Changes to the EAEU rules, which introduce the concepts of RWD and RWE, may be considered by the Board of the Eurasian Economic Commission at the beginning of next year. It is planned that at the first stage it will be possible to use the RWE data when making changes to the registration dossier for the drug.

Trends in the field of clinical trials (CI) of drugs were actively discussed at the event. Peter Poulsen, Senior Market Access Manager at Pfizer (Denmark), spoke about the potential of using RWE (Real-World Evidence, RWE) and RWD data for decision making in the healthcare sector. RWE \ RWD is evidence collected on a regular basis from various sources based on the analysis of real data obtained from daily medical activities, for example, from hospital databases, biological banks, patient records. Real evidence can be directed to the study of different objects: specific drugs, the state of health of patients, a certain stage of the disease and the disease in general, certain areas of medicine, and many others.

At different stages of the drug development cycle, real evidence can be useful to different stakeholders. For example, during the development phase, they help regulators, specialized regulatory agencies, companies themselves, and patients assess the prospects for a future product. This information can then be directed to a wider range of stakeholders: healthcare professionals, medical institutions, regulators, patients and pharmaceutical companies. In addition, real evidence is powerful in assessing the economic dimension.

Peter Poulsen gave an example:

In Denmark, an RWE study was conducted that assessed the additional costs of medical care and social assistance for patients hospitalized with pneumonia. It was necessary to collect data from real routine clinical practice and assess the cost-effectiveness of including vaccine prevention against pneumococcal infection in the insurance coverage of citizens. As a result, it was found that the additional cost per patient hospitalized with pneumonia amounted to about $ 25,000 during the first six months from the date of diagnosis. In this case, data from actual routine practice was used as a starting point for economic analysis of health care. And this brought a result: following the results of the RWE / RWD study, an application was initiated for reimbursement of the costs of vaccination against pneumococcal infection for citizens at high risk of hospitalization with pneumonia, measures were taken to include immunization against pneumonia in insurance.

The experts also discussed technological innovations in the field of healthcare and pharmaceuticals, including electronic medical records, which became actively used during the COVID-19 pandemic. The Letter of the Ministry of Health of the Russian Federation dated 03/27/2020 provides recommendations for conducting CI of drugs in new conditions: for example, the use of remote methods of monitoring research participants, expanding interaction with patients at home using drug delivery and on-site collection of biological samples. With such a system, many data are stored on electronic media, which causes certain difficulties: it is necessary to comply with the requirements of legislation in the field of information protection, a chain of approvals with several instances, electronic signatures of all participants in the process, including patients, compliance with data storage periods.

Experts talk about the potential of using the Unified Medical Information and Analytical System (UMIAS) for remote monitoring of CI participants, since the platform includes most of the sections necessary for this: examination protocols, results of laboratory and instrumental studies, hospital discharge, vaccinations, health diaries.

According to Sergey Dubrovin, Director of Clinical Research at Pfizer, Russia, the joint efforts of regulators and the medical community could make it possible to adapt this system to the goals of CT:

At the moment, UMIAS does not have some of the necessary functions to carry out our tasks. But I am happy to say that there are all conditions for changing this situation. Close interaction between the pharmaceutical industry and government authorities could significantly simplify the procedures for conducting and monitoring clinical trials in the field of electronic medical records.

At the scientific and practical conference RegLek-2021, they also highlighted the issues of quality assessment and drug development, optimization of logistics processes in this area, ways to accelerate regulatory procedures and many other topics.

Source: https://pharmprom.ru/