Development of an online resource for recruitment research in clinical trials to organise and map current literatureby 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.
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.
Understanding the investigators: a qualitative study investigating the barriers and enablers to the implementation of local investigator-initiated clinical trials in Ethiopiaby Sam Franzen
New BMJ Open article: “Understanding the investigators: a qualitative study investigating the barriers and enablers to the implementation of local investigator-initiated clinical trials in Ethiopia” This article was written by the research team at Global Health Trials in collaboration with researchers from Ethopia, Sri Lanka and Peru. The research was initiated in response to the low volume of clinical trials conducted by investigators in Low and Middle Income Countries.