Experts from St Petersburg University confirm compliance with requirements for clinical trials of a drug for liver diseases
A team of scientists established by the Centre of Expert Advice at St Petersburg University has analysed the protocols of clinical trials of a drug for the treatment of liver lesions. This drug was created by the Scientific and Technological Pharmaceutical Company "Polysan" Ltd. The University’s specialists found that the studies conducted met all requirements and recommended certain additions to improve the results in future.
At the request of the Scientific and Technological Pharmaceutical Company "Polysan", an interdisciplinary team of scientists from St Petersburg University analysed the results of clinical trials of a drug for the treatment of patients with liver damage. Today, the drug developed by the company is included in the national recommendations for use in clinical practice. However, as the customers note, the evaluation of the drug’s efficacy will reveal possible additional benefits of its use for certain categories of patients and, as a result, improve the recommendations for its use.
The clinical trial of the medicinal product is a well-designed and formulated study, the design of which meets the objectives and does not violate the principles of non-intervention (i.e. the medicinal products were administered to the patients as usual, without interference by the researchers) and biomedical ethics.
Mikhail Revazov, Director of the Centre of Expert Advice at St Petersburg University
"The University’s expert opinion also includes individual comments that do not affect the overall positive impression of the protocol but need to be corrected in future,"’ said Mikhail Revazov, Director of the Centre of Expert Advice at St Petersburg University.
In particular, the University experts noted that the assessment of the bilirubin fraction, which was previously missing, should be added to the study. This component is important for assessing liver function and detecting adverse haematological events. For example, elevated bilirubin levels may indicate impaired bile outflow or biliary tract problems such as bile duct stones or tumours blocking the bile ducts.
The Centre of Expert Advice at St Petersburg University has been operating since 2012 and is characterised by its interdisciplinary approach to research. For each request, a unique team of scholars is formed, allowing the centre to provide expert opinions on a wide range of issues — from agrochemical research to computer forensics — and conduct research at the intersection of sciences in more than 100 fields of knowledge.
Each year, St Petersburg University provides more than 1,000 expert opinions at the request of government agencies, including law enforcement agencies, as well as businesses and individuals. The centre also provides consulting, business development, digital technology implementation, and peer review services.
Only highly qualified employees of St Petersburg University are involved in the expert work, including: 1,104 Doctors of Science; 2,491 Candidates of Science; 40 Members and Corresponding Members of State Academies of Science; and 33 holders of the honorary title "Honoured Worker of Science of the Russian Federation".
The St Petersburg University experts also advised specifying the parameters of the coagulogram — a set of laboratory analyses of blood coagulation, which can help to detect any pathologies in the patient in time. To increase the effectiveness of the therapy, the specialists form the Centre of Expert Advice at St Petersburg Universityrecommended considering the possibility of doubling the daily dose of the drug — up to 800 ml per day.
Additionally, the Scientific and Technological Pharmaceutical Company "Polysan" Ltd received information on the classification of the drug to supplement the Administrative Regulations of the Ministry of Industry and Trade of the Russian Federation on the provision of a state service for issuing a document containing information on the stages of the technological process of manufacturing a medicinal product for medical use carried out in the territory of the Eurasian Economic Union. The experts from St Petersburg University confirmed that the production of the active substance of the drug includes the synthesis of the molecule, which allows the production process to be identified as a general class chemical reaction.
St Petersburg University, the oldest university in Russia, was founded on 28 January (8 February) 1724. This is the day when Peter the Great issued a decree establishing the University and the Russian Academy of Sciences. St Petersburg University today is a major centre for education and research. More than 20,000 students study here, and more than 15 major laboratories and 23 resource centres have been established as part of the country’s leading Research Park. Graduates of the University have been recipients of the Nobel and Fields Prizes on multiple occasions.
Recently, St Petersburg, the Northern Capital of Russia, officially introduced a new holiday — Day of St Petersburg University — which has been included in the St Petersburg Law ‘On holidays and commemorative days in St Petersburg’.
In February 2025, a ceremonial event was held, during which Roscosmos cosmonauts presented the University with the "300th anniversary of St Petersburg University" flag, which had travelled to the International Space Station and back.