Guidance
Guidelines for the Content of Statistical Analysis Plans in Clinical Trials – 2017 [JAMA. 2017;318(23):2337-2343.doi:10.1001/jama.2017.18556.]
Early phase clinical trials extension to guidelines for the content of statistical analysis plans [BMJ 2022; 376 doi: https://doi.org/10.1136/bmj-2021-068177 (Published 07 February 2022)]
Considerations for a Participant Data Sharing SOP [March 2021]
Reports & Publications
e-Consent in UK academic-led clinical trials: current practice, challenges and the need for more evidenceTrials24, 657 (2023). https://doi.org/10.1186/s13063-023-07656-8 [October 2023] – As part of the e-Consent collaborative group
Editorial – Guidelines for Statistical Analysis Plans – 2017 [JAMA. 2017;318(23):2301-2303. doi:10.1001/jama.2017.18954.]
Trial Steering Committees in randomised controlled trials: A survey of registered clinical trials units to establish current practice and experiences – 2015 [Clin Trials. 2015 Dec;12(6):664-76. doi: 10.1177/1740774515589959.]
Training
Good Statistical Practice – Tailored GCP Training for Statisticians
~ Module 1 – Core Good Clinical Practice training
~Module 2 – Record keeping and documentation
~Module 3 – Trial design, randomisation and blinding
~Module 4 – Data Management
~Module 5 – Statistical analysis and reporting
Other Resources
Trials Methodology Podcast [2024 – 2025]
Find out more about the “Who”, “What”, “When”, “Why” and “How” of trials methodology in this series by Ella Howes and Georgiana Synesi.
In each episode, Ella and Georgiana talk to a different professional working in the field, as well as asking other TMRP-DTP students about their projects, and life as PhD students.
Listen wherever you get your podcasts: https://linktr.ee/trialsmethodologypodcast
This podcast was funded and produced by the MRC-NIHR Trials Methodology Research Partnership (TMRP) Doctoral Training Partnership (DTP).
Collaborate
UKCRC Registered CTU Network Search for Oversight Statistician Database [Made available December 2016]
~ To register or access the database please click here.
Membership
For a list of current Statistic Operations Group members please click here.
