title: The natural history of conducting and reporting clinical trials: interviews with trialists.
abstract: BACKGROUND
  To investigate the nature of the research process as a whole, factors that might influence the way in which research is carried out, and how researchers ultimately report their findings.
  
  
  METHODS
  Semi-structured qualitative telephone interviews with authors of trials, identified from two sources: trials published since 2002 included in Cochrane systematic reviews selected for the ORBIT project; and trial reports randomly sampled from 14,758 indexed on PubMed over the 12-month period from August 2007 to July 2008.
  
  
  RESULTS
  A total of 268 trials were identified for inclusion, 183 published since 2002 and included in the Cochrane systematic reviews selected for the ORBIT project and 85 randomly selected published trials indexed on PubMed. The response rate from researchers in the former group was 21% (38/183) and in the latter group was 25% (21/85). Overall, 59 trialists were interviewed from the two different sources. A number of major but related themes emerged regarding the conduct and reporting of trials: establishment of the research question; identification of outcome variables; use of and adherence to the study protocol; conduct of the research; reporting and publishing of findings. Our results reveal that, although a substantial proportion of trialists identify outcome variables based on their clinical experience and knowing experts in the field, there can be insufficient reference to previous research in the planning of a new trial. We have revealed problems with trial recruitment: not reaching the target sample size, over-estimation of recruitment potential and recruiting clinicians not being in equipoise. We found a wide variation in the completeness of protocols, in terms of detailing study rationale, outlining the proposed methods, trial organisation and ethical considerations.
  
  
  CONCLUSIONS
  Our results confirm that the conduct and reporting of some trials can be inadequate. Interviews with researchers identified aspects of clinical research that can be especially challenging: establishing appropriate and relevant outcome variables to measure, use of and adherence to the study protocol, recruiting of study participants and reporting and publishing the study findings. Our trialists considered the prestige and impact factors of academic journals to be the most important criteria for selecting those to which they would submit manuscripts.
authors.affiliation: School of Nursing, Midwifery and Social Work, University of Manchester, Manchester, M13 9PL, UK. rebecca.smyth@manchester.ac.uk.
authors.forename: Rebecca M D
authors.initials: RM
authors.lastname: Smyth
authors.affiliation: Division of Public Health, University of Liverpool, Liverpool, L69 3GB, UK. ajacoby@liverpool.ac.uk.
authors.forename: Ann
authors.initials: A
authors.lastname: Jacoby
authors.affiliation: Centre for Statistics in Medicine, University of Oxford, Oxford, OX2 6UD, UK. doug.altman@csm.ox.ac.uk.
authors.forename: Douglas G
authors.initials: DG
authors.lastname: Altman
authors.affiliation: Centre for Medical Statistics and Health Evaluation, University of Liverpool, Liverpool, L69 3GS, UK. C.Gamble@liverpool.ac.uk.
authors.forename: Carrol
authors.initials: C
authors.lastname: Gamble
authors.affiliation: Centre for Medical Statistics and Health Evaluation, University of Liverpool, Liverpool, L69 3GS, UK. P.R.Williamson@liverpool.ac.uk.
authors.forename: Paula R
authors.initials: PR
authors.lastname: Williamson
mesh_terms: D002985:Clinical Protocols; D002986:Clinical Trials as Topic; D006801:Humans; D007407:Interviews as Topic; D010506:Periodicals as Topic; D012107:Research Design