RSS/PSI webinar: Estimands
Webinar held jointly with the PSI on the topical subject of ‘Estimands’
Estimands (what is to be estimated) is a new and hot topic in clinical development, in particular with the regulatory authorities who are responsible for approving new treatments. New regulatory guidance will be developed that will also address the subject of sensitivity analyses. This webinar will explore the current thinking on the topic and revisit some of the earlier work to consider how the topic has evolved over 10 years and how it might look in the future.
Chaired by Andy Garrett.
Featured PSI paper
Alan Philipps (et al.): ‘Estimands: discussion points from the PSI estimands and sensitivity expert group’, published online in Pharmaceutical Statistics.
Alan Phillips is vice president biostatistics, ICON Clinical Research, where he directs and manages the global biostatistics resource based in US, Europe and Asia Pacific. With over 25 years of experience in biostatistics, Dr Phillips has extensive knowledge of clinical trials, statistical methodology and world wide statistical regulatory requirements. He has published in areas including adaptive trial designs, regulatory statistical challenges (eg missing data, multiplicity) and statistical principles for clinical trials. In 2012, he was made an Honorary member of PSI in recognition of his scientific contributions to the organisation.
The topic of estimands is an important and relatively new one in clinical development. Estimands bridge the gap between study objectives and statistical methods. When defining estimands an iterative process linking trial objectives, estimands, trial design, statistical and sensitivity analysis needs to be established. Clinical trials are multi-faceted and expensive. Subsequently it is unrealistic to restrict a study to a single estimand. The set of estimands for a study will depend on the study objectives, the disease setting and the needs of the various stakeholders.
Featured RSS 'read paper':
Peter Diggle et al, ‘Analysis of longitudinal data with drop-out: objectives, assumptions and a proposal’. Published in JRSS-C, Vol. 56, Issue 5, November 2007.
Professor Diggle is the current president of the RSS. His biography is published on the RSS main website.
Professor Diggle will summarise key findings of his paper and show how ‘estimands’ has evolved over the last 10 years.
Webinar joining details
Further details on our journal webinars, including dial-in details, are on our main website page.
Sponsored by Quintiles and Wiley.
Organiser Name Judith Shorten
Organising Group(s) PSI and the Royal Statistical Society