A rapid review of community engagement and informed consent processes for adaptive platform trials and alternative design trials for public health emergencies

by Alun Davies et al.
22nd April 2024 • comment

Development of an online resource for recruitment research in clinical trials to organise and map current literature

by Anna Kearney, Nicola Harman, Anna Rosala-Hallas, Claire Beecher, Jane Blazeby, Peter Bower, Mike Clarke, William Cragg, Sinead Dune, Heidi Gardner, Patricia Healy, Lisa Maguire, Nicola Mills, Leila Rooshenas, Ceri Rowlands, Shaun Treweek, Akke Vellinga, Paula Williamson, Carrol Gamble

Transparency in the conduct and reporting of clinical trials is supported by the guidance produced on the content of clinical trial protocols and reporting standards for clinical trials. While the principle features of the statistical analysis are required within this guidance it is generally accepted that a separate Statistical Analysis Plan is also developed as the level of detail appropriate for a SAP is excessive for a protocol. However, there is no detailed guidance on the content of a SAP and consequently, there is marked variation in practice. 

29th November 2018 • comment

Guidelines for the Content of Statistical Analysis Plans in Clinical Trials

by Carrol Gamble

Abstract Importance  While guidance on statistical principles for clinical trials exists, there is an absence of guidance covering the required content of statistical analysis plans (SAPs) to support transparency and reproducibility. Objective  To develop recommendations for a minimum set of items that should be addressed in SAPs for clinical trials, developed with input from statisticians, previous guideline authors, journal editors, regulators, and funders.

1st February 2018 • comment

Vulnerability and Exclusion from Research

by Mark P. Sheehan

Many of the scandals that surround modern medicine involve research conducted on human subjects. Consequently when discussion turns to the ethics of research, such atrocities as the Nazi hypothermia experiments at Dachau conentration camp during World War Two (Berger 1990) or the Tuskegee Syphilis Study in Alabama beginning in the 1930s (Pence 2000) are never far from the surface...The reaction to these atrocities has, justifiably, been extreme. In this paper, Sheehan considers the consequences of these reactions - the exclusion of particular groups from participation in research.

21st June 2011 • comment