Main topic - Real World Data / Real World Evidence (RWD / RWE): Role in Pharmacoeconomics and Health Technology Assessment.

Basic definitions of RWD in the world and RF will be given. The current situation is described. The main methods of RWD data collection are highlighted - from clinical trials to database analysis. The directions of practical application are shown - from pharmacovigilance, registration and cost recovery. Recommendations and conclusions for the implementation of the RWD / RWE paradigm in Russia are offered.

Also, a brief description of the US regulatory experience will be given. The applicable EAEU regulations are described. Suggestions are made in terms of improving the legal framework in the field of regulation of RWD / RWE in and the EAEU.

The definitions of evidence-based medicine are proposed, the apparent conflict between the evidence and the features of RWD collection is considered, the possibilities for improving the planning of RWD studies and increasing their evidence are shown with examples from the field of oncology.

A detailed description of the clinical register will be presented: definition, method of data collection, method of their analysis. The possibilities of using the clinical register as a source of RWD data are shown.

Practical examples of the use of real clinical practice approaches will be given, a systematic experience of conducting research under the limitations of a pandemic will be presented, tools and methodology for application will be proposed.

It is planned to discuss the role of RWE research in collecting information about HP, emphasizing the special value of research of this kind. The question of the methodology for conducting studies dedicated to the assessment of the safety profile is being discussed.

The experience of evaluating the available data from randomized clinical trials and real clinical practice based on the results of indirect comparisons of CDK 4/6 inhibitors for combination therapy of mBC will be presented.

They will consider the current situation with obtaining information from up-to-date databases on the medical care provided to patients with malignant neoplasms. An analysis of information sources is given, methodological approaches are proposed that allow obtaining the most complete information about the treatment of patients with malignant neoplasms.

We are waiting for you on November 9 14: 15-16: 45. Hall number 5. International Exhibition Center CROCUS EXPO.

The organizers conduct online broadcasting.

Program https://rosoncoweb.ru/events/2021/11/09/