The editors of a special issue of Journal of the Royal Statistical Society Series C (JRSS-C) focusing on early phase clinical trial design methodology, are inviting submissions.
The current landscape of drug development poses a challenge to widely accepted methods used in early phase clinical trials. Dose finding studies that aim to evaluate the safety of single agents are becoming less common, and advances in clinical research have complicated the paradigm of dose finding. More complex problems, such as those involving targeted agents and immunotherapies, combination therapies, different treatment schedules, and stratification of patients by clinical or genetic characteristics, have created the need to adapt early phase trial design to the specific agents being investigated, and the corresponding end points. Despite the emergence of novel statistical methods in the area, broad implementation of novel methods has been limited. There has been a call for wider use of more innovative methods to achieve the goals of contemporary research objectives. The aim of this special issue is to highlight recent developments in the field, as well as to emphasise implementation of novel designs in clinical trials.
Contributions to this special issue will include, but will not be limited to, suitable papers from presentations given at the 2nd Symposium on Early Phase Trial Design Methodology (http://mjb9cq.wixsite.com/symposium) to be held at the University of Virginia in Charlottesville, Virginia, April 26–28, 2017.
Papers submitted to this special issue should be within the remit of JRSS-C and will be subject to the usual standards of refereeing. Papers must be motivated by a specific practical example described in the paper, and should make a novel contribution to statistics by adapting or developing methodology, or by demonstrating the proper application of new or existing statistical methods. Papers describing routine applications of standard methods would not be suitable.
Manuscripts should be submitted through the journal’s on-line submission system https://mc.manuscriptcentral.com/jrss, clearly indicating that they are to be considered for the themed issue on ‘Early phase clinical trial design methodology'. The deadline for submission is August 31, 2017.
The editors of this special issue are: Nolan A Wages (co-guest editor), University of Virginia; Ying Yuan (co-guest editor), MD Anderson Cancer Center; and Nigel Stallard (JRSS-C editor), University of Warwick. They have committed to managing peer review 'carefully and in a timely manner', and continue: 'With your support and collaboration, we are confident that this special issue will make a serious impact on this very important area of statistics.'