Post-trial access

The challenge of assuring continued post-trial access to beneficial treatment.

Reasons Why Post-Trial Access to Trial Drugs Should, or Need not be Ensured to Research Participants: A Systematic Review

Background: researchers and sponsors increasingly confront the issue of whether participants in a clinical trial should have post-trial access (PTA) to the trial drug. Legislation and guidelines are inconsistent, ambiguous or silent about many aspects of PTA. Recent research highlights the potential importance of systematic reviews (SRs) of reason-based literatures in informing decision-making ...

Post-trial access and the new version of the Declaration of Helsinki

In October 2013, the World Medical Association (WMA) approved the latest version of the Declaration of Helsinki (DoH) in Fortaleza, Brazil. Post-trial access of favorable interventions was again one of the critical issues raised during the meeting. The call to clinical research actors, other than physicians, in this discussion is not new, but this is the first time, after 49 years and nine amen...

Forthcoming practical framework for ethics committees and researchers on post-trial access to the trial intervention and healthcare.

When research concludes, post-trial access (PTA) to the trial intervention or standard healthcare can be crucial for participants who are ill such as those in resource-poor countries with inadequate healthcare, British participants testing ‘last-chance drugs’ unavailable on the National Health Service (NHS) and underinsured US participants. Yet, many researchers are unclear about their obligati...

Post-partum haemorrhage and the WOMAN trial.

Post-partum haemorrhage (PPH) is a leading cause of maternal mortality, accounting for about 100 000 maternal deaths every year. Almost all (99%) of the deaths are in low and middle income countries and most of the deaths occur in the immediate post-partum period. There are known effective treatments for preventing severe bleeding after childbirth and it is essential to ensure that all pregnant...