Regulatory sandbox for RWE projects explained at a conference by Data MATRIX
On December 2nd 2021, the business meeting: "Regulatory sandbox: a new reality of RWE for pharmaceutical business" was held at Sechenov University. The purpose of the event was to discuss the role of the new regulatory regime for pharmaceutical companies, explain its mechanism, and form a common vision of problems, challenges and opportunities for industry representatives.
In his welcoming speech, Data MATRIX, outlined why the recently approved law on the experimental legal regime will turn out to be an important decision for the implementation of innovations in the practice of medicine. He also reminded listeners that Data MATRIX is the only company which is initiating a track on the formation of EPR for big data in medicine. Several months ago Russian President, Vladimir Putin, signed off on the the law: "On Experimental Legal Regimes in the Sphere of Digital Innovation in the Russian Federation," which states that "research of routine clinical practice (Real World Evidence; RWE) is widely used abroad and is a fundamental approach both in terms of scientific and medical data accumulation, and in terms of forming a comprehensive evaluation of diagnostic methods, drug and non-drug treatment, prevention and rehabilitation. The use of research results allows the evaluation and optimization of clinical guidelines and standards of care to improve their clinical and economic effectiveness, as well as their pharmacovigilance activities.
"Transitions to new technologies are very important, but in the process of obtaining results that will subsequently be used by an unlimited number of people, someone needs to take the first step. Sechenov University, is a leader in Medical Science and Education, and a platform where science, business and regulators actively and fruitfully interact, introducing new technologies," commented Vadim Tarasov.
Participants of the first panel session: "RWE against the backdrop of a global trend", along with discussion chairperson, Vasily Ryazhenov, Head of the Department of Regulatory Relations in the Circulation of Medicines and Medical Devices of the First Sechenov Moscow State Medical University, discussed the position of regulators and recent significant legislative changes in Russia in relation to RWE/RWD.
"The target model of the medical digital circuit is based on the principle of single entry and multiple use of data. The creation of a single national platform with different specialists with different levels of access and data validation capabilitiesis a necessary step in terms of the challenges of digital transformation of healthcare. And here everyone, we, as a system integrator, and the Ministry of Health of the Russian Federation, are interested in ensuring that this is implemented on a user-friendly interface for doctors," - Mikhail Levin, Head of the Medical Directorate of Tsifromed.
The second session was devoted to the discussion of best practices and mechanisms for the formation of experimental legal regimes, and legal aspects of data use, as well as the removal of legal barriers in industry regulation. The discussion chairperson, Alexander Panov, head of BGP Litigation's Healthcare practice, also raised the issues of cybersecurity, data privacy and medical secrecy. Maria Savostyanova, Senior Associate at Sanofi, agreed with Ivan Zaraisky, BGP Litigation lawyer, about the importance of balancing risk withinnovation, while also keeping in mind the interests of the public.
"During the implementation of the EPR, the initiative proposal needs to propose parameters for handling data. In our view, the most important metrics today are data reliability, data volatility, data type, visualization, and data benefit. And speaking of benefits, we focus on the benefits for citizens, society and the state," - Evgenia Meshkova, Head of Legal Initiatives of Development and Planning Department of the Skolkovo Foundation.
In the session: "RWD in Russia: quantity turning into quality", Boris Zingerman, General Director of the NBMH Association, raised the issue of the possibility of enriching medical data for RWE with lifestyle data from other information sources.
"Obviously, the Data MATRIX project is a flagship project in every respect and opens up great opportunities for datasets. Thus, the launch of the regulatory sandbox should provide the necessary impetus for the industry to commercialize theits wide repertoire of digital tools."
The final session was with speaker- representatives of R-Pharm, Janssen Pharmaceuticals and Novartis, and participants shared their experiences, openly discussing the barriers of RWD research planning methodology and RWD analysis.