Statistical considerations in clinical trials: Asking better questions and the Estimand Framework

The Canadian Transfusion Trials Group (CTTG) is a pioneering national initiative designed to promote collaboration and excellence in Transfusion Medicine research. CTTG, led by co-directors Drs. Donald Arnold and Jeannie Callum, represents a paradigm shift in transfusion medicine research. CTTG supports the development of a cohesive and diverse transfusion medicine research community across Canada that can address high-impact research questions in Transfusion Medicine through a collaborative network of physician-investigators, blood scientists, graduate students, medical trainees and research staff across Canada. This research community will provide support for investigators for the development of trial protocols and grant submissions, centralized data management and biostatistics and mentorship for junior faculty.  CTTG will also support the creation of a multicentre “vein-to-vein” transfusion data platform to enable clinical trials, model demand forecasting, monitor changes in transfusion practice, and assess the impact of blood production modifications on patient outcomes.

Presented by

Dr. Robert Balshaw

Learning objectives

• Increase familiarity with the estimand framework [ICH E9(R1)]
• Appreciate intercurrent events and how they affect the design and analysis of clinical trials
• Obtain better answers from clinical trials by asking better questions

Dr. Balshaw has provided the following materials to review prior to his talk:

• Cro, S., & Phillips, R. (2024). All I want for Christmas is... a pecisely defined research question. Trials, 25(784), 1–5. https://doi.org/10.1097/00043860-199610000-00001
• Kahan, B. C., Hindley, J., Edwards, M., Cro, S., & Morris, T. P. (2024). The estimands framework: a primer on the ICH E9 (R1) addendum. British Medical Journal, 9(table 1), 1–12. https://doi.org/10.1136/bmj-2023-076316
• Guidance Document: ICH E9(R1) – https://www.ich.org/page/efficacy-guidelines#9-2

Registration 

Registration in advance is not required. The following Zoom access details may be used to join the live event:

https://us06web.zoom.us/j/88223965122?pwd=tePhmnT6jeCvl2p2LndMR7scqAbCjw.1 

Meeting ID: 882 2396 5122
Passcode:  693308