Planning a Clinical Development Programme for Medicinal Products for Functional Gastrointestinal Disorders

INTRODUCTION. Functional gastrointestinal disorders (FGIDs) are a heterogeneous group of disorders characterised by non-specific clinical signs that may occur in various diseases of the digestive system. Currently, there are no guidelines for conducting clinical trials of medicinal products for FGIDs in the Russian Federation. It is, therefore, essential to develop such guidelines taking into account the current requirements for marketing authorisation in the Eurasian Economic Union (EAEU).

AIM. This study aimed to provide a systematic overview of international approaches to clinical trials of medicinal products for FGIDs, which will inform further development of a guideline for conducting these clinical trials in the Russian Federation.

DISCUSSION. The gold standard for assessing the safety and efficacy of pharmacotherapy is a randomised, double-blind, parallel-group, placebo-controlled trial. The design of a clinical trial depends on a number of factors, including the type and severity of the FGID, the demographics of the target population, the selected endpoints, and the presence (or absence) of specific symptom combinations and biomarkers. To plan a clinical trial that meets the principles of evidence-based medicine, the Rome IV criteria should be used consistently at all stages of treatment strategy development and assessment.

CONCLUSIONS. Following the described fundamental principles for the development of clinical trial programmes for medicinal products for FGIDs will ensure that clinical trials are planned and conducted in full compliance with international approaches and ethical standards. The development of a Russian guideline for planning clinical trials of the safety and efficacy of medicinal products for FGID management will facilitate selecting the optimum treatment method from a wide spectrum of available treatments.

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