title: Do I have enough time? The impact of recruiting patients to a randomised controlled trial at recruiting centres.
abstract: BACKGROUND
  This paper explores the impact of recruiting patients to a randomised controlled trial (RCT) at recruiting centres. This large multicentre RCT examining the efficacy of chewing gum compared to ibuprofen in the relief of orthodontic pain was carried out across nine recruiting centres.
  
  
  METHODS
  The work diaries of clinicians and supporting staff at recruiting centres were analysed over a four-month period from September to December 2011. This quantified the amount of clinical and non-clinical time spent on research duties.
  
  
  RESULTS
  Over this time period 98 patients were recruited across seven trial sites. On average, patient recruitment had a direct clinical impact of 19 minutes per patient recruited. The time commitment on trial administration outside the clinical sessions was much higher, averaging at 110 minutes per patient recruited, giving the overall time spent on the trial 129 minutes per patient.
  
  
  CONCLUSIONS
  This information will be valuable to lead researchers when calculating the full economic cost of a proposed clinical trial and therefore when applying for grant funding. It may also be valuable to clinicians and their managers when considering becoming a principle investigator (PI) in a RCT. Although the impact on clinical time was 19 minutes per patient recruited, there is a considerably higher (almost six times greater) time commitment in administration around the recruitment of patients.
authors.affiliation: Dorset County Hospital, Bristol. Pamela.Ellis@dchft.nhs.uk
authors.forename: P E
authors.initials: PE
authors.lastname: Ellis
authors.forename: R L
authors.initials: RL
authors.lastname: Bradley
authors.forename: J R
authors.initials: JR
authors.lastname: Sandy
authors.forename: S A
authors.initials: SA
authors.lastname: Deacon
authors.forename: H S
authors.initials: HS
authors.lastname: Griffiths
authors.forename: N E
authors.initials: NE
authors.lastname: Atack
authors.forename: M B
authors.initials: MB
authors.lastname: Moore
authors.forename: K A
authors.initials: KA
authors.lastname: House
authors.forename: N A
authors.initials: NA
authors.lastname: Wenger
authors.forename: V
authors.initials: V
authors.lastname: Worth
authors.forename: A J
authors.initials: AJ
authors.lastname: Ireland
mesh_terms: D003362:Cost-Benefit Analysis; D004739:England; D062306:Geography, Medical; D006801:Humans; D018579:Patient Selection; D016032:Randomized Controlled Trials as Topic / Q000191:economics* / Q000379:methods / Q000706:statistics & numerical data; D012107:Research Design; D011795:Surveys and Questionnaires; D016526:Workload / Q000706:statistics & numerical data*