TY - JOUR
T1 - The Myositis Clinical Trials Consortium
T2 - an international collaborative initiative to promote clinical trials in adult and juvenile myositis
AU - Bishnoi, Anuradha
AU - Tang, Iris Yan Ki
AU - Yoshida, Akira
AU - Pais, Faye M.
AU - Usman, Sabeena Y.
AU - Dominguez, Solciris
AU - Kavadichanda, Chengappa G.
AU - Rivero-Gallegos, Daphne
AU - Dourado, Eduardo
AU - Conticini, Edoardo
AU - Bozán, Francisca
AU - Tulluru, Gayathri
AU - Lilleker, James B.
AU - Reddy, Kaushik Sreerama
AU - Landon-Cardinal, Océane
AU - Smaili, Rachid
AU - Keret, Shiri
AU - Khoo, Thomas
AU - Lan, Ting-Yuan
AU - Leclair, Valérie
AU - Oddis, Chester V.
AU - Vencovský, Jiří
AU - Kuwana, Masataka
AU - Gandiga, Prateek C.
AU - Aggarwal, Rohit
AU - Myositis Clinical Trials Consortium investigators
AU - Benveniste, Olivier
AU - Brito de Araujo, Daniel
AU - Charles-Schoeman, Christina
AU - Chinoy, Hector
AU - Corte, Tamera J.
AU - Dimachkie, Mazen M.
AU - Dodiuk-Gad, Roni P.
AU - Eichenbrenner, Paula
AU - Fujimoto, Manabu
AU - García-de la Torre, Ignacio
AU - Govind, Nimmisha
AU - Goyal, Namita A.
AU - Griger, Zoltan
AU - Hallowell, Robert W.
AU - Hudson, Marie
AU - Limaye, Vidya
AU - Rajasekhar, Liza
AU - Lubinus, Manuel
AU - Lundberg, Ingrid E.
AU - Malloy, Shannon
AU - Marder, Galina
AU - Metni, Layla
AU - Myles, Jane
AU - Needham, Merrilee
AU - Raaphorst, Joost
AU - Rider, Lisa G.
AU - Rojas-Serrano, Jorge
AU - Schmidt, Jens
AU - Selva-O’Callaghan, Albert
AU - Shinjo, Samuel Katsuyuki
AU - Shobha, Vineeta
AU - So, Ho
AU - Ventura, Iazsmin Bauer
AU - Venuturupalli, Swamy
AU - Vleugels, Ruth Ann
AU - Wang, Guochun
AU - Wang, Qian
AU - Wilfong, Erin M.
AU - Feldman, Brian M.
AU - Huber, Adam M.
AU - Kim, Hanna
AU - Kim, Susan
AU - Ravelli, Angelo
AU - van Royen-Kerkhof, Annet
N1 - Publisher Copyright:
© Copyright CLINICAL AND EXPERIMENTAL RHEUMATOLOGY 2025.
PY - 2025/2/1
Y1 - 2025/2/1
N2 - Idiopathic inflammatory myopathies (IIM), or myositis, are a heterogeneous group of systemic autoimmune disorders that are associated with significant morbidity and mortality. Conducting high-quality clinical trials in IIM is challenging due to the rare and variable presentations of disease. To address this challenge, the Myositis Clinical Trials Consortium (MCTC) was formed. MCTC is a collaborative international alliance dedicated to facilitating, promoting, coordinating and conducting clinical trials and related research in IIM. This partnership works to advance the discovery of effective evidence-based treatments for IIM by integrating a diverse group of clinical investigators, research professionals, medical centres, patient groups, and industry partners. The Steering Committee, Core Group, and Paediatric Subcommittee of MCTC are comprised of myositis experts and junior investigators from around the world, representing a diversity of genders, geographies, and subspecialties. MCTC works alongside other current myositis organisations to complement existing work by concentrating on the operationalisation of clinical trials. Our pilot Myositis Investigators’ Information Survey gathered responses from 173 myositis investigators globally and found considerable variability in proficiency with outcome measures, geographic disparities in patient recruitment, and a significant disconnect between investigators’ routine myositis patient load and clinical trial enrolment. MCTC will meet the need to support and diversify myositis clinical trials by facilitating trial planning, feasibility assessments, site selection, and the training and mentoring of junior investigators/centres to establish their readiness for clinical trial participation. Through experienced leadership, strategic collaborations, and interdisciplinary discussions, MCTC will establish standards for IIM clinical trial design, protocols, and outcome measures in myositis.
AB - Idiopathic inflammatory myopathies (IIM), or myositis, are a heterogeneous group of systemic autoimmune disorders that are associated with significant morbidity and mortality. Conducting high-quality clinical trials in IIM is challenging due to the rare and variable presentations of disease. To address this challenge, the Myositis Clinical Trials Consortium (MCTC) was formed. MCTC is a collaborative international alliance dedicated to facilitating, promoting, coordinating and conducting clinical trials and related research in IIM. This partnership works to advance the discovery of effective evidence-based treatments for IIM by integrating a diverse group of clinical investigators, research professionals, medical centres, patient groups, and industry partners. The Steering Committee, Core Group, and Paediatric Subcommittee of MCTC are comprised of myositis experts and junior investigators from around the world, representing a diversity of genders, geographies, and subspecialties. MCTC works alongside other current myositis organisations to complement existing work by concentrating on the operationalisation of clinical trials. Our pilot Myositis Investigators’ Information Survey gathered responses from 173 myositis investigators globally and found considerable variability in proficiency with outcome measures, geographic disparities in patient recruitment, and a significant disconnect between investigators’ routine myositis patient load and clinical trial enrolment. MCTC will meet the need to support and diversify myositis clinical trials by facilitating trial planning, feasibility assessments, site selection, and the training and mentoring of junior investigators/centres to establish their readiness for clinical trial participation. Through experienced leadership, strategic collaborations, and interdisciplinary discussions, MCTC will establish standards for IIM clinical trial design, protocols, and outcome measures in myositis.
KW - clinical trials
KW - myositis
KW - organisation and administration
KW - outcome assessment
KW - rare diseases
UR - https://www.scopus.com/pages/publications/86000149599
U2 - 10.55563/clinexprheumatol/k7665a
DO - 10.55563/clinexprheumatol/k7665a
M3 - Article
C2 - 39977016
SN - 0392-856X
VL - 43
SP - 202
EP - 210
JO - Clinical and experimental rheumatology
JF - Clinical and experimental rheumatology
IS - 2
ER -