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

Amanpreet K Cheema; Rebecca B McNeil; Travis Craddock; Gordon Broderick; Maria Abreu; Kristina Aenlle; Drew A Helmer; J Wesson Ashford; Kimberly Sullivan; Alison Bested; Devra Cohen; Dikoma Shungu; Helena Chandler; Mary Ann Fletcher; Maxine Krengel; Nancy Klimas

doi:10.1016/j.lfs.2021.119636

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

Amanpreet K Cheema
, Rebecca B McNeil
, Travis Craddock
, Gordon Broderick
, Maria Abreu
, Kristina Aenlle
, Drew A Helmer
, J Wesson Ashford
, Kimberly Sullivan
, Alison Bested
, Devra Cohen
, Dikoma Shungu
, Helena Chandler
, Mary Ann Fletcher
, Maxine Krengel
, Nancy Klimas

College of Psychology

Research output: Contribution to journal › Article › peer-review

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.

Original language	American English
Article number	119636
Journal	Life Sciences
Volume	278
DOIs	https://doi.org/10.1016/j.lfs.2021.119636
State	Published - Aug 1 2021

Bibliographical note

Publisher Copyright:
© 2021

Funding

Funding sources: This work was funded by the United States Department of Defense Congressionally Directed Medical Research Programs (CDMRP; http://cdmrp.army.mil/ ) [grant number W81XWH1820062 ] and in part by the Houston VA Health Services Research & Development Center for Innovations [grant number CIN13-413 ]. The opinions and assertions contained herein are the private views of the authors and do not reflect the views of the United States Department of Defense or the United States Department of Veterans Affairs. The funding agency had no role in the decision to submit the manuscript for publication. The authors acknowledge our Veterans’ Advocacy Committee members Jimmy Arocho, Marylyn Harris, Denise Nichols, Marshall Harvey, and T. Anthony Langeland for advocacy efforts in support of science and veterans. Funding sources: This work was funded by the United States Department of Defense Congressionally Directed Medical Research Programs (CDMRP; http://cdmrp.army.mil/) [grant number W81XWH1820062] and in part by the Houston VA Health Services Research & Development Center for Innovations [grant number CIN13-413]. The opinions and assertions contained herein are the private views of the authors and do not reflect the views of the United States Department of Defense or the United States Department of Veterans Affairs. The funding agency had no role in the decision to submit the manuscript for publication. The authors acknowledge our Veterans? Advocacy Committee members Jimmy Arocho, Marylyn Harris, Denise Nichols, Marshall Harvey, and T. Anthony Langeland for advocacy efforts in support of science and veterans.

Funders	Funder number
United States Department of Defense Congressionally Directed Medical Research Programs
VA Health Services Research & Development Center for Innovations	CIN13-413
U.S. Department of Defense
Congressionally Directed Medical Research Programs	W81XWH1820062
Department of Veterans Affairs

ASJC Scopus Subject Areas

General Pharmacology, Toxicology and Pharmaceutics
General Biochemistry,Genetics and Molecular Biology

Keywords

Gulf War
Persian Gulf syndrome
biomedical research
clinical trials as topic
disease management
humans
research design
veterans health
Military exposures
Clinical trials
Gulf War Illness
Veterans health
Research networks

Disciplines

Psychology

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10.1016/j.lfs.2021.119636

https://doi.org/10.1016/j.lfs.2021.119636

Cite this

Cheema, A. K., McNeil, R. B., Craddock, T., Broderick, G., Abreu, M., Aenlle, K., Helmer, D. A., Ashford, J. W., Sullivan, K., Bested, A., Cohen, D., Shungu, D., Chandler, H., Fletcher, M. A., 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, Article 119636. https://doi.org/10.1016/j.lfs.2021.119636

Cheema, AK, McNeil, RB, Craddock, T, Broderick, G, Abreu, M, Aenlle, K, Helmer, DA, Ashford, JW, Sullivan, K, Bested, A , Cohen, D, Shungu, D, Chandler, H, Fletcher, MA, Krengel, M & Klimas, N 2021, 'Gulf War Illness Clinical Trials and Interventions Consortium (GWICTIC): A collaborative research infrastructure for intervention and implementation.', Life Sciences, vol. 278, 119636. https://doi.org/10.1016/j.lfs.2021.119636

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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.",

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doi = "10.1016/j.lfs.2021.119636",

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AU - Broderick, Gordon

AU - Abreu, Maria

AU - Aenlle, Kristina

AU - Helmer, Drew A

AU - Ashford, J Wesson

AU - Sullivan, Kimberly

AU - Bested, Alison

AU - Cohen, Devra

AU - Shungu, Dikoma

AU - Chandler, Helena

AU - Fletcher, Mary Ann

AU - Krengel, Maxine

AU - Klimas, Nancy

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ER -

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

Abstract

Bibliographical note

Funding

ASJC Scopus Subject Areas

Keywords

Disciplines

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