Trial update
The trial has been registered in a number of locations across the UK and will recruit participants who have been diagnosed with a brain tumour. The target sample sizes for each tumour group have been inflated to allow for the expected level of loss to follow-up and slower recruitment in early phases. Sample size calculations also assume that participants will remain on trial treatment for the full duration of the study and that all assessment visits will take place within a specified time frame. This is consistent with current clinical practice and will allow the trial team to monitor for any potential adverse events.
Detailed statistical analysis plans (SAPs) have been submitted for all cohorts. These are available to view as updates on the trial website. In addition, SAPs have been published in a paper in the Journal of the American Medical Association. This approach is recommended by the JAMA Editorial and is in line with the guidance on reporting of SAPs in clinical trials.
The asbestos inventory is assigned to Justice Manuel Mendez through Part 13. Justice Mendez has designated a number of Justices as Asbestos Trial Judges, including Justices Lucy Billings, Barbara Jaffe, Gerald Lebovits and Martin Shulman.