On September 28, 2023, the IV annual scientific-practical conference with international participation "Real clinical Practice. Modernity and the future" were organized and held. The theme of the conference brings together leading experts in the field of RWD/RWE. The participants of the conference discussed the research tools of real clinical practice, the confirming value of RWE in modern medicine, legislation, and global perspectives in the world, Russian Federation, and the EAEU. A total of 27 reports were heard at the conference. Based on the results of the conference, a Resolution was developed, the text of which we offer you to familiarize yourself with. 

Real-world data (RWD) play an increasingly important role in traumatology and orthopedics, as evidenced by the rapidly growing number of publications using registry, administrative, and other databases. Each type of RWD source has its own strengths and weaknesses, as does each database. Before using a particular RWD source, a researcher should understand its advantages and limitations. Careful attention to data quality and the use of appropriate analytical methods may help alleviate concerns regarding the validity of orthopedic studies using RWD. This article describes the main types of RWD used in traumatology and orthopedics and provides a brief description of RWD. 

While the clinical validity of the use of allosteric regulation is known, scientists are working on the discovery of new methods for the development of allosteric drugs that can modulate the functions of enzymes, depending on the desired therapeutic effect, and have a broader safety profile compared with alternative drugs. Allosteric modulators are of increasing interest in medicine, some of which are already used in the clinic and some can potentially be used in real-world clinical practice. This article summarizes the current knowledge about allosteric modulation of receptors and their clinical prospects.

Since 2006, the Institute for Clinical and Economic Review (ICER) in the United States has assessed the clinical and economic value of innovative medical technologies and made pricing recommendations with the goal of achieving “sustainable access to highly effective treatments for all patients”. The methodological framework developed by ICER assesses the longterm economic value of health interventions and their availability in the shortest possible time.

This guidance provides recommendations to sponsors and investigators considering the use of externally controlled clinical trials to provide evidence of the safety and effectiveness of a drug product. In an externally controlled trial, outcomes in participants receiving the test treatment according to a protocol are compared with outcomes in a group of people external to the trial who had not received the same treatment. The external control arm can be a group of people, treated or untreated, from an earlier time (historical control), or it can be a group of people, treated or untreated, during the same period (concurrent control) but in another setting. The guidance addresses considerations for the design and analysis of externally controlled trials to study the effectiveness and safety of drugs, including discussion of threats to the validity of trial results from potential 

bias. Although various sources of data can serve as the control arm in an externally controlled trial, this guidance focuses on the use of patient-level data from other clinical trials or from real-world data (RWD) sources, such as registries, electronic health records, and medical claims. The guidance also describes considerations related to communicating with the FDA and ensuring access by the FDA to data from an externally controlled trial. This guidance does not address other types of external controls, such as using summary-level estimates instead of patient-level data. This guidance does not discuss details of the design and analysis of a natural history study nor the reliability and relevance of various sources of RWD that could be used in an externally controlled trial. Finally, this guidance also does not discuss considerations for using external control data to supplement a control arm in a traditional randomized controlled clinical trial. In general, FDA guidance documents do not establish legally enforceable responsibilities. Instead, guidance describes the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidance means that something is suggested or recommended, but not required.