title: An evaluation of the introduction of Clinical Trial Officer roles into the cancer clinical trial setting in the UK.
abstract: The National Cancer Research Network (NCRN) was created in 2001 to improve the infrastructure for cancer research within the National Health Service (NHS) in the UK and ensure that research is better integrated with cancer care. The NCRN consists of 34 regional networks which map onto the 34 cancer networks that were established following the publication of the NHS Cancer Plan with its aim of improving the coordination and delivery of cancer care and treatment nationally. An objective of the NCRN is to increase recruitment into cancer trials through improved support. One cancer research network responded by introducing Clinical Trial Officers (CTOs) into the cancer clinical trial setting in order to combine the range of tasks required to support clinical trials into a single role with the ultimate aim of increasing recruitment into cancer clinical trials. Evaluation during the first 14 months of their introduction assessed the impact of the new CTO role on cancer trial recruitment, its acceptability to those involved in trials and its effectiveness in achieving increased recruitment. Evaluation identified appropriate induction and training programmes required to support these new roles and the identification of a model for the introduction of CTO posts in other networks across the country. The findings presented in this paper identify that CTO roles can effectively be introduced into a cancer network and have an impact on recruitment to clinical trials within that network. The data collected provided an in-depth insight into how these roles were perceived, have developed and what supporting structures need to be in place to enable them to flourish. Recruitment in the network has increased and there has been a raising of awareness of clinical trials and cancer research across the whole of the cancer network where the CTOs were based. We conclude that CTO roles can offer a creative alternative to staffing cancer clinical trial units and that such a model could be introduced across other networks. Similar models could also be introduced into other disease settings where clinical research is taking place.
authors.affiliation: School of Nursing, Faculty of Medicine and Health Sciences, University of Nottingham, Nottingham, UK. karen.cox@nottingham.ac.uk
authors.forename: K
authors.initials: K
authors.lastname: Cox
authors.forename: M
authors.initials: M
authors.lastname: Avis
authors.forename: E
authors.initials: E
authors.lastname: Wilson
authors.forename: R
authors.initials: R
authors.lastname: Elkan
mesh_terms: D000288:Administrative Personnel; D002322:Career Mobility; D002986:Clinical Trials as Topic; D005260:Female; D006801:Humans; D008297:Male; D009369:Neoplasms; D018579:Patient Selection; D012107:Research Design; D013222:State Medicine; D006113:United Kingdom