Dear colleagues,
Welcome to the RWE & COVID-19 workgroup within the ISPE RWE Task Force!
As you may know early in 2020 a new ISPE RWE Task Force was established to promote scientific methods and standards, education, and policies related to the development, implementation, and interpretation of Real-World Evidence from Real-World Data studying the utilization, effectiveness, and safety of medical interventions in human populations. The Task Force 1) coordinates and consolidates the 30+ years of rich expertise in the science of pharmacoepidemiology research with regards to RWE coming from ISPE members in academia, government, service providers and biopharmaceutical industries from over 50 countries; and 2) builds collaborations with other societies, agencies, academic institutions, and patient advocacy groups with regards to RWE. The ISPE RWE Task Force is co-chaired by Helga Gardarsdottir, PharmD, PhD, FISPE and Wei Zhou, MD, PhD, FISPE.
Several Workgroups of the Task Force have been established during 2020 with leads/co-leads appointed for each one of them. These include: RWE and Collaboration with DIA, RWE and Collaboration with Duke Margolis, RWE and Medical Device, RWE and Oncology, RWE and Real-World Data Sources, RWE and Regulatory Decision Making, RWE Manuscript Development, RWE Methods Training, RWE Reproducibility and Transparency and Collaboration with ISPOR, RWE Statistical Methods, RWE Website Content.
Following the emergence and initial acute phase of the COVID-19 pandemic, an additional Workgroup was defined by the ISPE RWE Task Force: a Workgroup focusing on RWE in the context of COVID-19. The overall purpose of the RWE & COVID-19 Workgroup is that of coordinating the activities related COVID-19 within ISPE, and out-reach to other societies/organizations for collaboration opportunities, include workshops/manuscripts/projects, etc.
Similar as to how other RWE Workgroups had been stablished, a call for ISPE members interested in serving on the RWE & COVID-19 Workgroup was sent out and in September 2020. Ann McMahon and I were also contacted to co-lead this workgroup.
A first meeting by the RWE & COVID-19 Workgroup took place with a CORE team end of October 2020. During the call we shared and discussed some initial ideas on the areas and needs which this Workgroup could cover. A follow up call is taking place December 16th, 2020 with the CORE and EXTENDED Workgroup members.
The RWE & COVID-19 Workgroup will define over the next weeks its GOALS and ACTIVITIES. We will be use MY EXCHANGE to share Workgroup documents, updates, etc. and as a discussion platform.
Looking forward to working together!
Ann McMahon, MD, MS, FISPE and Montse Soriano Gabarró, MD, MSc, FISPE
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Montse Soriano Gabarro MD, MSc, FISPE
Head Partnerships and Integrated Evidence Generation Office
Bayer AG
Berlin
30468194270
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