Developing modern criteria for diagnosis and severity classification in TBI, and identifying more homogenous endotypes are of global interest. Consequently; the concept of an InTBIR initiative was developed by international experts and policy makers at a 2011 symposium of the American Association for the Advancement of Science (AAAS) annual meeting. In 2012, the concept of InTBIR was actualized as an effort to combine resources and focus on improving outcomes and lessening the global burden of TBI by 2020. In the original InTBIR Memorandum of Understanding, InTBIR’s first phase was to enhance both international collaboration and data sharing through an emphasis on structured harmonized data collection. Starting with the coordination of TRACK-TBI and CENTER-TBI, the stated goal was to develop a clinical research ecosystem that allowed for the exchange of data, analytics, and clinical expertise, internationally. The ultimate impact of this effort is to accelerate knowledge that will inform clinical practice guidelines and improve current practices and treatments for TBI patient outcomes.
At its inception, InTBIR formed as a pragmatic cooperative consortium of funding agencies from the European Union, the United States, and Canada (InTBIR; Lancet 2012, 2013). The three founding members included the Health Directorate of the European Commons (EC), the NIH’s National Institute of Neurological Disorders and Stroke (NINDS), and the Canadian Institutes of Health Research (CIHR). Subsequently, several affiliated organizational members have joined: One Mind (2015), the U.S Department of Defense (2016), and the Ontario Brain Institute (2017). During the first phase of InTBIR, each organization was dedicated to spending at least $1 million USD / year on TBI Comparative Effectiveness Research (CER) and/or natural history studies or related collaborative infrastructure. The first phase of this initiative was organized though governmental organizations using targeted international TBI funding opportunities and relied on the engagement of clinicians and scientists from many public and private institutions throughout its development and implementation. Five years later, the InTBIR initiative has clearly provided important groundwork for the desired international open science ecosystem in clinical TBI research. Now, as the InTBIR initiative transitions to Phase 2, the momentum and successes in data sharing and international coordination of clinical activities will continue; however, the organizational structure will transform from a shared model between funders and principal investigators to a model led primarily by Work Groups of research scientists, clinicians and other key stakeholders. This transformation will maintain collaboration among the stakeholders, including but not limited to the principal investigators and funding organizations, as InTBIR looks to sustain the open science ecosystem that has been established.
The future of the InTBIR initiative should include a broad global community, which will require continued development of a controlled-access, high-quality dataset. Current and incoming participating organizations, investigators, and research teams should have the expectation that their data and protocols will be harmonized using Common Data Elements and shared protocols, and shared with other qualified researchers to enable secondary analysis and validation studies. The role of the funding agencies in this effort will be to enable the open science environment by 1) providing support for the continuation of the InTBIR Work Groups (described below), 2) encouraging and providing logistical support for in-person meetings, and 3) informing participants of funding and/or scientific opportunities within their agency. As the size and complexity of the InTBIR datasets increase and data sharing efforts advance, there will be a need for funders to consider appropriately sourcing these activities, e.g. to allow for recruiting multi-disciplinary researchers (e.g., bioinformatics, health economist) to assist in the analysis and interpretation of these complex data.
The success of this initiative can be assessed based on progress toward the stated benchmarks, quantification of its impact (described below), and ultimately by demonstrating progress towards InTBIR’s ultimate mission of reducing the global burden of TBI.
Working together to improve outcomes and lessen the global burden of traumatic brain injury by 2020
InTBIR is a cooperative effort of the European Commission (EC), the Canadian Institutes of Health Research (CIHR) and the National Institutes of Health (NIH) to coordinate and leverage clinical research activities on traumatic brain injury (TBI) research. InTBIR’s goal is to improve health care and lessen the global burden of TBI by 2020 through the discovery of causal relationships between treatments and clinically meaningful outcomes. InTBIR seeks to encourage well-designed, hypothesis-driven studies that include the collection of high quality data followed by rigorous statistical analysis.
Please see “Towards an international initiative for traumatic brain injury research” for more details.
InTBIR Previous Organization
InTBIR is intended to be a pragmatic collaboration with less emphasis on its own structure and administration and more emphasis on enabling the exchange of information and data from coordinated international TBI clinical studies. Nonetheless, some structure is desired to guide and optimize the collaborative research efforts. InTBIR is made up of Funding Organization Liaisons, a Scientific Steering Committee, an International Scientific Advisory Board (ISAB), and four Working Groups. Please see InTBIR Memorandum of Cooperation for more details.
Funding Organization Liaisons
Dr. Tim Raemaekers
DG Research and Innovation, European Commission
Dr. Patrick Bellgowan
Program Director, NIH/NINDS
Dr. Nsini Umoh
Program Director - TBI, NIH/NINDS
Dr. Mona Hicks
Chief Science Officer, One Mind
Scientific Steering Committee
Dr. Hester Lingsma
Erasmus MC University Medical Center Rotterdam
Dr. Geoffrey Manley
University of California, San Francisco
Dr. David Menon
University of Cambridge
Dr. David Okonkwo
University of Pittsburgh
International Scientific Advisory Board
Dr. Jan Bjaalie
Institute of Basic Medical Sciences
Dr. Carl Kesselman
Director, Informatics Division, University of Southern California
Dr. Franco Servadei
University Hospitals of Parma and Reggio Emilia
Dr. Michael Weiner
University of California San Francisco, School of Medicine
Charge: The Biomarkers Work Group oversees standardization of protocols required for biomarkers and quality control metrics, and standardized analysis, as well as development of a catalog of samples.
Co-Chairs: Stefania Mondello and Kevin Wang
Executive Committee Liaison: Elizabeth Theriault
Members: Ramone Diaz-Arrastia, Andras Buki, Endre Czeiter, Jamie Hutchison, Roberto Latini, Serge Masson, David Okonkwo, Ava Puccio, Diane Stephenson, Cheryl Wellington
Data Management & Analytics
Charge: The Data Analytics Work Group interests include CER questions and objectives, clinical endpoints, and analytical methods.
Co-Chairs: Tony Fabio, Hester Lingsma and Lindsay Wilson,
Executive Committee Liaisons: Mona Hicks and Nsini Umoh
Members: Matt McAuliffe, Guido Bertolini, Jan Bjallie, Vibeke Brinck, Ari Ercole, Lou French, Pradeep George, Joe Giacino, Jeff Grethe, Mike Jarrett, Tania Khasanova, Ferath Kherif, Geoff Manley, Sirimon O'Charoen, Ewout Steyerberg, Nancy Temkin, Anthony Vaccarino, Mary Vassar, Keith Yeates, Steve Wisniewski
Documents: Data Management & Analytics WG Progress Update (2016 to 2018)
Charge: The Neuroimaging Work Group coordinate among InTBIR members to define methods and standards for the sharing of raw and processed neuroimaging data.
Co-Chairs: Pratik Mukherjee and Inga Korte
Executive Committee Liaison: Patrick Bellgowan
Members: Luca Antiga, Karen Barlow, Mark Daley, Bradley Goodyear, Christine MacDonald, Ravi Menon, Bedda Rosario, Jan Verheyde, Thijs Vande Vyvere
Charge: The Policies Work Group provides guidance on procedures and policies for data sharing and protection, informed consent management, publications, and other areas as needed.
Co-Chairs: Joanne Fleming and Isabelle Gagnon
Executive Committee Liaisons: Stephane Hogan and Carol Taylor-Burds
Members: Ramon Diaz-Arrastia, Giuseppe Citerio, Carolyn Emery, Ferath Kherif, Nick Reed, Laurie Silfies
Documents: InTBIR Data Sharing Principles