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Implementing post-trial access plans for HIV prevention research.

Amy Paul1, Maria W Merritt1,2, Jeremy Sugarman1,3

  • 1Berman Institute of Bioethics, Johns Hopkins University, Baltimore, Maryland, USA.

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|March 1, 2018
PubMed
Summary
This summary is machine-generated.

Ensuring post-trial access (PTA) to beneficial interventions requires addressing practical implementation challenges. Simply referring participants to healthcare systems is insufficient for continued access to HIV prevention trial medications.

Keywords:
HIV infection and AIDSclinical trialsresearch ethics

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Area of Science:

  • Public Health
  • Clinical Trials
  • Medical Ethics

Background:

  • Ethical guidelines emphasize researcher and sponsor obligations for post-trial access (PTA) to beneficial interventions.
  • Limited practical information exists on the implementation of PTA plans, hindering optimization and conceptual development.

Purpose of the Study:

  • To explore the practical experiences and challenges in developing and implementing PTA plans.
  • To inform strategies for improving PTA implementation in clinical research.

Main Methods:

  • The study draws on experiences from developing and implementing PTA plans for six large-scale, multicenter HIV prevention trials.
  • Analysis focuses on challenges encountered during planning and implementation phases.

Main Results:

  • Planning PTA involves significant uncertainty and practical barriers within healthcare systems.
  • Even with approved interventions, system-level obstacles can impede PTA viability.
  • Referral to local healthcare systems alone does not guarantee continued access for trial participants.

Conclusions:

  • Successful PTA requires proactive efforts beyond simple referrals, including learning from future approaches.
  • Measuring PTA success through dedicated follow-up is crucial.
  • Developing normative guidance is necessary to navigate practical PTA challenges for research stakeholders.