Gulf War Illness Clinical Trials and Interventions Consortium (GWICTIC): A collaborative research infrastructure for intervention and implementation.

Author(s)

Amanpreet K Cheema, Nova Southeastern UniversityFollow
Rebecca B McNeil, RTI International, Research Triangle Park, NC, United States
Travis Craddock, Nova Southeastern UniversityFollow
Gordon Broderick, Nova Southeastern UniversityFollow
Maria Abreu, Nova Southeastern UniversityFollow
Kristina Aenlle, Nova Southeastern UniversityFollow
Drew A Helmer, Center for Innovations in Quality, Effectiveness and Safety, Michael E. DeBakey VA Medical Center, Houston, TX, United States
J Wesson Ashford, War Related Illness & Injury Study Center, VA Palo Alto Health Care System, Palo Alto, CA, United States
Kimberly Sullivan, Department of Environmental Health, Boston University School of Public Health, Boston, MA, United States
Alison Bested, Nova Southeastern UniversityFollow
Devra Cohen, Nova Southeastern UniversityFollow
Dikoma Shungu, Department of Radiology, Weill Cornell Medical College, New York, NY, United States
Helena Chandler, War Related Illness and Injury Study Center, Department of Veterans Affairs New Jersey Health Care System, East Orange, NJ, United States
Mary Ann Fletcher, Nova Southeastern University
Maxine Krengel, VA Boston Healthcare System, Boston, MA, United States
Nancy Klimas, Nova Southeastern UniversityFollow

Document Type

Article

Publication Title

Life Sciences

ISSN

1879-0631

Publication Date

8-1-2021

Abstract

AIMS: There is an inadequate portfolio of treatments for Gulf War Illness (GWI), a complex disease involving multiple organ systems, and early-phase clinical trials are hampered by many logistical problems. To address these challenges, the Gulf War Illness Clinical Trials and Interventions Consortium (GWICTIC) was formed with the aims of (i) creating a collaborative consortium of clinical and scientific researchers that will rapidly implement rigorous and innovative phase I and II clinical trials for GWI, (ii) perform at least four phase I or II clinical trials, (iii) provide a foundation of scalable infrastructure and management in support of the efficient and successful operation of the GWICTIC, and (iv) partner with the Boston Biorepository, Recruitment & Integrated Network for GWI and other GWI investigators to develop a common data element platform for core assessments and outcomes.

MAIN METHODS: The GWICTIC brings together a multidisciplinary team of researchers at several institutions to provide scientific innovation, statistical and computational rigor, and logistical efficiency in the development and implementation of early-phase low-risk clinical trials for GWI. The GWICTIC core trials adhere to a Veteran-centered philosophy and focus on interventions with multiple mechanistic targets to maximize the likelihood of efficacy. To support rapid and efficient study startup and implementation across the GWI research community, the GWICTIC will share infrastructure with investigator-initiated research studies funded under separate mechanisms.

SIGNIFICANCE: The GWICTIC will leverage the efficiencies of centralized research support and innovative trial designs to address several longstanding needs in the GWI interventions research community.

DOI

10.1016/j.lfs.2021.119636

Volume

278

First Page

119636

Last Page

119636

PubMed ID

34015289

NSUWorks Citation

Cheema, A., McNeil, R., Craddock, T., Broderick, G., Abreu, M., Aenlle, K., Helmer, D., Ashford, J., Sullivan, K., Bested, A., Cohen, D., Shungu, D., Chandler, H., Fletcher, M., Krengel, M., Klimas, N. (2021). Gulf War Illness Clinical Trials and Interventions Consortium (GWICTIC): A collaborative research infrastructure for intervention and implementation.. Life Sciences, 278, 119636-119636.
Available at: https://nsuworks.nova.edu/cps_facarticles/1943