Challenges to effective research in acute trauma resuscitation: Consent and endpoints

John B. Holcomb, Richard Weiskopf, Howard Champion, Steven A. Gould, R. Michelle Sauer, Karen Brasel, Grant Bochicchio, Eileen Bulger, Bryan A. Cotton, Daniel Davis, Richard Dutton, Carl J. Hauser, John R. Hess, George A. Hides, Paula Knudson, Ellen MacKenzie, Robert L. McGinnis, Joel Michalek, Frederick A. Moore, Laurel OmertBrad H. Pollock, Bartholomew Tortella, Jeremy Sugarman, Martin Schreiber, Charles E. Wade

    Research output: Contribution to journalArticle

    34 Citations (Scopus)

    Abstract

    Selection of study endpoints is one of the most important decisions in the design of effective clinical trials. Late mortality (e.g., 28 days) is an unambiguous endpoint, accepted by regulatory agencies, but it is viewed as problematic among researchers in the study of resuscitation for acute trauma injury with hemorrhagic shock. In February 2008, physicians, ethicists, statisticians, and research scientists from the military, academia, industry, the Federal Drug Administration, and the National Heart Lung and Blood Institute gathered to discuss the obstacles confronting the trauma community in their efforts to improve patient outcomes. The primary meeting objective was to generate preliminary suggestions for a series of follow-up meetings that will develop consensus guidelines for the design of large multicenter clinical trials. Twenty short presentations and discussions, summarized here, outlined the group's concerns and suggestions. Successful and failed, completed or ongoing, clinical studies provided insight as to endpoints that may be of value for future trauma and shock studies. In addition to the importance of appropriate endpoints in study design, other related topics were discussed, including trauma epidemiology, patient enrollment and inclusion criteria, community consultation and the difficulty of obtaining informed consent in acute trauma research, and the inclusion of quality of life in composite endpoints. The consensus was that more discussion was needed and that consideration of new endpoints for clinical trials in emergency trauma research was a worthwhile and necessary goal.

    Original languageEnglish (US)
    Pages (from-to)107-113
    Number of pages7
    JournalShock
    Volume35
    Issue number2
    DOIs
    StatePublished - Feb 2011

    Fingerprint

    Resuscitation
    Wounds and Injuries
    Research
    Clinical Trials
    Ethicists
    National Heart, Lung, and Blood Institute (U.S.)
    Hemorrhagic Shock
    Drug Industry
    Informed Consent
    Multicenter Studies
    Shock
    Epidemiology
    Emergencies
    Referral and Consultation
    Quality of Life
    Research Personnel
    Guidelines
    Physicians
    Mortality

    Keywords

    • 21CFR50.24
    • composite
    • endpoint
    • surrogate
    • Trauma

    ASJC Scopus subject areas

    • Critical Care and Intensive Care Medicine
    • Emergency Medicine

    Cite this

    Holcomb, J. B., Weiskopf, R., Champion, H., Gould, S. A., Sauer, R. M., Brasel, K., ... Wade, C. E. (2011). Challenges to effective research in acute trauma resuscitation: Consent and endpoints. Shock, 35(2), 107-113. https://doi.org/10.1097/SHK.0b013e3181f7fd01

    Challenges to effective research in acute trauma resuscitation : Consent and endpoints. / Holcomb, John B.; Weiskopf, Richard; Champion, Howard; Gould, Steven A.; Sauer, R. Michelle; Brasel, Karen; Bochicchio, Grant; Bulger, Eileen; Cotton, Bryan A.; Davis, Daniel; Dutton, Richard; Hauser, Carl J.; Hess, John R.; Hides, George A.; Knudson, Paula; MacKenzie, Ellen; McGinnis, Robert L.; Michalek, Joel; Moore, Frederick A.; Omert, Laurel; Pollock, Brad H.; Tortella, Bartholomew; Sugarman, Jeremy; Schreiber, Martin; Wade, Charles E.

    In: Shock, Vol. 35, No. 2, 02.2011, p. 107-113.

    Research output: Contribution to journalArticle

    Holcomb, JB, Weiskopf, R, Champion, H, Gould, SA, Sauer, RM, Brasel, K, Bochicchio, G, Bulger, E, Cotton, BA, Davis, D, Dutton, R, Hauser, CJ, Hess, JR, Hides, GA, Knudson, P, MacKenzie, E, McGinnis, RL, Michalek, J, Moore, FA, Omert, L, Pollock, BH, Tortella, B, Sugarman, J, Schreiber, M & Wade, CE 2011, 'Challenges to effective research in acute trauma resuscitation: Consent and endpoints', Shock, vol. 35, no. 2, pp. 107-113. https://doi.org/10.1097/SHK.0b013e3181f7fd01
    Holcomb, John B. ; Weiskopf, Richard ; Champion, Howard ; Gould, Steven A. ; Sauer, R. Michelle ; Brasel, Karen ; Bochicchio, Grant ; Bulger, Eileen ; Cotton, Bryan A. ; Davis, Daniel ; Dutton, Richard ; Hauser, Carl J. ; Hess, John R. ; Hides, George A. ; Knudson, Paula ; MacKenzie, Ellen ; McGinnis, Robert L. ; Michalek, Joel ; Moore, Frederick A. ; Omert, Laurel ; Pollock, Brad H. ; Tortella, Bartholomew ; Sugarman, Jeremy ; Schreiber, Martin ; Wade, Charles E. / Challenges to effective research in acute trauma resuscitation : Consent and endpoints. In: Shock. 2011 ; Vol. 35, No. 2. pp. 107-113.
    @article{cc73a7acbd4f446cb81e7f06f5c4ef84,
    title = "Challenges to effective research in acute trauma resuscitation: Consent and endpoints",
    abstract = "Selection of study endpoints is one of the most important decisions in the design of effective clinical trials. Late mortality (e.g., 28 days) is an unambiguous endpoint, accepted by regulatory agencies, but it is viewed as problematic among researchers in the study of resuscitation for acute trauma injury with hemorrhagic shock. In February 2008, physicians, ethicists, statisticians, and research scientists from the military, academia, industry, the Federal Drug Administration, and the National Heart Lung and Blood Institute gathered to discuss the obstacles confronting the trauma community in their efforts to improve patient outcomes. The primary meeting objective was to generate preliminary suggestions for a series of follow-up meetings that will develop consensus guidelines for the design of large multicenter clinical trials. Twenty short presentations and discussions, summarized here, outlined the group's concerns and suggestions. Successful and failed, completed or ongoing, clinical studies provided insight as to endpoints that may be of value for future trauma and shock studies. In addition to the importance of appropriate endpoints in study design, other related topics were discussed, including trauma epidemiology, patient enrollment and inclusion criteria, community consultation and the difficulty of obtaining informed consent in acute trauma research, and the inclusion of quality of life in composite endpoints. The consensus was that more discussion was needed and that consideration of new endpoints for clinical trials in emergency trauma research was a worthwhile and necessary goal.",
    keywords = "21CFR50.24, composite, endpoint, surrogate, Trauma",
    author = "Holcomb, {John B.} and Richard Weiskopf and Howard Champion and Gould, {Steven A.} and Sauer, {R. Michelle} and Karen Brasel and Grant Bochicchio and Eileen Bulger and Cotton, {Bryan A.} and Daniel Davis and Richard Dutton and Hauser, {Carl J.} and Hess, {John R.} and Hides, {George A.} and Paula Knudson and Ellen MacKenzie and McGinnis, {Robert L.} and Joel Michalek and Moore, {Frederick A.} and Laurel Omert and Pollock, {Brad H.} and Bartholomew Tortella and Jeremy Sugarman and Martin Schreiber and Wade, {Charles E.}",
    year = "2011",
    month = "2",
    doi = "10.1097/SHK.0b013e3181f7fd01",
    language = "English (US)",
    volume = "35",
    pages = "107--113",
    journal = "Shock",
    issn = "1073-2322",
    publisher = "Lippincott Williams and Wilkins",
    number = "2",

    }

    TY - JOUR

    T1 - Challenges to effective research in acute trauma resuscitation

    T2 - Consent and endpoints

    AU - Holcomb, John B.

    AU - Weiskopf, Richard

    AU - Champion, Howard

    AU - Gould, Steven A.

    AU - Sauer, R. Michelle

    AU - Brasel, Karen

    AU - Bochicchio, Grant

    AU - Bulger, Eileen

    AU - Cotton, Bryan A.

    AU - Davis, Daniel

    AU - Dutton, Richard

    AU - Hauser, Carl J.

    AU - Hess, John R.

    AU - Hides, George A.

    AU - Knudson, Paula

    AU - MacKenzie, Ellen

    AU - McGinnis, Robert L.

    AU - Michalek, Joel

    AU - Moore, Frederick A.

    AU - Omert, Laurel

    AU - Pollock, Brad H.

    AU - Tortella, Bartholomew

    AU - Sugarman, Jeremy

    AU - Schreiber, Martin

    AU - Wade, Charles E.

    PY - 2011/2

    Y1 - 2011/2

    N2 - Selection of study endpoints is one of the most important decisions in the design of effective clinical trials. Late mortality (e.g., 28 days) is an unambiguous endpoint, accepted by regulatory agencies, but it is viewed as problematic among researchers in the study of resuscitation for acute trauma injury with hemorrhagic shock. In February 2008, physicians, ethicists, statisticians, and research scientists from the military, academia, industry, the Federal Drug Administration, and the National Heart Lung and Blood Institute gathered to discuss the obstacles confronting the trauma community in their efforts to improve patient outcomes. The primary meeting objective was to generate preliminary suggestions for a series of follow-up meetings that will develop consensus guidelines for the design of large multicenter clinical trials. Twenty short presentations and discussions, summarized here, outlined the group's concerns and suggestions. Successful and failed, completed or ongoing, clinical studies provided insight as to endpoints that may be of value for future trauma and shock studies. In addition to the importance of appropriate endpoints in study design, other related topics were discussed, including trauma epidemiology, patient enrollment and inclusion criteria, community consultation and the difficulty of obtaining informed consent in acute trauma research, and the inclusion of quality of life in composite endpoints. The consensus was that more discussion was needed and that consideration of new endpoints for clinical trials in emergency trauma research was a worthwhile and necessary goal.

    AB - Selection of study endpoints is one of the most important decisions in the design of effective clinical trials. Late mortality (e.g., 28 days) is an unambiguous endpoint, accepted by regulatory agencies, but it is viewed as problematic among researchers in the study of resuscitation for acute trauma injury with hemorrhagic shock. In February 2008, physicians, ethicists, statisticians, and research scientists from the military, academia, industry, the Federal Drug Administration, and the National Heart Lung and Blood Institute gathered to discuss the obstacles confronting the trauma community in their efforts to improve patient outcomes. The primary meeting objective was to generate preliminary suggestions for a series of follow-up meetings that will develop consensus guidelines for the design of large multicenter clinical trials. Twenty short presentations and discussions, summarized here, outlined the group's concerns and suggestions. Successful and failed, completed or ongoing, clinical studies provided insight as to endpoints that may be of value for future trauma and shock studies. In addition to the importance of appropriate endpoints in study design, other related topics were discussed, including trauma epidemiology, patient enrollment and inclusion criteria, community consultation and the difficulty of obtaining informed consent in acute trauma research, and the inclusion of quality of life in composite endpoints. The consensus was that more discussion was needed and that consideration of new endpoints for clinical trials in emergency trauma research was a worthwhile and necessary goal.

    KW - 21CFR50.24

    KW - composite

    KW - endpoint

    KW - surrogate

    KW - Trauma

    UR - http://www.scopus.com/inward/record.url?scp=78751638853&partnerID=8YFLogxK

    UR - http://www.scopus.com/inward/citedby.url?scp=78751638853&partnerID=8YFLogxK

    U2 - 10.1097/SHK.0b013e3181f7fd01

    DO - 10.1097/SHK.0b013e3181f7fd01

    M3 - Article

    C2 - 20926987

    AN - SCOPUS:78751638853

    VL - 35

    SP - 107

    EP - 113

    JO - Shock

    JF - Shock

    SN - 1073-2322

    IS - 2

    ER -