TY - JOUR
T1 - Clinical Trials in Pancreatitis
T2 - 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
AU - Hart, Phil A.
AU - Andersen, Dana K.
AU - Lyons, Erica
AU - Cote, Gregory A.
AU - Cruz-Monserrate, Zobeida
AU - Dworkin, Robert H.
AU - Elmunzer, B. Joseph
AU - Fogel, Evan L.
AU - Forsmark, Christopher E.
AU - Gilron, Ian
AU - Golden, Megan
AU - Gozu, Aysegul
AU - McNair, Lindsay
AU - Pandol, Stephen J.
AU - Perito, Emily R.
AU - Phillips, Anna Evans
AU - Rabbitts, Jennifer A.
AU - Whitcomb, David C.
AU - Windsor, John A.
AU - Yadav, Dhiraj
AU - Palermo, Tonya M.
N1 - Publisher Copyright:
© Wolters Kluwer Health, Inc. All rights reserved.
PY - 2022/8/1
Y1 - 2022/8/1
N2 - 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.
AB - 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.
KW - chronic pancreatitis
KW - pain
KW - recurrent acute pancreatitis
KW - study design
UR - http://www.scopus.com/inward/record.url?scp=85142180503&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85142180503&partnerID=8YFLogxK
U2 - 10.1097/MPA.0000000000002105
DO - 10.1097/MPA.0000000000002105
M3 - Article
C2 - 36395394
AN - SCOPUS:85142180503
SN - 0885-3177
VL - 51
SP - 715
EP - 722
JO - Pancreas
JF - Pancreas
IS - 7
ER -