How to improve the implementation of academic clinical pediatric trials involving drug therapy? A qualitative study of multiple stakeholders

PLoS One. 2013 May 28;8(5):e64516. doi: 10.1371/journal.pone.0064516. Print 2013.

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.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Child
  • Clinical Trials as Topic*
  • Drug Therapy*
  • Female
  • Health Plan Implementation*
  • Hospitals*
  • Humans
  • Interviews as Topic
  • Male
  • Pediatrics*
  • Qualitative Research*

Grant support

This study was supported by a research grant from the Département de la Recherche Clinique et du Développement, AP-HP (RSR 08 002). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.