title: Cross-sector surveys assessing perceptions of key stakeholders towards barriers, concerns and facilitators to the appropriate use of adaptive designs in confirmatory trials.
abstract: BACKGROUND
  Appropriately conducted adaptive designs (ADs) offer many potential advantages over conventional trials. They make better use of accruing data, potentially saving time, trial participants, and limited resources compared to conventional, fixed sample size designs. However, one can argue that ADs are not implemented as often as they should be, particularly in publicly funded confirmatory trials. This study explored barriers, concerns, and potential facilitators to the appropriate use of ADs in confirmatory trials among key stakeholders.
  
  
  METHODS
  We conducted three cross-sectional, online parallel surveys between November 2014 and January 2015. The surveys were based upon findings drawn from in-depth interviews of key research stakeholders, predominantly in the UK, and targeted Clinical Trials Units (CTUs), public funders, and private sector organisations. Response rates were as follows: 30(55 %) UK CTUs, 17(68 %) private sector, and 86(41 %) public funders. A Rating Scale Model was used to rank barriers and concerns in order of perceived importance for prioritisation.
  
  
  RESULTS
  Top-ranked barriers included the lack of bridge funding accessible to UK CTUs to support the design of ADs, limited practical implementation knowledge, preference for traditional mainstream designs, difficulties in marketing ADs to key stakeholders, time constraints to support ADs relative to competing priorities, lack of applied training, and insufficient access to case studies of undertaken ADs to facilitate practical learning and successful implementation. Associated practical complexities and inadequate data management infrastructure to support ADs were reported as more pronounced in the private sector. For funders of public research, the inadequate description of the rationale, scope, and decision-making criteria to guide the planned AD in grant proposals by researchers were all viewed as major obstacles.
  
  
  CONCLUSIONS
  There are still persistent and important perceptions of individual and organisational obstacles hampering the use of ADs in confirmatory trials research. Stakeholder perceptions about barriers are largely consistent across sectors, with a few exceptions that reflect differences in organisations' funding structures, experiences and characterisation of study interventions. Most barriers appear connected to a lack of practical implementation knowledge and applied training, and limited access to case studies to facilitate practical learning.
authors.affiliation: ScHARR, Regent Court, University of Sheffield, 30 Regent Street, S1 4DA, Sheffield, UK. m.dimairo@sheffield.ac.uk.
authors.forename: Munyaradzi
authors.initials: M
authors.lastname: Dimairo
authors.affiliation: ScHARR, Regent Court, University of Sheffield, 30 Regent Street, S1 4DA, Sheffield, UK. s.a.julious@sheffield.ac.uk.
authors.forename: Steven A
authors.initials: SA
authors.lastname: Julious
authors.affiliation: Department of Mathematics and Statistics, University of Reading, Whiteknights, Reading, RG6 6AX, UK. s.c.todd@reading.ac.uk.
authors.forename: Susan
authors.initials: S
authors.lastname: Todd
authors.affiliation: ScHARR, Regent Court, University of Sheffield, 30 Regent Street, S1 4DA, Sheffield, UK. j.nicholl@sheffield.ac.uk.
authors.forename: Jonathan P
authors.initials: JP
authors.lastname: Nicholl
authors.affiliation: ScHARR, Regent Court, University of Sheffield, 30 Regent Street, S1 4DA, Sheffield, UK. j.boote@herts.ac.uk.|Centre for Research in Primary and Community Care, University of Hertfordshire, Hatfield, AL109AB, Hertfordshire, UK. j.boote@herts.ac.uk.
authors.forename: Jonathan
authors.initials: J
authors.lastname: Boote
mesh_terms: D000329:Advertising; D001290:Attitude; D001291:Attitude of Health Personnel; D002983:Clinical Competence; D002986:Clinical Trials as Topic / Q000191:economics / Q000379:methods*; D003430:Cross-Sectional Studies; D006801:Humans; D020407:Internet; D010465:Perception; D017149:Private Sector; D017150:Public Sector; D012107:Research Design; D012108:Research Personnel / Q000523:psychology*; D012109:Research Support as Topic; D011795:Surveys and Questionnaires; D013997:Time Factors