Updated 08 September 2026
Further to the work already being done (outlined below), we are proud to now open a dialogue with regulators in South Korea (click the image to read the full letter). We will keep you posted.

14 August 2026

The ongoing campaign to ask regulators to refrain from using 20^th century solutions to 21^st century questions continues.  On this page, you can see we have been campaigning in a number of ways to highlight to regulatory bodies that placebo arms in confirmatory trials are no longer attainable.

In order to step up the campaign, 23 patient organisations have come together to ask the regulatory bodies that we are not only part of the conversation but part of the solution.  Since the inaugural International PBC Summit of 2023, this has been a recurring topic of conversation which continues to be unaddressed.   This letter is not the first step nor is it the last but it highlights the depth of feeling and the level of seriousness with which we are working together to find a resolution.

The 23 patient organisation have worked tirelessly since the first Summit to represent patients’ concerns and the risks to their safety.  Our pledge is that we will continue to do this in a series of escalations until patient safety is no longer compromised by confirmatory trials.  Each of the groups involved will be working in our own ways but we stand together resolute.   That we are arguing for the right thing for patients is incontestable and it’s a matter of time until the necessary changes are made.

We thank clinicians and our industry partners for their support in this campaign and the recognition of the need for modernisation of clinical trial structures and regulatory processes.  Please see the letter below.  If you wish to forward it on the any of the relevant bodies, we would be grateful.

*Maya Angelou