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Dr. Joan Genescà and Dr. Jose Luís Calleja
The aim of this session was to highlight the needs and perspectives from the point of view of different areas involved in clinical trials: research, regulatory bodies and the pharmaceutical industry.
Vall d'Hebron hosted last April 28th the first edition of the workshop on clinical trials in patients with non-alcoholic steatohepatitis (NASH) with compensated cirrhosis, organized by Dr. Joan Genescà, head of the Hepatology Department and clinical director at the Digestive Diseases area at Vall d'Hebron University Hospital, head of the Liver Diseases research group at Vall d'Hebron Research Institute (VHIR) and head of the Advanced Chronic Liver Disease research group at CIBERehd (ISCIII), and Juan Manuel Pericàs, member of the Liver Diseases research group and of the aforementioned CIBERehd group.
The aim of this session was to highlight the needs and perspectives of the different stakeholders involved in a clinical trial: research, regulatory bodies and the pharmaceutical industry. During the day, the regulatory environment and restrictions imposed by regulatory agencies, patient profiling and screening, and possible alternatives for clinical trial design were discussed.
An exceptional aspect of this workshop was to have the participation of national and international experts from the different fields involved in this type of trials from the academic world and the pharmaceutical industry, which resulted in very productive and comprehensive discussions. "The value of this workshop is to bring together experts from different specialties (portal hypertension and cirrhosis, NASH, pharmaceutical industry and regulators) in the same space, which are essential elements when designing a clinical trial", explained Dr. Joan Genescà during the opening of the event.
This first event served to initiate a debate on the challenges faced by researchers in conducting these trials, which we hope can potentially contribute to new discussions and initiatives to advance the field.
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