title: Review and publication of protocol submissions to Trials - what have we learned in 10 years?
abstract: Trials has 10 years of experience in providing open access publication of protocols for randomised controlled trials. In this editorial, the senior editors and editors-in-chief of Trials discuss editorial issues regarding managing trial protocol submissions, including the content and format of the protocol, timing of submission, approaches to tracking protocol amendments, and the purpose of peer reviewing a protocol submission. With the clarification and guidance provided, we hope we can make the process of publishing trial protocols more efficient and useful to trial investigators and readers.
authors.affiliation: Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, 615 North Wolfe Street, Room E6011, Baltimore, MD, 21205, USA. tli19@jhu.edu.
authors.forename: Tianjing
authors.initials: T
authors.lastname: Li
authors.affiliation: University Paris Descartes, Inserm Methods Team, CRESS-UMR 1153, Paris, France.|Centre d'épidémiologie Clinique, Hôpital Hôtel-Dieu, 1 place du Parvis Notre-Dame, Paris, 75004, France.
authors.forename: Isabelle
authors.initials: I
authors.lastname: Boutron
authors.affiliation: Centre for Clinical Brain Sciences, University of Edinburgh, Chancellor's Building, 49 Little France Crescent, Edinburgh, EH16 4SB, UK.
authors.forename: Rustam
authors.initials: R
authors.lastname: Al-Shahi Salman
authors.affiliation: Statistics and Operations Research Department, Barcelona Tech, Carrer de Jordi Girona 1, C5-213, 08034, Barcelona, Spain.
authors.forename: Erik
authors.initials: E
authors.lastname: Cobo
authors.affiliation: BioMed Central, 236 Gray's Inn Road, London, WC1X 8HB, UK.
authors.forename: Ella
authors.initials: E
authors.lastname: Flemyng
authors.affiliation: Ottawa Hospital Research Institute, The Ottawa Hospital - General Campus, 501 Smyth Road, Box 711, Ottawa, ON, K1H 8L6, Canada.
authors.forename: Jeremy M
authors.initials: JM
authors.lastname: Grimshaw
authors.affiliation: Centre for Statistics in Medicine, University of Oxford, Botnar Research Centre, Windmill Road, Oxford, OX3 7LD, UK.
authors.forename: Douglas G
authors.initials: DG
authors.lastname: Altman
mesh_terms: D035081:Editorial Policies; D006801:Humans; D010506:Periodicals as Topic; D011642:Publications; D011643:Publishing; D012107:Research Design