I am pleased to announce that the One Mind-supported Transforming Research and Clinical Knowledge and Traumatic Brain Injury Study (TRACK-TBI) enrolled its first patient on February 28, 2014. This is the first of 3,000 patients who will be enrolled in the study at 11 trauma centers in over the next several years. In the world of medical research, the “launch” is an important milestone not unlike the opening day of the baseball season.
TRACK-TBI is not baseball but there are analogies that apply. The Track-TBI Pilot that enrolled and followed 652 patients for over a year was not unlike baseball’s spring training. Comprehensive patient data was gathered and analyzed, and valuable research was published. The successes of a small team attracted others, which has led to TRACK-TBI expanding to 11 enrollment sites across the country, joining together some of the most talented and respected clinicians and researchers in the field of neurotrauma.
The fact that the TRACK-TBI investigators decided to join in a multi-center collaboration, rather than compete individually for the ~$18M NIH/NINDS grant, shows that there is truly something special about this team of all-stars. Each would have been a front-runner to win the grant had they submitted their own proposal. Instead, they agreed to be part of a team that meant they would get 1/11th of the entire grant if the team won, and it did, rather than the entire amount had they competed alone and been successful. Furthermore, conducting these studies is far from easy in terms of resources and logistics. This research is not like cancer or Alzheimer’s research. The TRACK-TBI research protocol requires patients to be enrolled within 24-hours of their injuries. The dedication of the teams at each study site to go above and beyond is commendable. Study personnel make personal sacrifices and don’t work 9 to 5, Monday to Friday shifts because trauma patients arrive in the emergency room 24 hours a day, seven days a week (most injuries occur outside normal business hours).
TRACK-TBI Information Commons
The building of the TRACK-TBI Information Commons, with the support of One Mind, represents many years of work that has put our “team” in position to improve the diagnosis, prognosis and treatment of TBI.
Although TRACK-TBI represents one of the largest, cutting-edge studies of TBI and PTS, there is still so much to do. The available funding for TRACK-TBI was only a fraction of that provided for similar studies in other diseases, such as Alzheimer’s. The goal of One Mind is to close this gap in resources. We want to raise sufficient funds so that every patient in the TRACK-TBI study will have access to advanced imaging and comprehensive outcome assessment. With your help, we can leverage the existing NIH funds to make this the most important TBI and PTS study of our generation.
In addition to TRACK-TBI, One Mind is supporting Dr. Andrew Maas’ and Dr. David Menon’s CENTER-TBI, a €30M TBI study funded by the European Union. Center-TBI is expected to launch enrollment in October 2014, and is working very closely with the TRACK-TBI Team. In fact, they will share data throughout the duration of their studies. Using similar protocols to TRACK-TBI, CENTER-TBI will add another ~6,000 patients to the database.
While the success of TRACK-TBI and CENTER-TBI relies entirely on the expertise and willing collaboration of the researchers, this team of teams is generally following One Mind’s Open Science Principles, and so we are providing important support. Because of your generosity, that support currently includes the following:
- Continued development of the Apollo Knowledge Data Portal. Version 2.0 is nearing completion and will be available for the TRACK-TBI and CENTER-TBI Teams to use for collaboration and analysis of their data sets.
- Conversion of the NIH/NINDS Traumatic Brain Injury Common Data Elements (TBI CDEs) to the format approved by the FDA, the Clinical Data Interchange Standards Consortium (CDISC). This will significantly cut down on the time required for FDA acceptance of critical TRACK-TBI Data – and all other TBI studies using the NINDS TBI CDEs.
- Funding of data curation (e.g., ensuring data completeness and adherence to CDEs) with our partners from Thompson Reuters.
- Provision of supplemental stipends and transportation at all 11 TRACK-TBI enrollment locations to improve patient follow-up. We know that these patients are historically difficult to follow and as a result of their injuries not always able to drive themselves to appointments. Support from One Mind is critical to guarantee follow-up visits for those patients enrolled in this longitudinal study.
- Promoting the use of the QuesGen electronic clinical data capture platform for CENTER-TBI. This data collection tool, developed for the TRACK-TBI, will be shared with CENTER-TBI investigators and other interested TBI and PTS researchers to help standardize data capture. We are also exploring the possibility of helping QuesGen move to open source that would allow it to be available on Apollo.
- Funding the complete informatics backbone for CENTER-TBI to include the use of QuesGen at ~80 enrollment sites throughout Europe.
- And finally, working with a number of new donors to fund the design, launch, and operation of PatientsLikeMe online TBI and PTS patient communities. This project is exciting because if we are able to fund it, researchers will have an amazing source of patient data to augment that which they collect clinically. And even more importantly, patients and their families will have a place they can go to gain information that will allow them to be better advocates as they seek treatment for themselves and those they love.
None of this would be possible without your help. Patients and clinicians are desperate to have better tools to diagnose and treat TBI and PTS. In the world of research we are experiencing a rare moment when an amazing team of TBI clinicians and researchers have come together to collaborate, share data, and find answers. Because this has happened, we will find better diagnostics and treatments for TBI and PTS in a fraction of the time it would take had you not supported One Mind. This is our World Series!
Pete Chiarelli, CEO
The Summit – “Reengineering the Incentive System,”
May 13-15, 2014, Washington DC
As successful as we have been as enablers for this team of teams, the theme of this year’s One Mind Summit reflects what we think is an incentive system that forces even those who know change is required, but still support the status quo, to commit to collaboration and data sharing. This year, One Mind’s Third Annual Summit will have a single focus. We will address barriers and incentives to collaboration and sharing data in medical research.
We believe that a key component of accelerating research in neuroscience is to encourage collaboration, versus competition, and enable data sharing. To that end, One Mind supports open science principles to encourage the creation and sharing of useful research data.
The benefits of analyzing very large data sets are now widely recognized in fields ranging from genetics to imaging to healthcare delivery. However, there are a significant number of disincentives to creating what has been called “data liquidity” and overall data value, many of which One Mind has encountered in the course of implementing its open science approach.
These disincentives affect the access and usefulness of data to the research and patient communities, and may thus impede the development and dissemination of knowledge. To realize the full benefits of data sharing, the dots must be joined from the way in which research is funded, investigator are supported and promoted, all the way to publication of an academic paper, and to the use of research data in translational medicine and patient care.
Factors that deserve attention include informed consents for broader data use, patient and IRB concerns over privacy and security of personal data, national and international data regulations, intellectual property policies, academic incentives for advancement, publishing models, the goals of grant making bodies, and the pressing issue of the replicability of research. Grant makers, publishers, and scientific communities should give consideration to technical and scientific requirements that will make data maximally useful and most likely to be shared. Strategies, most notably from grant makers, could include requirements for enforceable data sharing plans and a focus on data usefulness, such as use of common data elements and formats that are acceptable to the broader scientific community, regulators, and industry.
Our goal is to examine how current systems for recording, storing, and sharing data could be reengineered to overcome each of the barriers we have identified. Each speaker panel will address a particular obstacle or disincentive to data sharing and propose next steps. For such a goal to be effective we must acknowledge the interests of all involved: patients, clinicians, researchers, regulators, industry innovators and others.
Response to the focus of the Summit has been tremendous. Following the conference, we plan to propose and publish consensus proposals for further action—with the needs of the patient as the guiding principle.