Data Matrix is the only company in the field of RWE which has been included in the regulatory sandbox
This was announced by Vadim Merkulov, Deputy General of the FSBI «SCEEMP» at the Ministry of Health of the Russian Federation, M.D., Professor at the International Scientific-Practical Conference “RWD/RWE Instrument Tools for Real Clinical Practice Today and Tomorrow”.
The conference was attended by all the significant players of the international and Russian market, as well as authorities interested in advancing the research field of real clinical practice.
RWE, routine practice research that reflects the practical experience of patients in real situations, is a new global trend that will radically change the pharmaceutical and medical industries in the future. The use of this data in addition to the data obtained from classical randomized clinical trials will make it possible to improve access to safe and effective treatment for the population.
The participation of Russian centers in international and Russian clinical trials has led to there being more and more doctors in routine clinical practice that are switching to an objective safety assessment, which adheres to international clinical research practice standard criteria for assessing the degree of severity. The same applies to the evaluation of effectiveness, in which an assessment of the objective response of the disease begins, taking into account the standards previously applicable only in clinical trials.
On July 2, 2021, the President signed Federal Law No. 331-FZ «On Amendments to Certain Legislative Acts of the Russian Federation» in connection with the adoption of the Federal Law «On Experimental Legal Regimes in the Field of Digital Innovations in the Russian Federation». Data Matrix, which conducts research of routine clinical practice (RWE) based on depersonalized data from electronic medical records “is one of the seven participants of the ELR program considered, and the only one in the field of Real World Evidence,” Vadim Merkulov pointed out in his statement. “Thanks to this experimental legal regime, pharmaceutical and biotechnology companies will receive a legally competent provider of routine clinical practice data (RWD) and the opportunity to conduct RWE research on Russian data.