Clinical Trials in Pancreatitis: Opportunities and Challenges in the Design and Conduct of Patient-Focused Clinical Trials in Recurrent Acute and Chronic Pancreatitis
Year: 2022
Type: article
Abstract: 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.
Source: Pancreas
Authors: Phil A. Hart, Dana K. Andersen, Erica Lyons, Gregory A. Cote, Zobeida Cruz-Monserrate, Robert H. Dworkin, B. Joseph Elmunzer, Evan L. Fogel, Christopher E. Forsmark, Ian Gilron, Megan Golden, Aysegul Gozu, Lindsay McNair, Stephen J. Pandol, Emily R. Perito, Anna Evans Phillips, Jennifer A. Rabbitts, David C. Whitcomb, John A. Windsor, Dhiraj Yadav, Tonya M. Palermo
Institutions: The Ohio State University Wexner Medical Center, National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, United States Food and Drug Administration, Center for Drug Evaluation and Research, Oregon Health & Science University, University of Rochester Medicine, Neurology, Inc, University of Rochester, Medical University of South Carolina, Indiana University Indianapolis, University of Florida, Queen's University, Boston University, Cedars-Sinai Medical Center, University of California, San Francisco, UCSF Benioff Children's Hospital, University of Pittsburgh, University of Washington, Seattle Children's Research Institute, University of Pittsburgh Medical Center, University of Auckland
Language: English
Subfield: Surgery
Field: Medicine
Domain: Health Sciences
Open Access status: green
Awards: The Ohio State University Chronic Pancreatitis Diabetes Pancreas Cancer (CPDPC) Clinical Center, U-01 CONSORTIUM FOR THE STUDY OF CHRONIC PANCREATITIS,DIABETES AND PANCREATIC CANCER CLINICAL CENTERS, A Randomized Trial of a Web-based Non-Pharmacological Pain Intervention for Pediatric Chronic Pancreatitis, SpHincterotomy for Acute Recurrent Pancreatitis, UPMC Clinical Center for the Study of Diabetes after Acute Pancreatitis, UPMC Clinical Center for the Study of Chronic Pancreatitis and Diabetes, Epidemiology and Pathophysiology of Acute Pancreatitis-related Diabetes Mellitus, P-QST Project: Pancreatic Quantitative Sensory Testing (P-QST) to Predict Treatment Response for Pain in Chronic Pancreatitis, Indiana University (IU) Clinical Center for Chronic Pancreatitis Clinical Research Network, Continuation of Type 1 Diabetes in Acute Pancreatitis Consortium – UF Health and AdventHealth Combined Clinical Center, Indiana University clinical Center for acute pancreatitis and diabetes clinical research network
OpenAlex ID: W4309515420