Department for Clinical Trials and Evidence-Based Medicine

 

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Olga Bolshakova, MD, DSc
Chief Researcher

Brief History

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 developing the regulatory framework for the conduct of trials at the Centre, organizing the GCP trainings for the clinical trial staff, cooperating with regulatory authorities, sponsors and Ethics Committee as well as developing the system for preclinical and clinical trials at the Centre in general.

In 2010, the Clinical Trials Department was transformed into a research unit because the organization of drug trials is only a part, albeit an important one, of the work carried out by the department.

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).

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.

Major areas:

  • Providing organizational support for clinical trials (drugs, medical products and devices)
  • Cooperating with regulatory authorities and sponsors
  • Negotiating and executing agreements and other relevant study-related documents
  • Coordinating the activities of different departments on the matters related to the international multicentre clinical trials
  • Coordinating and providing technical support to the departments carrying out local trials
  • Compiling and analyzing the information related to the conduct of clinical trials
  • Organizing, preparing and delivering the advanced training course “The Basics of Clinical Trials” (together with the Postgraduate Training Department)
  • Arranging the record-keeping of clinical trials
  • Providing informational support for the trials

About Clinical Trials

A clinical trial is a medical research involving people that is conducted to evaluate the effectiveness and safety of a new drug or to expand the indications for use of already known/ approved ones.

Clinical drug trial is a study of the diagnostic, therapeutic, preventive, pharmacological properties of a medical product used in humans, animals, including the processes of absorption, distribution, modification and excretion. CT involves scientific assessment methods to obtain evidence on drug safety, quality and effectiveness, data on human and animal adverse reactions, interaction with other drugs and/or food products.

Multicenter clinical trial of a medical product is a clinical trial of a medical product for medical use conducted by a developer at more than one medical facility under a single clinical trial protocol.

International multicentre clinical trial of a medical product for medical use is a clinical trial conducted by a developer in various countries under a single clinical trial protocol.

Major publications

Bolshakova O., Sabatine M.S., Giugliano R.P., et al. Evolocumab and clinical outcomes in patients with cardiovascular disease. New England Journal of Medicine. 2017; 376 (18): 1713–1722. IF 37,91. Access link: https://www.nejm.org/doi/full/10.1056/nejmoa1615664#:~:text=In%20this%20dedicated%20cardiovascular%20outcomes,infarction%2C%20stroke%2C%20hospitalization%20for%20unstable.

Contacts:
Olga Bolshakova, MD, DSc, Chief Researcher
E-mail: bolshakova@almazovcentre.ru