Partner Introduction (Clinical Trials Ontario): 5-min video.

• Summary: Susan Marlin (President & CEO, Clinical Trials Ontario) discusses Clinical Trials Ontario, a leading non-profit organization in the clinical trials community dedicated to strengthening, promoting, and capitalizing on Ontario’s competitive advantages for conducting high-quality clinical trials, and CanReview, a pan-Canadian collaboration supported by the ACT Canada Consortium to enable a single research ethics review for multi-site clinical trials conducted across Canada.

Value of the Statistical Analysis Plan for Medical & Scientific Research (June 5, 2017 via “UTAH Center for Clinical & Translational Science”): 10-min video.

• Summary: While not specific to clinical trials, this video provides an introductory overview of the value of statistical analysis plans in health research. Dr. Angela Presson describes what a statistical analysis plan is, at what stage of the research process it should be created, the high-level components of the plan, and follows through an example. The importance of mock-up tables and figures, as a tool to convey expectations between the research team lead(s) and the statistician(s), is emphasized. It is argued that statistical analysis plans are helpful tools for communicating analysis needs and expectations, that they should be developed prior to conducting the analysis, and they can serve to refine the research question and encourage hypothesis-driven research (vs. data fishing and unplanned post hoc analyses).

Ottawa Hospital Research Institute - Ottawa Methods Centre (OMC). Statistical Analysis Plan Template (2021): 6-page template.

• Summary: This statistical analysis plan template (for clinical trials) has been created by the Ottawa Methods Centre and draws on the recommendations presented in the guidelines by Gamble C, et al. JAMA. 2017 Dec 19;318(23):2337-2343. * An institutional login (e.g., university or research institute e-mail address) is required to access this material.

Collection of statistical analysis plans for pragmatic clinical trials: SURECAN trial (2025), PREOXI trial (2023), Aqueous-PREP trial (2022), PILOT trial (2021), PEP-TALK trial (2021)

• Summary: A non-exhaustive collection of published statistical analysis plans for pragmatic trials (ordered from newest to oldest). Related publications from the already-featured EnAKT LKD (2022) and MyTEMP (2021) exemplar trials are also available.

Kang M, et al. Incorporating estimands into clinical trial statistical analysis plans. Clin Trials. 2022 Jun;19(3):285-291. (10-page paper)

• Summary: As outlined in the “Estimands in clinical trials module” (Week of April 7, 2025), estimands ensure trials are addressing clinically relevant questions. This paper presents a table template to include in statistical analysis plans, which connects the estimand addressing a trial objective with how the associated statistical analysis will be conducted.

Gamble C, et al. Guidelines for the Content of Statistical Analysis Plans in Clinical Trials. JAMA. 2017 Dec 19;318(23):2337-2343. (7-page paper) * As this is an optional resource, an institutional login (e.g., university or research institute e-mail address) is required to access this material.

• Summary: Given that statistical analysis plans (along with trial registration and protocols) are important in ensuring appropriate reporting of clinical trials, recommendations - developed with input from statisticians, guideline authors, journal editors, regulators, and funders - are provided. These recommendations outline the minimum items that should be included in statistical analysis plans.

Australian Clinical Trials Alliance - Resources - Statistical Analysis Plan (SAP): 1-page website.

• Summary: Provides a template for a statistical analysis plan for a clinical trial as well as various examples of analysis plans, including an exemplar plan from a pragmatic trial.

International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH Harmonised Tripartite Guideline) - Statistical Principles for Clinical Trials E9 (Current Step 4 version, February 5, 1998): 39-page document.

• Summary: The role of statistics in clinical trial design and analysis has been acknowledged as essential since early iterations of the ICH guidelines. While this guidance is written primarily to attempt to harmonize the principles of statistical methodology applied to more traditional (explanatory) trials, many aspects remain applicable to trials that are more pragmatic in nature.

Hemming K, et al. Guidelines for the content of statistical analysis plans in clinical trials: protocol for an extension to cluster randomized trials. Trials. 2025 Feb 27;26(1):72. (14-page paper)

• Summary: While guidelines exist to inform the content of statistical analysis plans in clinical trials, this guidance is generally focused on trials with individual-level (vs. cluster-level) randomization. This protocol outlines the development of a set of reporting guidelines for analysis plans for cluster randomized trials, including variations such as the stepped-wedge cluster trial and other cluster cross-over designs.