title: How to improve the implementation of academic clinical pediatric trials involving drug therapy? A qualitative study of multiple stakeholders.
abstract: OBJECTIVE
  The need for encouraging pediatric drug research is widely recognized. However, hospital-based clinical trials of drug treatments are extremely time-consuming, and delays in trial implementation are common. The objective of this qualitative study was to collect information on the perceptions and experience of health professionals involved in hospital-based pediatric drug trials.
  
  
  METHODS
  Two independent researchers conducted in-depth semi-structured interviews with principal investigators (n = 17), pharmacists (n = 7), sponsor representatives (n = 4), and drug regulatory agency representatives (n = 3) who participated in institutionally sponsored clinical trials of experimental drugs in pediatric patients between 2002 and 2008.
  
  
  RESULTS
  Dissatisfaction was reported by 67% (16/24) of principal investigators and pharmacists: all 7 pharmacists felt they were involved too late in the trial implementation process, whereas 11 (65%) principal investigators complained of an excessive regulatory burden and felt they were insufficiently involved in the basic research questions. Both groups perceived clinical trial implementation as burdensome and time-consuming. The sponsor and regulatory agency representatives reported a number of difficulties but were not dissatisfied.
  
  
  CONCLUSIONS
  The heavy burden related to regulatory requirements, and suboptimal communication across disciplines involved, seem to be the main reasons for the major delays in pediatric drug trial implementation. The pharmaceutical aspects are intrinsically tied to trial methodology and implementation and must therefore be examined, in particular by involving Clinical Research Pharmacists at early stages of study conception.
authors.affiliation: Université Paris Diderot, Sorbonne Paris Cité, Paris, France. delphine.gd@gmail.com
authors.forename: Delphine
authors.initials: D
authors.lastname: Girard
authors.forename: Olivier
authors.initials: O
authors.lastname: Bourdon
authors.forename: Hendy
authors.initials: H
authors.lastname: Abdoul
authors.forename: Sonia
authors.initials: S
authors.lastname: Prot-Labarthe
authors.forename: Françoise
authors.initials: F
authors.lastname: Brion
authors.forename: Annick
authors.initials: A
authors.lastname: Tibi
authors.forename: Corinne
authors.initials: C
authors.lastname: Alberti
mesh_terms: D000328:Adult; D002648:Child; D002986:Clinical Trials as Topic; D004358:Drug Therapy; D005260:Female; D006284:Health Plan Implementation; D006761:Hospitals; D006801:Humans; D007407:Interviews as Topic; D008297:Male; D010372:Pediatrics; D036301:Qualitative Research