The Traumatic Brain Injury Endpoints Development (TED) Initiative: Progress on a Public-Private Regulatory Collaboration to Accelerate Diagnosis and Treatment of Traumatic Brain Injury

Journal of Neurotrauma

Volumn 34, Issue 19, 2017, Pages 2721-2730

  Manley, Geoffrey T ^a   Mac Donald, Christine L ^b   Markowitz, Amy J ^a   Stephenson, Diane ^c   Robbins, Ann ^c   Gardner, Raquel C ^d   Winkler, Ethan ^a   Bodien, Yelena G ^e   Taylor, Sabrina R ^a   Yue, John K ^a   Kannan, Lakshmi ^f   Kumar, Allison ^g   McCrea, Michael A ^h   Wang, Kevin K ⁱ  

^a UNIVERSITY OF CALIFORNIA   (United States)

^b UNIVERSITY OF WASHINGTON SCHOOL OF MEDICINE   (United States)

^c CRITICAL PATH INSTITUTE   (United States)

^d UNIVERSITY OF CALIFORNIA   (United States)

^e HARVARD MEDICAL SCHOOL   (United States)

^f CENTER FOR DEVICES AND RADIOLOGICAL HEALTH   (United States)

^g Independent Consultant   (United States)

^h MEDICAL COLLEGE OF WISCONSIN   (United States)

ⁱ UNIVERSITY OF FLORIDA COLLEGE OF MEDICINE   (United States)

Author keywords

biomarkers; clinical outcome measures; CT; FDA; MRI; traumatic brain injury

Indexed keywords

BIOLOGICAL MARKER; GLIAL FIBRILLARY ACIDIC PROTEIN; UBIQUITIN CARBOXY TERMINAL HYDROLASE ISOZYME L1; UBIQUITIN THIOLESTERASE; UNCLASSIFIED DRUG;

ARTICLE; AXONAL INJURY; BRAIN CONTUSION; COMPUTER ASSISTED TOMOGRAPHY; CONSENSUS; FOOD AND DRUG ADMINISTRATION; HUMAN; NEUROIMAGING; NUCLEAR MAGNETIC RESONANCE IMAGING; OUTCOME ASSESSMENT; PROGNOSIS; PUBLIC-PRIVATE PARTNERSHIP; STANDARDIZATION; TRAUMATIC BRAIN INJURY;

EID: 85030087656     PISSN: 08977151     EISSN: 15579042     Source Type: Journal    
DOI: 10.1089/neu.2016.4729     Document Type: Article

References (61)

1. Coronado, V.G., McGuire, L.C., Sarmiento, K., Bell, J., Lionbarger, M.R., Jones, C.D., Geller, A.I., Khoury, N., and Xu, L. (2012). Trends in traumatic brain injury in the U.S. and the public health response: 1995-2009. J. Safety Res. 43, 299-307.
2. Centers for Disease Control and Prevention. (2011). Nonfatal traumatic brain injuries related to sports and recreation activities among persons aged
3. Centers for Disease Control and Prevention (CDC), National Center for Injury Prevention and Control. (2003). Report to Congress on mild traumatic brain injury in the United States: steps to prevent a serious public health problem. Centers for Disease Control and Prevention: Atlanta, GA.
4. Faul, M., Xu, L., Wald, M.M., Coronado, V., and Dellinger, A.M. (2010). Traumatic brain injury in the United States: national estimates of prevalence and incidence, 2002-2006. Inj. Prev. 16, A268-A268.
5. Plassman, B.L., Havlik, R.J., Steffens, D.C., Helms, M.J., Newman, T.N., Drosdick, D., Phillips, C., Gau, B.A., Welsh-Bohmer, K.A., Burke, J.R., Guralnik, J.M., and Breitner, J.C. (2000). Documented head injury in early adulthood and risk of Alzheimers disease and other dementias. Neurology 55, 1158-1166.
6. Omalu, B., Hammers, J.L., Bailes, J., Hamilton, R.L., Kamboh, M.I., Webster, G., and Fitzsimmons, R.P. (2011). Chronic traumatic encephalopathy in an Iraqi war veteran with posttraumatic stress disorder who committed suicide. Neurosurg. Focus 31, E3.
7. DeKosky, S.T., Blennow, K., Ikonomovic, M.D., and Gandy, S. (2013). Acute and chronic traumatic encephalopathies: pathogenesis and biomarkers. Nat. Rev. Neurol. 9, 192-200.
8. Thurman, D.J., Alverson, C., Dunn, K.A., Guerrero, J., and Sniezek, J.E. (1999). Traumatic brain injury in the United States: A public health perspective. J. Head Trauma Rehabil. 14, 602-615.
9. Research!America. (2013). Investment in research saves lives and money. [Fact sheet]. Arlington, VA. http://www.researchamerica.org/sites/default/files/TBI-%202016.pdf (last accessed June 20, 2017).
10. Haas, M., Mantua, V., Haberkamp, M., Pani, L., Isaac, M., Butlen-Ducuing, F., Vamvakas, S., and Broich, K. (2015). The European Medicines Agencys strategies to meet the challenges of Alzheimer disease. Nat. Rev. Drug Discov. 14, 221-222.
11. Kozauer, N., and Katz, R. (2013). Regulatory innovation and drug development for early-stage Alzheimers disease. N. Engl. J. Med. 368, 1169-1171.
12. Butlen-Ducuing, F., Petavy, F., Guizzaro, L., Zienowicz, M., Haas, M., Alteri, E., Salmonson, T., and Corruble, E. (2016). Regulatory watch: challenges in drug development for central nervous system disorders: A European Medicines Agency perspective. Nat. Rev. Drug Discov. 15, 813-814.
13. FDA. (2015). Targeted drug development: why are many diseases lagging behind? FDA: Silver Spring, MD.
14. Teasdale, G., and Jennett, B. (1974). Assessment of coma and impaired consciousness. A practical scale. Lancet 2, 81-84.
15. Ruff, R.M., Iverson, G.L., Barth, J.T., Bush, S.S., and Broshek, D.K.; NAN Policy and Planning Committee. (2009). Recommendations for diagnosing a mild traumatic brain injury: A National Academy of Neuropsychology education paper. Arch. Clin. Neuropsychol. 24, 3-10.
16. Defense Centers of Excellence for Psychological Health and Traumatic Brain Injury. (2010). Department of Defense Coding Guidance for Traumatic Brain Injury Fact Sheet [Fact Sheet]. Silver Spring, MD. http://dcoe.mil/files/Fact-Sheet-Summarizing-VA-DoD-Evidence-Based-Clinical-Practice-Guidelines-for-Management-of-Concussion-Mild-Traumatic-Brain-Injury.pdf (last accessed June 20, 2017).
17. Furger, R.E., Nelson, L.D., Brooke Lerner, E., and McCrea, M.A. (2016). Frequency of Factors that Complicate the Identification of Mild Traumatic Brain Injury in Level I Trauma Center Patients. Concussion 1, Future Medicine, Ltd. on behalf of the Drake Foundation, London, United Kingdom.
18. Wilson, J.T., Pettigrew, L.E., and Teasdale, G.M. (1998). Structured interviews for the Glasgow Outcome Scale and the extended Glasgow Outcome Scale: guidelines for their use. J. Neurotrauma 15, 573-585.
19. Rubiano, A.M., Carney, N., Chesnut, R., and Puyana, J.C. (2015). Global neurotrauma research challenges and opportunities. Nature 527, S193-S197.
20. Tosetti, P., Hicks, R.R., Theriault, E., Phillips, A., Koroshetz, W., and Draghia-Akli, R. (2013). Toward an international initiative for traumatic brain injury research. J. Neurotrauma 30, 1211-1222.
21. Garber, K. (2007). Stroke treatment-light at the end of the tunnel? Nat. Biotechnol. 25, 838-840.
22. FDA. (2015). Critical Path Initiave. FDA: Silver Spring, MD.
23. Woodcock, J., Buckman, S., Goodsaid, F., Walton, M.K., and Zineh, I. (2011). Qualifying biomarkers for use in drug development: A US Food and Drug Administration overview. Expert Opin. Med. Diagn. 5, 369-374.
24. Woodcock, J., Griffin, J.P., and Behrman, R.E. (2011). Development of novel combination therapies. N. Engl. J. Med. 364, 985-987.
25. FDA. (2016). Biomarker Qualification Program. FDA: Silver Spring, MD.
26. CDER. (2014). Qualification Process for Drug Development Tools. FDA Center for Drug Evaluation and Research: Silver Spring, MD.
27. EMA. (2009). Qualification of novel methdologies for drug development: guidance to applicants. European Medicines Agency: London.
28. FDA. (2015). Manual of policies & procedures. FDA: Silver Spring, MD.
29. Isaac, M., and Gispen-de Wied, C. (2015). CNS biomarkers: potential from a regulatory perspective: case study-focus in low hippocampus volume as a biomarker measured by MRI. Eur. Neuropsychopharmacol. 25, 1003-1009.
30. Hill, D.L., Schwarz, A.J., Isaac, M., Pani, L., Vamvakas, S., Hemmings, R., Carrillo, M.C., Yu, P., Sun, J., Beckett, L., Boccardi, M., Brewer, J., Brumfield, M., Cantillon, M., Cole, P.E., Fox, N., Frisoni, G.B., Jack, C., Kelleher, T., Luo, F., Novak, G., Maguire, P., Meibach, R., Patterson, P., Bain, L., Sampaio, C., Raunig, D., Soares, H., Suhy, J., Wang, H., Wolz, R., and Stephenson, D. (2014). Coalition Against Major Diseases/European Medicines Agency biomarker qualification of hippocampal volume for enrichment of clinical trials in predementia stages of Alzheimers disease. Alzheimers Dement. 10, 421-429.e3.
31. McMurry-Heath, M., and Hamburg, M.A. (2012). Creating a space for innovative device development. Sci. Transl. Med. 4, 163fs143.
32. OCallaghan, K. (2013). Medical Device Development Tools, Draft Guidance for Industry, Tool Developers, and Food and Drug Administration Staff. FDA: Silver Spring, MD.
33. FDA. (2015). Drug Development Tools (DDT) Qualification Programs. FDA: Silver Spring, MD.
34. Lavezzari, G., and Womack, A.W. (2016). Industry perspectives on biomarker qualification. Clin. Pharmacol. Ther. 99, 208-213.
35. Fehnel, S., DeMuro, C., McLeod, L., Coon, C., and Gnanasakthy, A. (2013). US FDA patient-reported outcome guidance: great expectations and unintended consequences. Expert Rev. Pharmacoecon. Outcomes Res. 13, 441-446.
36. Wang, K.K., Stephenson, D., Robbins, A., Markowitz, A., Diaz-Arrastia, R., Jeromin, A., and Manley, G. (2015). TRACK-TBI and TED team response to FDA biomarker RFI. https://www.regulations .gov/document?D=FDA-2014-N-2187-0015 (last accessed June 20, 2017).
37. Muhkerjee, P., Mac Donald, C., Stephenson, D., Robbins, A., Markowitz, A. and Manley, G. (2015). TRACK-TBI and TED team response to FDA biomarker RFI. https://www.regulations.gov/document? D=FDA-2014-N-2187-0022 (last accessed June 20, 2017).
38. Manley, G.T. and the TED Investigators. (2016). Clinical Outcome Assessment Compendium Request for Comments. https://www .regulations.gov/document?D=FDA-2015-N-5106-0010 (last accessed June 20, 2017).
39. TRACK-TBI-Investigators. (2015). TED Metadataset. Traumatic Brain Injury Endpoints (TED) Initiative: San Francisco, CA.
40. Clinical Data Interchange Standards Consortium (CDISC). (2016). Traumatic Brain Injury Therapeutic Area Data Standard User Guide v1, Austin, TX.
41. Saatman, K.E., Duhaime, A.C., Bullock, R., Maas, A.I., Valadka, A., and Manley, G.T.; ; Workshop Scientific Team and Advisory Panel Members. (2008). Classification of traumatic brain injury for targeted therapies. J. Neurotrauma 25, 719-738.
42. Duhaime, A.C., Gean, A.D., Haacke, E.M., Hicks, R., Wintermark, M., Mukherjee, P., Brody, D., Latour, L., and Riedy, G.; Common Data Elements Neuroimaging Working Group Members, Pediatric Working Group Members. (2010). Common data elements in radiologic imaging of traumatic brain injury. Arch. Phys. Med. Rehabil. 91, 1661-1666.
43. Wilde, E.A., and Levin, H.S. (2010). Introduction to the special issue on the use of advanced structural neuroimaging techniques in understanding brain-behavior relationships. Dev. Neuropsychol. 35, 231-232.
44. Yue, J.K., Vassar, M.J., Lingsma, H.F., Cooper, S.R., Okonkwo, D.O., Valadka, A.B., Gordon, W.A., Maas, A.I., Mukherjee, P., Yuh, E.L., Puccio, A.M., Schnyer, D.M., and Manley, G.T.; ; TRACK-TBI Investigators. (2013). Transforming research and clinical knowledge in traumatic brain injury pilot: multicenter implementation of the common data elements for traumatic brain injury. J. Neurotrauma 30, 1831-1844.
45. Manley, G.T., Diaz-Arrastia, R., Brophy, M., Engel, D., Goodman, C., Gwinn, K., Veenstra, T.D., Ling, G., Ottens, A.K., Tortella, F., and Hayes, R.L. (2010). Common data elements for traumatic brain injury: recommendations from the biospecimens and biomarkers working group. Arch. Phys. Med. Rehabil. 91, 1667-1672.
46. Smith, D.H., Hicks, R.R., Johnson, V.E., Bergstrom, D.A., Cummings, D.M., Noble, L.J., Hovda, D., Whalen, M., Ahlers, S.T., LaPlaca, M., Tortella, F.C., Duhaime, A.C., and Dixon, C.E. (2015). Pre-clinical traumatic brain injury common data elements: Toward a common language across laboratories. J. Neurotrauma 32, 1725-1735.
47. Romero, K., Ito, K., Rogers, J.A., Polhamus, D., Qiu, R., Stephenson, D., Mohs, R., Lalonde, R., Sinha, V., Wang, Y., Brown, D., Isaac, M., Vamvakas, S., Hemmings, R., Pani, L., Bain, L.J., and Corrigan, B.; ; Alzheimers Disease Neuroimaging Initiative; Coalition Against Major Diseases. (2015). The future is now: model-based clinical trial design for Alzheimers disease. Clin. Pharmacol. Ther. 97, 210-214.
48. Stephenson, D., Hu, M.T., Romero, K., Breen, K., Burn, D., Ben-Shlomo, Y., Bhattaram, A., Isaac, M., Venuto, C., Kubota, K., Little, M.A., Friend, S., Lovestone, S., Morris, H.R., Grosset, D., Sutherland, M., Gallacher, J., Williams-Gray, C., Bain, L.J., Aviles, E., Marek, K., Toga, A.W., Stark, Y., Forrest Gordon, M., and Ford, S. (2015). Precompetitive data sharing as a catalyst to address unmet needs in Parkinsons disease. J. Parkinsons Dis. 5, 581-594.
49. Department of Defense, Department of Veterans Affairs, Department of Health and Human Services, Department of Education. (2013). National Research Action Plan, Responding to the Executive Order Improving Access to Mental Health Services for Veterans, Service Members, and Military Families, Washington, DC.
50. Amur, S., LaVange, L., Zineh, I., Buckman-Garner, S., and Woodcock, J. (2015). Biomarker qualification: Toward a multiple stakeholder framework for biomarker development, regulatory acceptance, and utilization. Clin. Pharmacol. Ther. 98, 34-46.
51. Amur, S.G., Sanyal, S., Chakravarty, A.G., Noone, M.H., Kaiser, J., McCune, S., and Buckman-Garner, S.Y. (2015). Building a roadmap to biomarker qualification: challenges and opportunities. Biomark. Med. 9, 1095-1105.
52. FDA. (2015). PrecisionFDA. FDA: Silver Spring, MD.
53. Bahcall, O. (2015). Precision medicine. Nature 526, 335-370.
54. Faster-Cures. (2015). Consortia-pedia. Millken Institute, Santa Monica, CA.
55. Snyder, H.M., Carrillo, M.C., Grodstein, F., Henriksen, K., Jeromin, A., Lovestone, S., Mielke, M.M., OBryant, S., Sarasa, M., Sjogren, M., Soares, H., Teeling, J., Trushina, E., Ward, M., West, T., Bain, L.J., Shineman, D.W., Weiner, M., and Fillit, H.M. (2014). Developing novel blood-based biomarkers for Alzheimers disease. Alzheimers Dement. 10, 109-114.
56. Weiner, M.W., Veitch, D.P., Aisen, P.S., Beckett, L.A., Cairns, N.J., Cedarbaum, J., Donohue, M.C., Green, R.C., Harvey, D., Jack, C.R., Jr., Jagust, W., Morris, J.C., Petersen, R.C., Saykin, A.J., Shaw, L., Thompson, P.M., Toga, A.W., and Trojanowski, J.Q.; Alzheimers Disease Neuroimaging Initiative. (2015). Impact of the Alzheimers Disease Neuroimaging Initiative, 2004 to 2014. Alzheimers Dement. 11, 865-884.
57. Yuh, E.L., Mukherjee, P., Lingsma, H.F., Yue, J.K., Ferguson, A.R., Gordon, W.A., Valadka, A.B., Schnyer, D.M., Okonkwo, D.O., Maas, A.I., and Manley, G.T.; TRACK-TBI Investigators. (2013). Magnetic resonance imaging improves 3-month outcome prediction in mild traumatic brain injury. Ann. Neurol. 73, 224-235.
58. Lingsma, H.F., Yue, J.K., Maas, A.I., Steyerberg, E.W., and Manley, G.T.; TRACK-TBI Investigators. (2015). Outcome prediction after mild and complicated mild traumatic brain injury: external validation of existing models and identification of new predictors using the TRACK-TBI pilot study. J. Neurotrauma 32, 83-94.
59. McMahon, P., Hricik, A., Yue, J.K., Puccio, A.M., Inoue, T., Lingsma, H.F., Beers, S.R., Gordon, W.A., Valadka, A.B., Manley, G.T., and Okonkwo, D.O.; TRACK-TBI Investigators. (2014). Symptomatology and functional outcome in mild traumatic brain injury: results from the prospective TRACK-TBI study. J. Neurotrauma 31, 26-33.
60. Ratcliff, J.J., Adeoye, O., Lindsell, C.J., Hart, K.W., Pancioli, A., McMullan, J.T., Yue, J.K., Nishijima, D.K., Gordon, W.A., Valadka, A.B., Okonkwo, D.O., Lingsma, H.F., Maas, A.I., and Manley, G.T.; TRACK-TBI Investigators. (2014). ED disposition of the Glasgow Coma Scale 13 to 15 traumatic brain injury patient: Analysis of the Transforming Research and Clinical Knowledge in TBI study. Am. J. Emerg. Med. 32, 844-850.
61. Yuh, E.L., Cooper, S.R., Mukherjee, P., Yue, J.K., Lingsma, H.F., Gordon, W.A., Valadka, A.B., Okonkwo, D.O., Schnyer, D.M., Vassar, M.J., Maas, A.I., and Manley, G.T.; TRACK-TBI Investigators. (2014). Diffusion tensor imaging for outcome prediction in mild traumatic brain injury: A TRACK-TBI study. J. Neurotrauma 31, 1457-1477.