The Double-edged Sword: Balancing Post-trial Drug Ethical Considerations and Participant Safety—A Narrative Review
Year: 2025
Type: review
Abstract: Aim and background: This narrative review aims to provide a comprehensive overview of the background and ethical dimensions of post-trial drug access, to explore the intricate balance between drug benefits, side effects, and burden, and to identify strategies for navigating this ethical labyrinth while upholding principles of beneficence, autonomy, and justice.Methods: A comprehensive literature search was conducted using PubMed, Scopus, Google Scholar, pharmaceutical databases, to identify literature published between 1994 and 2024.Keywords such as "clinical trial," "post-trial drug access," "participant safety," "regulatory framework," and "risk management" were used to retrieve peer-reviewed articles, meta-analyses, original research data.Relevant data from various welfare associations and pharmaceutical company were reviewed alongside review of clinical and clinical trial data.Results: Regulatory frameworks emphasize the ethical imperative of post-trial care as but translating principles into practice entails navigating logistical and financial complexities.Recent HIV prevention research highlights the ethical nuances surrounding post-trial drug access, underscoring the need for comprehensive prevention services.Robust risk management strategies are essential, alongside transparent reporting of adverse events and collaboration among stakeholders.Real-world case studies provide insights into balancing ethics with participant safety, offering opportunities for ethical reflection and consensus-building.Moving forward, continued research is needed to optimize post-trial access programs and address healthcare disparities.Conclusion: By fostering dialogue and collaboration, we can create an ethical framework for post-trial drug access that advances medical science while ensuring participant well-being.Clinical significance: Proactive monitoring ensures participant safety post-trial.It also facilitates management of chronic side effects alongside ensuring continuity of care.Post-trial drug access acts as a mode of distributive justice unless constraints to the research along with the question for fair distribution to community arise, which leads to the need for addressing such ethical dilemma.
Language: English
Topic: Ethics in Clinical Research
Field: Medicine
Domain: Health Sciences
Open Access status: gold
OpenAlex ID: W4411570730