Dataset Information

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.

SUBMITTER: Girard D

PROVIDER: S-EPMC3665797 | biostudies-literature | 2013

REPOSITORIES: biostudies-literature

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Publications

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

Girard Delphine D Bourdon Olivier O Abdoul Hendy H Prot-Labarthe Sonia S Brion Françoise F Tibi Annick A Alberti Corinne C

PloS one 20130528 5

<h4>Objective</h4>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.<h4>Methods</h4>Two independent researchers conducted in-depth semi-structured interviews with princi ...[more]

PMID: 23724056

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Dataset Information

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

Objective

Methods

Results

Conclusions

Publications

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

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