Clinical Trials in Pancreatitis: Opportunities and Challenges in the Design and Conduct of Patient-Focused Clinical Trials in Recurrent Acute and Chronic Pancreatitis: Summary of a National Institute of Diabetes and Digestive and Kidney Diseases Workshop.

Abstract: Recurrent acute pancreatitis and chronic pancreatitis represent high morbidity diseases, which are frequently associated with chronic abdominal pain, pancreatic insufficiencies, and reduced quality of life. Currently, there are no therapies to reverse or delay disease progression, and clinical trials are needed to investigate potential interventions that would address this important gap. This conference report provides details regarding information shared during a National Institute of Diabetes and Digestive and Kidney Diseases-sponsored workshop on Clinical Trials in Pancreatitis that sought to clearly delineate the current gaps and opportunities related to the design and conduct of patient-focused trials in recurrent acute pancreatitis and chronic pancreatitis. Key stakeholders including representatives from patient advocacy organizations, physician investigators (including clinical trialists), the US Food and Drug Administration, and the National Institutes of Health convened to discuss challenges and opportunities with particular emphasis on lessons learned from trials in participants with other painful conditions, as well as the value of incorporating the patient perspective throughout all stages of trials.
Competing Interests: The following authors disclose potential conflicts of interest: P.A.H. (honoraria for consulting from Kangen Pharmaceuticals and Sagent Pharmaceuticals paid to his institution; honorarium for advisory board from Horizon Therapeutics USA, Inc, paid to his institution); G.A.C. (honoraria for consulting from Olympus Corporation of the Americas); I.G. (honoraria from Adynxx, Biogen, Eupraxia, Novaremed and GW Research); R.H.D. (past 5 years, research grants and contracts from the US Food and Drug Administration and the US National Institutes of Health and compensation forf serving on advisory boards or consulting on clinical trial methods from Abide, Acadia, Adynxx, Analgesic Solutions, Aptinyx, Aquinox, Asahi Kasei, Astellas, Beckley, Biogen, Biohaven, Biosplice, Boston Scientific, Braeburn, Cardialen, Celgene, Centrexion, Chiesi, Chromocell, Clexio, Collegium, Concert, Confo, Decibel, Editas, Eli Lilly, Endo, Ethismos (equity), Eupraxia, Exicure, Glenmark, Gloriana, Grace, Hope, Lotus, Mainstay, Merck, Mind Medicine (also equity), Neumentum, Neurana, NeuroBo, Novaremed, Novartis, OCT, OliPass, Pfizer, Q-State, Reckitt Benckiser, Regenacy (also equity), Sangamo, Sanifit, Scilex, Semnur, SIMR Biotech, Sinfonia, SK Biopharmaceuticals, Sollis, SPRIM, Teva, Theranexus, Toray, Vertex, Vizuri, and WCG); C.E.F. (research funding from Abbvie, consulting fees from Nestlé, and board member for National Pancreas Foundation); J.A.R. (consulting for Pediatrics Steering Committee, Pacira Pharmaceuticals); and D.C.W. (cofounder and chief scientific offer of Ariel Precision Medicine, consultant to Nestlé, Regeneron, and Ariel Precision Medicine). The rest of the authors declare no conflict of interest.
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