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In Silico Clinical Trials for Cardiovascular Disease
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Post-trial Access in Maternal Vaccine Trials.

I M A A Van Roessel1, N I Mazur1,2,3, S K Shah2,3

  • 1Division of Paediatric Immunology and Infectious Diseases, University Medical Centre Utrecht, Utrecht, The Netherlands.

American Journal of Perinatology
|June 26, 2019
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Summary
This summary is machine-generated.

Post-trial access (PTA) provisions are crucial for maternal vaccine trials, yet are poorly documented and understood. Ethical guidelines have not improved PTA application, highlighting a need for greater transparency and shared responsibility.

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Area of Science:

  • Clinical Ethics
  • Vaccinology
  • Public Health

Background:

  • Post-trial access (PTA) to experimental interventions is ethically mandated before clinical trial initiation.
  • While PTA is discussed in preventive vaccine research, it is often overlooked in maternal vaccine trials due to the unique considerations of pregnancy and infant health.
  • Formalized international ethical guidance on PTA has existed since 2000, yet its application in maternal vaccination research remains unclear.

Purpose of the Study:

  • To examine the application and adherence to post-trial access (PTA) provisions in maternal vaccine trials.
  • To compare PTA practices in publications before and after 2000, when international ethical guidelines were updated.
  • To assess principal investigators' awareness of PTA requirements in maternal vaccination research.

Main Methods:

  • Systematic review of randomized maternal vaccine trials (Phases II and III) published before and after 2000.
  • Analysis of trial publications for descriptions of PTA provisions, referencing World Medical Association's Declaration of Helsinki and CIOMS guidelines.
  • Questionnaire survey sent to principal investigators of identified trials to ascertain their knowledge and implementation of PTA.

Main Results:

  • No trial articles, either before or after 2000, described PTA provisions (0/7 and 0/17, respectively).
  • Over half of the contacted principal investigators were unfamiliar with international PTA recommendations.
  • PTA was primarily addressed by publishing trial results, and revisions to ethical guidelines in 2002 did not enhance PTA provisions in maternal vaccine trials.

Conclusions:

  • There is a significant gap in the documented application and understanding of post-trial access (PTA) in maternal vaccine trials.
  • Ethical guidelines and their revisions have not translated into improved PTA provisions for this specific population.
  • PTA is a shared responsibility; incorporating explicit PTA provisions into maternal vaccination trial protocols and publications is essential for transparency.