PSC Support Presents Patient Perspective to Regulatory and Research Authorities

Accelerating PSC research and raising the bar

PSC patient and Chair of Trustees of PSC Support, Martine Walmsley, presented patient views on research trials to those involved in their design and evaluation in March 2016, at an international conference hosted by the American Association for the Study of Liver Diseases (AASLD) and the US Food and Drug Administration (FDA) in Washington DC.

Researchers and regulatory authorities around the world, keen to incorporate realistic and justified patient views into their planning and delivery of studies, listened carefully.

Martine said: “This was a key meeting because it brought together leading researchers, patients, regulatory bodies and pharmaceutical companies to discuss current unmet needs and research in what is a complex, progressive disease, with no known cause or effective treatment.

“It is vital for patients that any novel treatment is licensed and made available for use as rapidly as possible, and that requires early collaboration with regulatory authorities like the FDA and EMA to ensure that trial design and endpoints meet the exacting standards required.

“This meeting was a golden opportunity for the PSC field to come together to begin to agree those standards.”