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Evidence-based guidelines for pediatric clinical trials: focus on StaR Child Health

Mario R Sampson1, Daniel K Benjamin, Michael Cohen-Wolkowiez

  • 1Duke Clinical Research Institute, Durham, 2400 Pratt Street, Durham, NC 27705, USA.

Expert Review of Clinical Pharmacology
|November 6, 2012
PubMed

Insights

Conducting clinical trials in children presents unique challenges. The Standards for Research (StaR) in Child Health initiative aims to improve pediatric trial design, conduct, and reporting through consensus guidelines.

Area of Science:

  • Pediatric clinical research
  • Regulatory science
  • Child health outcomes

Background:

  • Pediatric clinical trials face significant ethical and logistical hurdles, leading to common off-label prescribing with potential safety and efficacy issues.
  • Legislation in the US and Europe over the last 15 years has aimed to boost pediatric trial conduct through incentives and funding.
  • Despite progress, challenges in pediatric trial performance and a lack of standardized guidelines persist.

Purpose of the Study:

  • To address the persistent challenges in pediatric clinical trials.
  • To improve the design, conduct, and reporting of research involving children.
  • To establish and disseminate best practices for pediatric studies.

Main Methods:

  • The Standards for Research (StaR) in Child Health initiative was established in 2009.
  • Utilizes a consensus guideline approach involving diverse stakeholders (academia, government, industry).
  • Focuses on identifying and disseminating best practices for pediatric trials.

Main Results:

  • Six out of eleven planned standards have been published to date.
  • The StaR initiative has engaged multiple stakeholders to foster collaboration.
  • Progress has been made in developing standardized approaches for pediatric research.

Conclusions:

  • The StaR initiative represents a significant effort to standardize and improve pediatric clinical trials.
  • Continued development and implementation of these standards are crucial for enhancing child health research.
  • Addressing the knowledge gap and ethical considerations in pediatric trials remains an ongoing priority.

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