메뉴 건너뛰기




Volumn 47, Issue 2, 2013, Pages 152-160

Cycle Time Metrics for Multisite Clinical Trials in the United States

Author keywords

metrics; study start up; trials

Indexed keywords

ARTICLE; BIOTECHNOLOGY; DEMOGRAPHY; INFORMED CONSENT; MEDICAL RESEARCH; MULTICENTER STUDY (TOPIC); PRIORITY JOURNAL; RESEARCH SUBJECT; STANDARD; STATISTICAL ANALYSIS; TIME; UNITED STATES;

EID: 84877589607     PISSN: 21684790     EISSN: 21649200     Source Type: Journal    
DOI: None     Document Type: Article
Times cited : (16)

References (31)
  • 2
    • 84855468385 scopus 로고    scopus 로고
    • The importance of doing trials right while doing the right trials
    • Dilts D,Cheng SK.The importance of doing trials right while doing the right trials.Clin Cancer Res. 2012;18 (1): 3-5.
    • (2012) Clin Cancer Res , vol.18 , Issue.1 , pp. 3-5
    • Dilts, D.1    Cheng, S.K.2
  • 3
    • 0037433442 scopus 로고    scopus 로고
    • Central challenges facing the national clinical research enterprise
    • Sung NS,Crowley WF,Genel M, et al.Central challenges facing the national clinical research enterprise.JAMA. 2003;289 (10): 1278-1287.
    • (2003) JAMA , vol.289 , Issue.10 , pp. 1278-1287
    • Sung, N.S.1    Crowley, W.F.2    Genel, M.3
  • 4
    • 60849106348 scopus 로고    scopus 로고
    • Ethical and scientific implications of the globalization of clinical research
    • Glickman SW,McHutchison JG,Peterson ED, et al.Ethical and scientific implications of the globalization of clinical research.N Engl J Med. 2009;360 (8): 816-823.
    • (2009) N Engl J Med , vol.360 , Issue.8 , pp. 816-823
    • Glickman, S.W.1    McHutchison, J.G.2    Peterson, E.D.3
  • 5
    • 79961183552 scopus 로고    scopus 로고
    • International participation in cardiovascular randomized controlled trials sponsored by the National Heart, Lung, and Blood Institute
    • Kim ES,Carrigan TP,Menon V.International participation in cardiovascular randomized controlled trials sponsored by the National Heart, Lung, and Blood Institute.J Am Coll Cardiol. 2011;58 (7): 671-676.
    • (2011) J Am Coll Cardiol , vol.58 , Issue.7 , pp. 671-676
    • Kim, E.S.1    Carrigan, T.P.2    Menon, V.3
  • 6
    • 79961187813 scopus 로고    scopus 로고
    • American industry and the U.S. Cardiovascular Clinical Research Enterprise an appropriate analogy?
    • Califf RM,Harrington RA.American industry and the U.S. Cardiovascular Clinical Research Enterprise an appropriate analogy?.J Am Coll Cardiol. 2011;58 (7): 677-680.
    • (2011) J Am Coll Cardiol , vol.58 , Issue.7 , pp. 677-680
    • Califf, R.M.1    Harrington, R.A.2
  • 7
    • 84860444921 scopus 로고    scopus 로고
    • Characteristics of clinical trials registered in Clinical Trials.gov, 2007-2010
    • Califf RM,Zarin DA,Kramer JM,Sherman RE,Aberle LH,Tasneem A.Characteristics of clinical trials registered in Clinical Trials.gov, 2007-2010.JAMA. 2012;307 (17): 1838-1847.
    • (2012) JAMA , vol.307 , Issue.17 , pp. 1838-1847
    • Califf, R.M.1    Zarin, D.A.2    Kramer, J.M.3    Sherman, R.E.4    Aberle, L.H.5    Tasneem, A.6
  • 8
    • 79954508843 scopus 로고    scopus 로고
    • A systematic review of the empirical literature evaluating IRBs: what we know and what we still need to learn
    • Abbott L,Grady C.A systematic review of the empirical literature evaluating IRBs: what we know and what we still need to learn.J Empir Res Hum Res Ethics. 2011;6 (1): 3-19.
    • (2011) J Empir Res Hum Res Ethics , vol.6 , Issue.1 , pp. 3-19
    • Abbott, L.1    Grady, C.2
  • 9
    • 84943709252 scopus 로고
    • Use of ranks in one-criterion variance analysis
    • Kruskal WH,Wallis WA.Use of ranks in one-criterion variance analysis.J Am Stat Assoc. 1952;47 (260): 583-621.
    • (1952) J Am Stat Assoc , vol.47 , Issue.260 , pp. 583-621
    • Kruskal, W.H.1    Wallis, W.A.2
  • 10
    • 78651341094 scopus 로고    scopus 로고
    • Analysis of overall level of evidence behind Infectious Diseases Society of America practice guidelines
    • Lee DH,Vielemeyer O.Analysis of overall level of evidence behind Infectious Diseases Society of America practice guidelines.Ann Intern Med. 2011;171:18-22.
    • (2011) Ann Intern Med , vol.171 , pp. 18-22
    • Lee, D.H.1    Vielemeyer, O.2
  • 11
    • 61449263596 scopus 로고    scopus 로고
    • Scientific evidence underlying the ACC/AHA clinical practice guidelines
    • Tricoci P,Allen JM,Kramer JM,Califf RM,Smith SC.Scientific evidence underlying the ACC/AHA clinical practice guidelines.JAMA. 2009;301 (8): 831-841.
    • (2009) JAMA , vol.301 , Issue.8 , pp. 831-841
    • Tricoci, P.1    Allen, J.M.2    Kramer, J.M.3    Califf, R.M.4    Smith, S.C.5
  • 12
    • 0037072462 scopus 로고    scopus 로고
    • Lessons learned from recent cardiovascular clinical trials: part I
    • DeMets D,Califf R.Lessons learned from recent cardiovascular clinical trials: part I.Circulation. 2002;106:746-751.
    • (2002) Circulation , vol.106 , pp. 746-751
    • DeMets, D.1    Califf, R.2
  • 13
    • 70349860152 scopus 로고    scopus 로고
    • Reasons for resubmission of research projects to the research ethics committee of a university hospital in São Paulo, Brazil
    • Bueno M,Brevidelli MM,Cocarelli T,Santos GM,Ferraz MA,Mion D.Reasons for resubmission of research projects to the research ethics committee of a university hospital in São Paulo, Brazil.Clinics (Sao Paulo). 2009;64 (9): 831-836.
    • (2009) Clinics (Sao Paulo) , vol.64 , Issue.9 , pp. 831-836
    • Bueno, M.1    Brevidelli, M.M.2    Cocarelli, T.3    Santos, G.M.4    Ferraz, M.A.5    Mion, D.6
  • 14
    • 77955626801 scopus 로고    scopus 로고
    • Time spent for activation of non-profit studies in oncology in Italy
    • De Feo G,Signoriello S,Bryce JC, et al.Time spent for activation of non-profit studies in oncology in Italy.PLoS One. 2010;5 (7): e11864.
    • (2010) PLoS One , vol.5 , Issue.7
    • de Feo, G.1    Signoriello, S.2    Bryce, J.C.3
  • 15
    • 33750591807 scopus 로고    scopus 로고
    • Invisible barriers to clinical trials: the impact of structural, infrastructural, and procedural barriers to opening oncology clinical trials
    • Dilts DM,Sandler AB.Invisible barriers to clinical trials: the impact of structural, infrastructural, and procedural barriers to opening oncology clinical trials.J Clin Oncol. 2006;24 (28): 4545-4552.
    • (2006) J Clin Oncol , vol.24 , Issue.28 , pp. 4545-4552
    • Dilts, D.M.1    Sandler, A.B.2
  • 16
    • 33750585093 scopus 로고    scopus 로고
    • Processes to activate phase III clinical trials in a cooperative oncology group: the case of cancer and leukemia group B
    • Dilts DM,Sandler AB,Baker M, et al.Processes to activate phase III clinical trials in a cooperative oncology group: the case of cancer and leukemia group B.J Clin Oncol. 2006;24 (28): 4553-4557.
    • (2006) J Clin Oncol , vol.24 , Issue.28 , pp. 4553-4557
    • Dilts, D.M.1    Sandler, A.B.2    Baker, M.3
  • 17
    • 50349099021 scopus 로고    scopus 로고
    • Development of clinical trials in a cooperative group setting: the eastern cooperative oncology group
    • DiltsDM, Sandler A,Cheng S, et al.Development of clinical trials in a cooperative group setting: the eastern cooperative oncology group.Clin Cancer Res. 2008;14 (11): 3427-3433.
    • (2008) Clin Cancer Res , vol.14 , Issue.11 , pp. 3427-3433
    • Dilts, D.M.1    Sandler, A.2    Cheng, S.3
  • 18
    • 64649092129 scopus 로고    scopus 로고
    • Steps and time to process clinical trials at the Cancer Therapy Evaluation Program
    • Dilts DM,Sandler AB,Cheng SK, et al.Steps and time to process clinical trials at the Cancer Therapy Evaluation Program.J Clin Oncol. 2009;27 (11): 1761-1766.
    • (2009) J Clin Oncol , vol.27 , Issue.11 , pp. 1761-1766
    • Dilts, D.M.1    Sandler, A.B.2    Cheng, S.K.3
  • 20
    • 33646168992 scopus 로고    scopus 로고
    • Regulatory challenges: lessons from recent West Nile virus trials in the United States
    • Jester PM,Tilden SJ,Li Y,Whitley RJ,Sullender WM.Regulatory challenges: lessons from recent West Nile virus trials in the United States.Contemp Clin Trials. 2006;27 (3): 254-259.
    • (2006) Contemp Clin Trials , vol.27 , Issue.3 , pp. 254-259
    • Jester, P.M.1    Tilden, S.J.2    Li, Y.3    Whitley, R.J.4    Sullender, W.M.5
  • 21
    • 77956247583 scopus 로고    scopus 로고
    • Time to activate lung cancer clinical trials and patient enrollment: a representative comparison study between two academic centers across the Atlantic
    • Wang-Gillam A,Williams K,Novello S,Gao F,Scagliotti GV,Govindan R.Time to activate lung cancer clinical trials and patient enrollment: a representative comparison study between two academic centers across the Atlantic.J Clin Oncol. 2010;28 (24): 3803-3807.
    • (2010) J Clin Oncol , vol.28 , Issue.24 , pp. 3803-3807
    • Wang-Gillam, A.1    Williams, K.2    Novello, S.3    Gao, F.4    Scagliotti, G.V.5    Govindan, R.6
  • 22
    • 0038369243 scopus 로고    scopus 로고
    • The effects of local review on informed consent documents from a multicenter clinical trials consortium
    • Burman W,Breese P,Weis S,Bock N,Bernardo J,Vernon A.The effects of local review on informed consent documents from a multicenter clinical trials consortium.Control Clin Trials. 2003;24 (3): 245-255.
    • (2003) Control Clin Trials , vol.24 , Issue.3 , pp. 245-255
    • Burman, W.1    Breese, P.2    Weis, S.3    Bock, N.4    Bernardo, J.5    Vernon, A.6
  • 23
    • 13644266883 scopus 로고    scopus 로고
    • Variations among Institutional Review Board reviews in a multisite health services research study
    • Dziak K,Anderson R,Sevick MA,Weisman CS,Levine DW,Scholle SH.Variations among Institutional Review Board reviews in a multisite health services research study.Health Serv Res. 2005;40 (1): 279-290.
    • (2005) Health Serv Res , vol.40 , Issue.1 , pp. 279-290
    • Dziak, K.1    Anderson, R.2    Sevick, M.A.3    Weisman, C.S.4    Levine, D.W.5    Scholle, S.H.6
  • 24
    • 71549167992 scopus 로고    scopus 로고
    • Effects of local institutional review board review on participation in national practice-based research network studies
    • Finch SA,Barkin SL,Wasserman RC,Dhepyasuwan N,Slora EJ,Sege RD.Effects of local institutional review board review on participation in national practice-based research network studies.Arch Pediatr Adolesc Med. 2009;163 (12): 1130-1134.
    • (2009) Arch Pediatr Adolesc Med , vol.163 , Issue.12 , pp. 1130-1134
    • Finch, S.A.1    Barkin, S.L.2    Wasserman, R.C.3    Dhepyasuwan, N.4    Slora, E.J.5    Sege, R.D.6
  • 25
    • 13644256038 scopus 로고    scopus 로고
    • Institutional review boards and multisite studies in health services research: is there a better way?
    • Gold JL,Dewa CS.Institutional review boards and multisite studies in health services research: is there a better way?.Health Serv Res. 2005;40 (1): 291-307.
    • (2005) Health Serv Res , vol.40 , Issue.1 , pp. 291-307
    • Gold, J.L.1    Dewa, C.S.2
  • 26
    • 33644928770 scopus 로고    scopus 로고
    • Impact of institutional review board practice variation on observational health services research
    • Green LA,Lowery JC,Kowalski CP,Wyszewianski L.Impact of institutional review board practice variation on observational health services research.Health Serv Res. 2006;41 (1): 214-230.
    • (2006) Health Serv Res , vol.41 , Issue.1 , pp. 214-230
    • Green, L.A.1    Lowery, J.C.2    Kowalski, C.P.3    Wyszewianski, L.4
  • 27
    • 33745662181 scopus 로고    scopus 로고
    • A review finds that multicenter studies face substantial challenges but strategies exist to achieve Institutional Review Board approval
    • Greene SM,Geiger AM.A review finds that multicenter studies face substantial challenges but strategies exist to achieve Institutional Review Board approval.J Clin Epidemiol. 2006;59 (8): 784-790.
    • (2006) J Clin Epidemiol , vol.59 , Issue.8 , pp. 784-790
    • Greene, S.M.1    Geiger, A.M.2
  • 28
    • 33947509950 scopus 로고    scopus 로고
    • Variation in institutional review board responses to a standard, observational, pediatric research protocol
    • Mansbach J,Acholonu U,Clark S,Camargo CA.Variation in institutional review board responses to a standard, observational, pediatric research protocol.Acad Emerg Med. 2007;14 (4): 377-380.
    • (2007) Acad Emerg Med , vol.14 , Issue.4 , pp. 377-380
    • Mansbach, J.1    Acholonu, U.2    Clark, S.3    Camargo, C.A.4
  • 29
    • 22844433910 scopus 로고    scopus 로고
    • Institutional variability in a minimal risk, population-based study: recognizing policy barriers to health services research
    • Newgard CD,Hui SH,Stamps-White P,Lewis RJ.Institutional variability in a minimal risk, population-based study: recognizing policy barriers to health services research.Health Serv Res. 2005;40 (4): 1247-1258.
    • (2005) Health Serv Res , vol.40 , Issue.4 , pp. 1247-1258
    • Newgard, C.D.1    Hui, S.H.2    Stamps-White, P.3    Lewis, R.J.4
  • 30
    • 0034988768 scopus 로고    scopus 로고
    • Variation in institutional review board responses to a standard protocol for a multicenter clinical trial
    • Stair TO,Reed CR,Radeos MS,Koski G,Camargo CA.Variation in institutional review board responses to a standard protocol for a multicenter clinical trial.Acad Emerg Med. 2001;8 (6): 636-641.
    • (2001) Acad Emerg Med , vol.8 , Issue.6 , pp. 636-641
    • Stair, T.O.1    Reed, C.R.2    Radeos, M.S.3    Koski, G.4    Camargo, C.A.5
  • 31
    • 77649186879 scopus 로고    scopus 로고
    • Variation among institutional review boards in evaluating the design of a multicenter randomized trial
    • Stark AR,Tyson JE,Hibberd PL.Variation among institutional review boards in evaluating the design of a multicenter randomized trial.J Perinatol. 2010;30 (3): 163-169.
    • (2010) J Perinatol , vol.30 , Issue.3 , pp. 163-169
    • Stark, A.R.1    Tyson, J.E.2    Hibberd, P.L.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.