of pharmacogenetic studies (on the disease, on the drug or drug group) is conducted, indicating search keywordsA search was conducted in international databases (e.g., PubMed and others)  The selection of candidate genes and polymorphisms studied in the research is justifiedA search was conducted for domestic studies in Russian databases (e.g., eLibrary.ru and others)  The study objective is clearly formulatedReferences are provided to "functional" studies explaining the possible role of the gene product in the pharmacokinetics or pharmacodynamics of the drug. References are given to studies on the frequency of the studied polymorphisms, including in the Russian population (if data are available for various ethnic groups of the Russian Federation)  The type and design of the study (cohort, case-control, etc.) are indicatedThis should state whether the study is "associative" or prospective ("clinical validation"¹ of an algorithm/model for personalizing pharmacotherapy based on pharmacogenetic testing) Materials and MethodsThe study design is described, indicating the method of forming patient groups²The method of forming patient groups is indicated  The estimated sample size calculation is providedOutcomes (including measurable efficacy and safety criteria) are specified  The medical organization or clinical department where patient enrollment took place is namedIf patients were enrolled based at a partner medical organization of the research center, the existence of a valid agreement must be indicated  Patient inclusion/exclusion criteria are describedVerification of the nosology must be carried out in accordance with current Russian clinical guidelines published in the Ministry of Health's clinical guidelines rubricator https://cr.minzdrav.gov.ru  Clinical and demographic characteristics of patients included in the study are providedIt is recommended to present this in a table, including information on concomitant diseases and concomitant drug therapy  Information on participants' self-identified racial and ethnic background is providedThe method for verifying racial and ethnic background (e.g., self-identification by both parents) should be provided  Information on the absence or presence of familial relationships among study participants is providedFirst and second-degree relationships are considered  Information is provided on all drugs used and their dosage regimensDrug use complies with the instructions for medical use from the State Register of Medicines (GRLS)³   Drug use complies with current clinical guidelines published in the Ministry of Health's clinical guidelines rubricator https://cr.minzdrav.gov.ru  Methods for monitoring patient adherence to drug therapy (if used) are specified   The algorithm for personalizing pharmacotherapy based on pharmacogenetic testing is providedApplicable for prospective studies ("clinical validation" of an algorithm/model for personalizing pharmacotherapy based on pharmacogenetic testing)  The studied genetic variants are indicated⁴Genetic variants are indicated by rs numbers   It is specified which allelic variants are "minor" and which are "wild-type" Genetic AnalysisMethods of biomaterial collection, storage conditions, and DNA extraction are described   The PCR or sequencing method, equipment, and reagents are described   The quality control method for genetic studies is indicated   The laboratory where the study was conducted is named  Statistical AnalysisShould reflect the use of corrections for multiple comparisons and a description of bioinformatic processing (when using sequencing)  Ethical Review and Legal AspectsInformation about participants or their legal representatives signing informed consent must be providedFor studies involving minor patients over 15 years of age, informed consent must be signed by the patient and their legal representative  The date and protocol number of the Ethics Committee that issued approval must be providedThe protocol must reflect the Ethics Committee's approval for the collection and use of genetic data  If using biomaterials from a biobank collection, indicate the existence of broad consent for use⁵   It must be stated that genetic data and biomaterial are not transferred outside the Russian FederationExcept for cases provided for by law, which must be specified  The study is registered on the Unified Pharmacogenomic Platform⁶The registration number of the study must be provided ResultsThe distribution of identified genotypes is checked for compliance with the Hardy-Weinberg equilibriumIn case of deviation, the deviations must be explained  Study limitations are presentedPossible sources of bias, including insufficient power, must be indicated FundingSources of funding for the entire study or parts of the study are presentedThe source of funding and the sponsor's role in study design, data collection, analysis, and publication (if any) must be indicated  The presence / absence of a conflict of interest is stated  DiscussionA discussion is presented in comparison with similar foreign and domestic studies, prospects for further research, and the practical significance of the results  

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.