EMWA goes virtual!
Join us for EMWA’s third virtual Expert Seminar Series (ESS) 2020 on medical communications
Date: Tuesday, 1 December 2020, from 13:30 to 16:30 CET (Please ensure you check the time for your location prior to the event).
Real-world evidence (RWE) has attained an enormous significance in public health, regulatory policies, and pharmacoeconomics. To address the impact of RWE on the medical writing industry EMWA’s ESS 2020 on medical communications will focus on the role of real-world evidence in medical publishing.
Please email head office with any questions or accessibility concerns.
Maria Koltowska-Häggström (session Chairperson)
Preparation, submission, and publication of RWE studies: a publisher’s perspective
Andrea Bucceri, DovePress (Italy)
The importance of real-world evidence (RWE) has been increasing in various areas of medical research over the last few years, including: drug-development, medical devices, regulatory and healthcare decision-making. This has led to an increased number of submissions of RWE studies to medical journals, in order to make these important data available to the relevant audiences and decision-makers. There are, however, different perspectives and opinions regarding the interpretation of RWE results and the way they are reported. This session will focus on a publisher’s views on the publication of different types of RWE studies and it will provide suggestions on how to prepare RWE manuscripts for submission, choose the appropriate journal for publication, address reviewers’ criticisms and tips for preparing a potential re-submission. This session is aimed at improving the audience’s understanding on how to deal with the most relevant issues in the publication of RWE studies in medical journals.
RWE writing – what’s different from reporting randomised controlled trials
Thomas Wagner, Merck KGaA (Germany)
How should documents for RWE non-interventional studies be prepared by medical writers. In particular, how does writing of these documents differ from writing based on randomized controlled clinical trials. What needs extra care in these documents, e.g., regarding description of methodology and results, discussion and interpretation of data. What are the key elements of communicating the specifics of RWE study design, results, discussion and interpretation and how can appropriate study protocols, study reports, and scientific publications be prepared. What specific writing and reporting techniques can be used to present the results in a scientific valid and convincing way.
Practical issues in putting together publications on RWE and how to identify, avoid, and plan ahead of them
Phil Leventhal, Evidera (France)
Writing publications on real-world evidence (RWE) can be especially challenging. A main reason is that, unlike randomized clinical trials (RCTs), RWE studies, by design, do not have fixed, predetermined primary outcome measures or measures of success, so the results and analyses in a RWE study can change as the project advances or even after writing begins. Another important challenge is that publications on RWE studies may not be as well thought out as those on clinical trials because reporting guidelines and requirements are not as strict. Finally, in a RCT, methods and results are usually very well documented and the statistical analysis plan is established, whereas in RWE studies, the methods and results may be provided in a variety of file formats and may be incomplete or only available as draft versions to be sorted out by the publication writer. Together, these issues can add substantial complexity to the project, resulting in avoidable delays and added expense. In this presentation, I will discuss these and other practical issues and provide some ideas on how to identify, avoid, and plan ahead for them.
RWE manuscript preparation: evaluation of clinical data from a medical device perspective
Jasminka Roth, The Tao Of Excellence (Switzerland)
Putting a medical device on the market is widely seen as a linear process with two separate stages, namely pre- and post-market. These tend to be independently managed, and although they rely on each other they are unlikely to know each other’s regulatory requirements or the ways in which they could collaborate to help a product to thrive on the market.
In this two-part divide of pre- and post-market, the observational data of real-world evidence (RWE) have not traditionally been a focus for pre-market clinical teams. Now, however, the EU’s new medical device regulation (MDR) and in vitro diagnostic medical device regulation (IVDR) radically reinforce the regulatory requirements for clinical trials for pre- and post-market, citing these as vital to ensuring the safety and performance of a product on the market.
Whilst this talk defines the framework of these new regulatory requirements, it will also highlight the fact that RWE can now be used and shared to support the regulatory requirements for a device. The MDR and IVDR essentially reframe RWE as an untapped resource, one that can secure funding and reimbursement, rapidly contribute to improving a product or even lead to more innovation.
Alongside this, new technology now enables us to review, analyse and utilise clinical data from real-world applications for regulatory purposes, health technology assessments and more. This access gives us the ability and opportunity to reframe pre- and post-market processes as a “virtuous circle”. We can design clinical trials with the RWE manuscript in mind and in turn use RWE to influence new clinical trials that can support the lifecycle of a product on the market.
15:55 – 16:30
Panel discussion with speakers
Moderator: Maria Koltowska-Häggström
EMWA is offering a special price for this third virtual ESS €75 for EMWA member and €100 for non-members.
About our speakers:
Maria Kołtowska-Häggström (session chairperson) runs Proper Medical Writing, the first Polish medical writing agency. Between 1991 and 2013, she worked within the pharmaceutical industry where she gained experience in RWE through her wide-ranging research in large databases. Maria was a leading member of numerous research groups investigating pituitary disorders managed in the real-life clinical setting and has an extensive track record of quality of life and patient-reported outcomes research. She has authored >80 peer-reviewed publications, many of them based on RWE. As an active EMWA member, Maria runs a workshop: What medical writers need to know about patient registry.
Andrea Bucceri has spent over 10 years working in scientific research in a number of research institutes in Italy, The Netherlands and Switzerland, where he earned a PhD in Molecular Genetics at the ETH - Zurich. After a postdoctoral experience at Cancer Research UK in London, in 2007 he moved to Open Access Scientific Publishing. He then spent a few years working in Medical Communications for large and small pharmaceutical companies, where he managed diverse communication and medical writing accounts. In 2014, Andrea returned to Open Access Publishing as Publication Development Manager at Dove Medical Press (now part of Taylor & Francis Group, an Informa Business).
Thomas Wagner is a biologist by training and was working hard to unravel the mysteries of the brain. However, in order to avoid going mad himself, he quit university and started his medical writing career in 1999 with the CRO Kendle in Munich. In 2002 he changed to big pharma and worked for Lilly Deutschland GmbH, mainly writing on Phase III-IV projects, including non-interventional studies. He mostly tackled psychiatry, quality of life, and red tape in the position of Group Leader Scientific Communications Europe for Neurosciences at Eli Lilly & Co. He then changed in 2009 to the other side of the fence now working as a service provider and consultant for Trilogy Writing as Medical Writing Manager. Finally, in 2015 Thomas moved to the headquarters of Merck KGaA in Germany and is responsible for all regulatory medical writing documents from Phase I to post-marketing studies in the “beyond oncology” area.
Phillip Leventhal is a Principal Medical Writer at Evidera, where he specializes in publication writing. He has more than 15 years of experience as a medical writer, has written more than 100 peer-reviewed publications. Phil has been the Editor-in-Chief of Medical Writing and on EMWA’s Executive Committee since 2011, and he leads professional workshops and academic workshops on writing peer-reviewed publications throughout Europe and North America.
Jasminka Roth is the founder and director of The Tao of Excellence. A company that provides services for strategic quality management and smart process design that is located in Switzerland—a global leader in medical technology and a hub for innovation in the industry. Jasminka is passionate about developing integrative and holistic approaches to business challenges in quality management and strategy and enabling sustainable solutions at every stage. Her leadership in quality management and business excellence for a number of high-profile companies, such as Orchid Orthopedics and Johnson & Johnson, has given her the specialist insight that enables her to implement creative, innovative and lasting solutions. Her long-standing experience and expertise spans healthcare, pharmaceuticals and the medical devices industry, and she is actively interested in affecting change and strengthening Switzerland’s industrial standpoint in these sectors. Jasminka holds a MSc and BSc in biochemistry and biotechnology from ETH Zürich and has carried out research at the Insel Spital in Bern and at the University of Sydney, Australia.