{"id":8841,"date":"2021-05-19T08:40:21","date_gmt":"2021-05-19T08:40:21","guid":{"rendered":"https:\/\/thepublicationplan.com\/?p=8841"},"modified":"2021-05-21T09:03:36","modified_gmt":"2021-05-21T09:03:36","slug":"meeting-report-summary-of-session-2-of-the-9th-emwa-symposium","status":"publish","type":"post","link":"https:\/\/thepublicationplan.com\/2021\/05\/19\/meeting-report-summary-of-session-2-of-the-9th-emwa-symposium\/","title":{"rendered":"Meeting report: summary of session 2 of the 9th EMWA symposium"},"content":{"rendered":"

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The 9th<\/sup> European Medical Writers Association (EMWA<\/a>) symposium, entitled \u2018Clinical Trials \u2013 New Trends<\/em>\u2019 took place on 6 May. The symposium explored the latest trends in the design, conduct and reporting of clinical trials over 3 sessions, focusing on insights relevant to medical writers and communicators.<\/p>\n

A summary of session 2 of the symposium is provided below to benefit those who were unable to attend, and as a timely reminder of the key topics for those who did.<\/p>\n

You can also read our summaries of session 1<\/a> and session 3<\/a>.<\/strong><\/em><\/p>\n

Session 2: News in analysing, publishing and presenting clinical trial data<\/h3>\n

The second session of the symposium was moderated by Myriam Stieler (Biotronik). It reviewed recent news and innovations around clinical trial data analysis, publishing, and presentation.<\/p>\n

Estimands in clinical trials \u2013 ICH E9 addendum<\/strong><\/h5>\n

Samuel Copt (Biosensors International) opened the session with an overview of the recent addendum (R1) to the International Council on Harmonization (ICH) E9 guidance<\/a>. These guidelines set out the principles of statistical methodology for clinical trials and have been around for more than 20 years. The objective of the addendum<\/a> is to improve the planning, design, analysis and interpretation of clinical trials and has been implemented, or is in the process of being implemented, by regulatory authorities around the globe.<\/p>\n

As a trial progresses, intercurrent events such as treatment discontinuation, administration of rescue medication or terminal events can affect the interpretation or outcome associated with the study objective. Copt explained that the addendum provides a framework to construct and define an \u2018estimand\u2019 or target of estimation, which specifies how intercurrent events will be handled, and \u201censures alignment between trial objectives, design, protocol language, trial conduct and statistical analyses\u201d.<\/p>\n

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The addendum [to the ICH E9 guidance] provides a framework to construct and define an \u2018estimand\u2019 or target of estimation, which specifies how intercurrent events will be handled.<\/em><\/p>\n

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Copt went on to describe the 4 attributes used to create an estimand that, when considered together, should address many intercurrent events:<\/p>\n