Please save the date: March 15, 2018 from 11:00 am – 12:30 pm US EDT
Speakers:
Robert Hemmings, Unit Manager, Statistics and Pharmacokinetics Unit, Medicines and Healthcare products Regulatory Agency (MHRA), UK
Wolfgang Kothny, Clinical Development Medical Director, Novartis Pharma, Switzerland
Abstract:
This first webinar in a series of planned events discusses the steps to improve transparency and ensure alignment between trial objectives and statistical approaches in terms of clearly defining the treatment effect(s) targeted in a clinical trial.
This substantive evolution to traditional clinical trial design, conduct and analysis requires a multi-disciplinary effort and a common understanding beyond the statistics community. This first webinar in the series will refer to the draft addendum to the main statistical guidance in drug development – ICH E9 (link). It will provide a non-technical introduction and encompass clinical, statistical and regulatory perspectives. In addition, a structured framework to articulate precise measures of clinically meaningful endpoints will be presented.
Due to the importance and broad interest of this webinar, this webinar is being offered to all DIA Communities and the general public, at no cost to anyone who wishes to join the call. DIA is a not-for-profit organization. We, the leaders of partnering DIA Communities (Statistics, Patient Engagement, Regulatory Affairs, Study Endpoints, Clinical Research and Clinical Data Management communities, as well as the DIA/ASA Biopharma Safety Assessment WG) are grateful to DIA for this generosity and interest in advancing science, as we all consider how to design better trials via clear objectives and statistical plan.
The session promises to be an interesting and informative one. Please join* us!
* Regular events like this special, one-time open-to-all event, occur many months of the year as a free benefit to any DIA member who joins a DIA Community.
Registration (two-step process):
Part 1 – Enter information at the following link to receive a calendar invite and follow up email for Part 2: engage.diaglobal.org/DIA-Stats-Community-Webinar-1.html
Part 2 – Enter brief information to receive Zoom login and call in details.
