Gamble C, Wolf A, Sinha I, Spowart C, Williamson P. The role of systematic reviews in pharmacovigilance planning and Clinical Trials Authorisation application: example from the SLEEPS trial. PLoS ONE. 2013;8:e51787 pubmed publisher
..The Clinical Trials Authorisation was granted based on the data presented in the SmPC and the pharmacovigilance plan within the clinical trial protocol restricting collection and reporting to adverse reactions. ..
Jenkinson M, Javadpour M, Haylock B, Young B, Gillard H, Vinten J, et al. The ROAM/EORTC-1308 trial: Radiation versus Observation following surgical resection of Atypical Meningioma: study protocol for a randomised controlled trial. Trials. 2015;16:519 pubmed publisher
..The results of this study will be used to inform current neurosurgery and neuro-oncology practice worldwide. ISRCTN71502099 on 19 May 2014. ..
Gamble C, Nadel S, Snape D, McKay A, Hickey H, Williamson P, et al. What parents of children who have received emergency care think about deferring consent in randomised trials of emergency treatments: postal survey. PLoS ONE. 2012;7:e35982 pubmed publisher
..Distinction should be drawn between the views of bereaved and non-bereaved parents when considering the acceptability of different consent processes. ..