Clinical Trials and Evidence-Based Medicine

Olga Bolshakova, MD, DSc
Chief Researcher

The Department for Clinical Trials and Evidence-Based Medicine was established at Almazov Centre in 2006 to organize, coordinate, guide and oversee the conduct of clinical trials.

The tasks of the Department include:

• Development of the regulatory framework for clinical trials at the Centre
• GCP trainings for the clinical trial staff
• Cooperating with regulatory authorities, sponsors and Ethics Committee
• Development of the preclinical and clinical trial system at the Centre in general.

Staff qualification is one of the most important components of ensuring the quality of clinical trials. A researcher, though being a highly qualified specialist in the field, might lack knowledge in Good Clinical Practice (GCP) and the Russian laws on clinical trials, and for this reason errors and deviations from the protocol may occur. Thematic advanced training in clinical trials includes courses on «The Basics of Clinical Trials» (organized together with the Postgraduate Training Department).

Since 2011, Almazov Centre has been conducting the onsite training cycles.

Given the expanding range of services and opening of the new unit for early-phase clinical trials, the clinical research unit, the Clinical Trials Centre, was established in 2014. In addition to the conduct of clinical and preclinical trials, bioequivalence studies, we provide a full range of services for scientific support of projects, from study design to clinical study report, as well as expert review and medical translations.

Since 2016, the Department has been conducting the research on domestic insulins (hyperinsulinemic euglycemic clamp tests in healthy volunteers and diabetes patients).

Since 2017, we have been conducting clinical trials in pediatrics (pediatric hematology, cardiology, neurology) with MRI, PET/CT scans and functional diagnostic tests (echocardiography, ECG, bodyplethysmography, ergospirometry), ophthalmology.

Since 2019, Almazov Centre has been included in the list of organizations entitled to conduct clinical trials of medical devices within the EurAsEC.

The main areas in 2019 were clinical testing of medical devices, hematology and cardiology.

In 2019, the Department increased the number of new agreements in all areas – clinical trials of drugs, medical devices and diagnostic studies, including for external facilities (CT, MRI, PET, laboratory tests, ophthalmological examination and functional testing).

Year 2020 showed a new record in the number of agreements. Clinical trials were conducted under 207 agreements of the Research Management Department. A total of 47 new agreements were signed in 2020, including 25 for drug clinical trials, 6 for diagnostic studies, and 16 for medical device testing.

In 2020, Almazov Centre conducted two studies in patients with COVID-19:

• R-Pharm Company: An International, Multicenter, Randomized, Double-Blind, Adaptive Placebo-Controlled Study of the Efficacy and Safety of a Single Administration of Olokizumab and RPH-104 With Standard Therapy in Patients With Severe SARS-CoV-2 Infection (COVID-19), phase 2/3;
• Biocad Company: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Adaptively Designed Clinical Trial of the Efficacy and Safety of Levilimab (BCD-089) in Patients With Severe COVID-19, phase 3.