Real-World Evidence: DM RWE will provide access to new and reliable clinical data
DM RWE, a clinical data management solutions provider, officially confirmed that it directs is putting its main resources into the development of the of Real-World Data solutions and the optimization of approaches to organizing clinical trials, by providing access to Real-World Evidence.
Given the growth in the use of Real-World Evidence (RWE), i.e. information based on patient health status and/or the delivery of health care routinely collected from a variety of sources, it is increasingly being used in the healthcare system for making decisions. The fact is, that unlike data from conventional randomized controlled trials, RWE includes a much broader array of disparate data from a wide variety of sources: electronic medical records, portable devices and gadgets, data from medical insurance companies, pharmacy data on prescription orders, registries of products and diseases, and outpatient records, etc. Thus, retrospective data and RWE allow one to go beyond the results of clinical trials with a limited number of patients, and provide a complete picture of how the drug will behave in real conditions. After all, even the post-marketing security system created by FDA does not provide the necessary amount of information if we take into account the individual genetic characteristics of each person.
New-generation biotherapeutic technologies are increasingly attracting the attention of regulatory bodies, health technology assessment agencies, pharmaceutical companies and sponsors of clinical trials. In the case of the first, RWE data will help make decisions about the safety and efficacy of drugs, as well as the reimbursement of drug costs. RWE will enable sponsors to better design and conduct research, to better articulate research hypotheses, and to more effectively and purposefully recruit patients to participate in research.
"Real-world Evidence is the most important current trend in the clinical trials sector. The development of this area will create new conditions and opportunities for modernization and expansion of clinical trials data, as well as significantly improving the processes of post-marketing drug monitoring." - Ekaterina Krinitsyna, Head of Business Development at DM RWE.
Last month the company signed an agreement with the Netrika Company an IT expertise center for project management in the public sector. Together with Netrika, the company will work to create a unified system of evidence of therapy efficacy in real life, based on the analysis of complex clinical data.
Vladimir Solovyov, Director for Development of Netrika:
"A lot of health data exists in digital form today. Our experience in the integration of medical information and processes allows us to place health information from different sources in a single platform. By joining forces with partners, we want to use the data for scientific and commercial purposes: to monitor the safety of drugs in real clinical practice, to compare different methods of treatment, to identify the medical needs of patients, and to find new areas for the use of drugs. Clinical trials based on real-world data are a global trend. The development of a domestic solution in this area will increase the competitiveness of the Russian pharmaceutical industry and accelerate the development of new drugs - an important task in the new reality created by the COVID-19 pandemic."
Alexey Loleit, Deputy General Director for Strategy and Product Development, at DM RWE:
"Big data is becoming more and more voluminous and reliable. Today, the most important issues that require careful consideration are systematization, validity and security.”
Earlier it was announced that DM RWE has joined the National Association of Biomedical Intelligence (NABI) to form part of a biomedical data operator.
“This company has extensive experience in the formation of specialized medical datasets, and it is, in our opinion, the leader in Russia,” commented Boris Zingerman, the Head of NABI Association.
The DM RWE portfolio includes over 200 projects for pharmaceutical and biotechnology companies and CROs. The company's products include applications such as EDC, IWRS and ePRO. Today the company is a member of professional communities such as CDISC, ACDM and SCDM. According to industry experts, the company has every chance of becoming breakthrough pioneers in the Russian market in the RWE / RWD segment, given the background of implemented cases in clinical trials, a wide partner network and the IT potential to create its own fully-fledged statistical and analytical platform for processing retrospective data.