| Understanding the Complete Journey of RWD, from Data Source to Final Analysis |
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As an industry, we are continuously accumulating experiences in working with real-world data (RWD) sources that collectively yield benefits – from enhanced generalisability of findings to facilitating faster approval timelines. However, these efforts are not without their challenges. RWD is usually far messier than clinical trial datasets that have been carefully collected in well-controlled environments. Additional refinements and cleaning are invariably needed with RWD. Among the many activities required, key items of focus include defining the applicable population(s), creating study measures (i.e. exposures, covariates, outcomes) based on an understanding of the data and related collection processes captured within the relevant RWD source(s), and determining the degree to which confounding and other biases may be present and the means by which to control them.
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| Presenter | Bio |
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| Jean-Marc Ferran, Independent Consultant/Qualiance Jean-Marc Ferran is an Independent Consultant based in Copenhagen with more than 1520+ years of experience in the Life Sciences industry. Prior to starting his company, Qualiance, he worked as a Statistician, Standards Manager and Director of Statistical Programming at Novo Nordisk and Ferring Pharmaceuticals. Jean-Marc has led the PHUSEJean-Marc is active in the Statistical Computing Environment, Data Anonymisation and RWE fields and work across customers and organisations in various capacities ranging from Project Manager, Subject Matter Expert to Statistician. In particular, he has been working with Novo Nordisk’s Rare Disease Data Science team since 2017 on exploratory work in the field of Growth Hormone Therapy. He also leads the PhUSE Data Transparency Working Group since 2014 and is an appointeda member of the EMA Technical Anomymisation Group and Health Canada Stakeholder Reference Group on Public Disclosure of Clinical Documents. Jean-Marc took various positions within PHUSE in the Annual Conference committee, Single Day Event committee and as a Board Member between 2014 and 2017. Jean-Marc alsochaired the PHUSEAnnual Conference in 2012 in Budapest , was a Director on the PHUSE Board from 2014 - 2017,and is a Lifetime Honorary member of the society for his significant contribution to the organisation over a number of years. |
| Berber Snoeijer, Clinline Berber Snoeijer started in clinical research in 1997 as a biometrician and has since then worked with clinical data in different functions. In 2001 she started a CRO – Biometric Support – aimed at the data management, data analysis and reporting of clinical trials. In 2011 she started as an R&D manager dedicated to investigating and utilising the potential of real-world data from electronic health records. This resulted in many different solutions including a full reporting system to give feedback information to clinical research professionals. Berber is experienced with software and database engineering, process engineering and improving efficient utilisation and interaction of people based on management drivers. Nowadays, she uses these skills and knowledge to help life science companies assess, design and improve business solutions and processes at smaller and larger scales. |
| Ariel Berger, Evidera Ariel Berger, MPH, is an Executive Director, Integrated Solutions, U.S. Database Analytics with the RWE group at Evidera, and is located in Massachusetts. Ariel helps lead the Database Analytics Business Unit, contributing to internal processes, staff development and training, and development of new customer offerings. He also designs and leads/advises on RWE and health economics studies, often involving complex methodologies and hybrid designs and disciplines, and strategic initiatives, such as data landscaping and evidence generation planning. Prior to joining Evidera, he was a senior consultant at Policy Analysis Inc. for approximately 13 years, during which time he led outcomes research studies, including retrospective database analyses; developed health economic models (both budgetary impact and cost-effectiveness models); performed literature reviews; and prepared product dossiers. Ariel has experience across therapeutic areas including pulmonary arterial hypertension, infectious diseases, oncology, cardiovascular disease, osteoarthritis, neuropathic pain, fibromyalgia, migraine headache, mental health disorders, end-stage renal disease, and ostomy/incontinence care. His related work has been published in peer-reviewed journals such as Surgical Infections, PAIN Practice, the Journal of Health & Productivity, the American Journal of Managed Care, Infection Control & Hospital Epidemiology, Annals of Pharmacotherapy, and BMC Pulmonary Medicine. His work has been presented at conferences such as the American Thoracic Society (ATS), the European Society of Clinical Microbiology and Infectious Diseases (ESCMID), the American Society of Nephrology (ASN), the Infectious Diseases Society of America (IDSA) and the International Society of Pharmacoeconomics and Outcomes Research (ISPOR). Ariel has an MPH with a concentration in epidemiology and biostatistics from the Boston University School of Public Health and a BA from Syracuse University. |
