Clinical Trial Program for Drugs for the Treatment of Herpes Labialis: An Analysis of FDA Guidance

INTRODUCTION. Herpesvirus infections are among the most common viral diseases in humans and have been classified by the WHO Regional Office for Europe as a group of diseases that determine the future of infectious pathology. Currently, the Russian Federation and the Eurasian Economic Union (EAEU) lack documents providing recommendations on conducting clinical trials of drugs for the treatment of herpes labialis that would establish the required scope of data for the registration of new products. Therefore, it is pertinent to analyze global regulatory practices, including the approaches of leading agencies such as the US Food and Drug Administration (FDA).

AIM. This study aimed to assess the feasibility of using and adapting the FDA methodological approach when developing a Russian guidance on planning a clinical trial program for new drugs for the treatment of herpes labialis.

DISCUSSION. A review of regulatory and methodological documents revealed that currently only one specialized guidance exists on conducting clinical trials of new drugs for the treatment of herpes labialis, prepared by the FDA (FDA Guidance). The FDA Guidance defines the specific features of conducting clinical pharmacology studies and confirmatory clinical trials (selection of the study population, design and duration of clinical trials, selection of primary and secondary efficacy endpoints, and safety assessment), as well as the specific features of conducting confirmatory clinical trials in children. A comparison with the regulatory documents of the Russian Federation and the EAEU showed that the methodological solutions presented in the FDA Guidance do not contradict the general principles of clinical trial conduct established in the current documents.

CONCLUSIONS. The provisions of the FDA Guidance meet all the requirements necessary for planning a clinical trial program and can serve as a basis for the guidance being developed for conducting clinical trials in the Russian Federation and the EAEU member states, taking into account regional specifics.

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