Introduction: Post-trial access (PTA) to investigational drugs for participants of clinical studies is a critical ethical, legal, and practical issue. It is widely viewed as a matter of justice and beneficence: participants who assume the risks and inconveniences of a trial, and who have benefited from the investigational treatment, should not be abandoned once the study concludes. Key Considerations for Principal Investigators (PIs): Expanded Access Schedule: Availability of an established mechanism to provide ongoing treatment. Socioeconomic Status: Assessment of participants’ ability to afford the treatment post-trial.
Facilitation Platforms: Development of a common platform to streamline benefits for participants. Data Security: Ensuring confidentiality and safety in handling participant information. Conclusion: These issues deserve deeper deliberation at industry–academic forums,…
