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Enrollment of Neonates in More Than One Clinical Trial

Jonathan M Davis1, Gerri R Baer2, Ronald Portman3

  • 1Department of Pediatrics and the Tufts Clinical and Translational Science Institute, Tufts University, Boston, Massachusetts.

Clinical Therapeutics
|October 9, 2017
PubMed

Insights

Enrollment of very preterm neonates in multiple clinical trials is complex. This article examines scientific, ethical, and regulatory factors for concurrent study participation to improve infant outcomes.

Area of Science:

  • Neonatal research
  • Clinical trial ethics
  • Regulatory science

Background:

  • Very preterm neonates (<32 weeks' gestation) have high morbidity and mortality rates, necessitating novel therapies.
  • Legislative mandates in the US and Europe encourage research in this vulnerable population.
  • Small birth numbers and numerous trials create situations where neonates may qualify for multiple studies.

Purpose of the Study:

  • To examine the scientific, ethical, regulatory, and industry considerations for enrolling neonates in multiple clinical studies.
  • To provide guidance for neonatal units facing decisions about concurrent trial enrollment.

Main Methods:

  • Review of scientific principles relevant to multi-trial enrollment in neonates.
  • Analysis of ethical frameworks governing research with vulnerable populations.
  • Examination of regulatory guidelines and industry perspectives on multiple study participation.

Main Results:

  • Concurrent enrollment presents challenges related to scientific validity, ethical oversight, and regulatory compliance.
  • Balancing potential benefits against risks for individual neonates is crucial.
  • Standardized approaches and clear guidelines are needed to navigate these complex scenarios.

Conclusions:

  • Careful consideration of scientific, ethical, and regulatory factors is essential when enrolling neonates in multiple clinical trials.
  • Protecting the well-being of very preterm infants while advancing research is paramount.
  • Further development of best practices for multi-trial enrollment is warranted.

Keywords:
clinical trialco-enrollmentneonate

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