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Volumn 16, Issue 1, 2015, Pages

Exploring the role and function of trial steering committees: Results of an expert panel meeting

(15)  Harman, Nicola L a   Conroy, Elizabeth J a   Lewis, Steff C b   Murray, Gordon b   Norrie, John c   Sydes, Matt R d,e   Lane, J Athene f   Altman, Douglas G g   Baigent, Colin g   Bliss, Judith M h   Campbell, Marion K i   Elbourne, Diana j   Evans, Stephen j   Sandercock, Peter b   Gamble, Carrol a  


Author keywords

Clinical trial; Data monitoring committee; Executive committee; Oversight committee; Randomised controlled trial; Terms of reference; Trial steering committee; Trials

Indexed keywords

CLINICAL ARTICLE; DNA TRANSCRIPTION; GENETIC TRANSCRIPTION; HUMAN; LIFESPAN; MEDICAL RESEARCH; PROFESSIONAL STANDARD; RESPONSIBILITY; UNCERTAINTY; ADVISORY COMMITTEE; CLINICAL TRIAL (TOPIC); CONFLICT OF INTEREST; CONSENSUS; CONSENSUS DEVELOPMENT; ECONOMICS; ETHICS; FINANCIAL MANAGEMENT; METHODOLOGY; ORGANIZATION AND MANAGEMENT; PERSONNEL; QUESTIONNAIRE; STANDARDS; STATISTICAL ANALYSIS; STATISTICS AND NUMERICAL DATA;

EID: 84953379166     PISSN: None     EISSN: 17456215     Source Type: Journal    
DOI: 10.1186/s13063-015-1125-z     Document Type: Article
Times cited : (23)

References (24)
  • 1
    • 0342282879 scopus 로고    scopus 로고
    • Accessed 28-12-2015.
    • Medical Research Council. Guidelines for good clinical practice in clinical trials 1998. http://www.mrc.ac.uk/documents/pdf/good-clinical-practice-in-clinical-trials/. Accessed 28-12-2015.
    • (1998) Guidelines for good clinical practice in clinical trials
  • 3
    • 13844318810 scopus 로고    scopus 로고
    • A proposed charter for clinical trial data monitoring committees: helping them to do their job well
    • DAMOCLES Study Group. A proposed charter for clinical trial data monitoring committees: helping them to do their job well. Lancet. 2005;365:711-22. doi: 10.1016/S0140-6736(05)17965-3.
    • (2005) Lancet , vol.365 , pp. 711-722
  • 4
    • 84947076569 scopus 로고    scopus 로고
    • Trial Steering Committees in randomised controlled trials: A survey of registered clinical trials units to establish current practice and experiences
    • Conroy EJ, Harman NL, Lane JA, Lewis SC, Murray G, Norrie J et al. Trial Steering Committees in randomised controlled trials: A survey of registered clinical trials units to establish current practice and experiences. Clinical Trials. 2015. doi: 10.1177/1740774515589959.
    • (2015) Clinical Trials
    • Conroy, E.J.1    Harman, N.L.2    Lane, J.A.3    Lewis, S.C.4    Murray, G.5    Norrie, J.6
  • 5
    • 4544333778 scopus 로고    scopus 로고
    • Systematic qualitative review of the literature on data monitoring committees for randomized controlled trials
    • Sydes MR, Spiegelhalter DJ, Altman DG, Babiker AB, Parmar MK, Group D. Systematic qualitative review of the literature on data monitoring committees for randomized controlled trials. Clin Trials. 2004;1:60-79. doi: 10.1191/1740774504cn004rr.
    • (2004) Clin Trials , vol.1 , pp. 60-79
    • Sydes, M.R.1    Spiegelhalter, D.J.2    Altman, D.G.3    Babiker, A.B.4    Parmar, M.K.5    Group, D.6
  • 6
    • 84953448967 scopus 로고    scopus 로고
    • Good Practice Principles for Sharing Individual Participant Data from Publicly Funded Clinical Trials
    • Accessed 28-12-2015.
    • Tudur Smith C HC, Sydes M, Woolfall K, Clarke M, Murray G, Williamson P. Good Practice Principles for Sharing Individual Participant Data from Publicly Funded Clinical Trials. 2015. http://www.methodologyhubs.mrc.ac.uk/files/7114/3682/3831/Datasharingguidance2015.pdf. Accessed 28-12-2015.
    • (2015)
    • Tudur Smith, C.H.C.1    Sydes, M.2    Woolfall, K.3    Clarke, M.4    Murray, G.5    Williamson, P.6
  • 7
    • 84953448968 scopus 로고    scopus 로고
    • Accessed 28-12-2015.
    • National Institute for Health Research Health Technology Assessment Programme. Research Governance Guidelines. 2012. http://www.nets.nihr.ac.uk/__data/assets/pdf_file/0010/77167/TSC_and_DMEC_Guidelines.pdf. Accessed 28-12-2015.
    • (2012) Research Governance Guidelines
  • 8
    • 84953398395 scopus 로고    scopus 로고
    • An ethnographic study of group decision making to understand and improve how trial steering committees contribute to trial conduct
    • Daykin A, Heawood A, Lane A, Macefield R, Gamble C, McCann S, et al. An ethnographic study of group decision making to understand and improve how trial steering committees contribute to trial conduct. Trials. 2013;14 Suppl 1:O79.
    • (2013) Trials , vol.14 , pp. O79
    • Daykin, A.1    Heawood, A.2    Lane, A.3    Macefield, R.4    Gamble, C.5    McCann, S.6
  • 9
    • 84953448969 scopus 로고    scopus 로고
    • The Medicines for Human Use (Clinical Trials) Regulations 2004. http://www.legislation.gov.uk/uksi/2004/1031/regulation/3/made. Accessed 28-12-2015.
    • (2004)
  • 10
    • 84855446160 scopus 로고    scopus 로고
    • Accessed 28-12-2015. second edition
    • Department of Health. Research governance framework for health and social care: second edition. 2005. https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/139565/dh_4122427.pdf. Accessed 28-12-2015.
    • (2005) Research governance framework for health and social care
  • 11
    • 0003663972 scopus 로고    scopus 로고
    • Accessed 28-12-2015.
    • ICH Harmonised Tripartite Guideline. Guideline for Good Clinical Practice E6 (R1) 1996. http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6/E6_R1_Guideline.pdf. Accessed 28-12-2015.
    • (1996) Guideline for Good Clinical Practice E6 (R1)
  • 12
    • 34249805427 scopus 로고    scopus 로고
    • When and How Can Endpoints Be Changed after Initiation of a Randomized Clinical Trial?
    • Evans S. When and How Can Endpoints Be Changed after Initiation of a Randomized Clinical Trial? PLoS Clin Trials. 2007;2:e18. doi: 10.1371/journal.pctr.0020018.
    • (2007) PLoS Clin Trials , vol.2 , pp. e18
    • Evans, S.1
  • 13
    • 0037108040 scopus 로고    scopus 로고
    • On changing a long-term clinical trial midstream
    • Wittes J. On changing a long-term clinical trial midstream. Stat Med. 2002;21:2789-95. doi: 10.1002/sim.1282.
    • (2002) Stat Med , vol.21 , pp. 2789-2795
    • Wittes, J.1
  • 14
    • 84908062023 scopus 로고    scopus 로고
    • Effect of nicotine patches in pregnancy on infant and maternal outcomes at 2 years: follow-up from the randomised, double-blind, placebo-controlled SNAP trial
    • Cooper S, Taggar J, Lewis S, Marlow N, Dickinson A, Whitemore R, et al. Effect of nicotine patches in pregnancy on infant and maternal outcomes at 2 years: follow-up from the randomised, double-blind, placebo-controlled SNAP trial. Lancet Respir Med. 2014;2:728-37. doi: 10.1016/S2213-2600(14)70157-2.
    • (2014) Lancet Respir Med , vol.2 , pp. 728-737
    • Cooper, S.1    Taggar, J.2    Lewis, S.3    Marlow, N.4    Dickinson, A.5    Whitemore, R.6
  • 15
    • 84908569444 scopus 로고    scopus 로고
    • Active monitoring, radical prostatectomy, or radiotherapy for localised prostate cancer: study design and diagnostic and baseline results of the ProtecT randomised phase 3 trial
    • Lane JA, Donovan JL, Davis M, Walsh E, Dedman D, Down L, et al. Active monitoring, radical prostatectomy, or radiotherapy for localised prostate cancer: study design and diagnostic and baseline results of the ProtecT randomised phase 3 trial. Lancet Oncol. 2014;15:1109-18. doi: 10.1016/S1470-2045(14)70361-4.
    • (2014) Lancet Oncol , vol.15 , pp. 1109-1118
    • Lane, J.A.1    Donovan, J.L.2    Davis, M.3    Walsh, E.4    Dedman, D.5    Down, L.6
  • 16
    • 84925124395 scopus 로고    scopus 로고
    • Telephone triage for management of same-day consultation requests in general practice (the ESTEEM trial): a cluster-randomised controlled trial and cost-consequence analysis
    • Campbell JL, Fletcher E, Britten N, Green C, Holt TA, Lattimer V et al. Telephone triage for management of same-day consultation requests in general practice (the ESTEEM trial): a cluster-randomised controlled trial and cost-consequence analysis. Lancet.2014;384:1859-68. doi: 10.1016/S0140-6736(14)61058-8.
    • (2014) Lancet , vol.384 , pp. 1859-1868
    • Campbell, J.L.1    Fletcher, E.2    Britten, N.3    Green, C.4    Holt, T.A.5    Lattimer, V.6
  • 17
    • 84919462085 scopus 로고    scopus 로고
    • Long-term clinical and cost-effectiveness of psychological intervention for family carers of people with dementia: a single-blind, randomised, controlled trial
    • Livingston G, Barber J, Rapaport P, Knapp M, Griffin M, King D et al. Long-term clinical and cost-effectiveness of psychological intervention for family carers of people with dementia: a single-blind, randomised, controlled trial. Lancet Psychiatry. 2014;1:539-48. doi: 10.1016/S2215-0366(14)00073-X.
    • (2014) Lancet Psychiatry , vol.1 , pp. 539-548
    • Livingston, G.1    Barber, J.2    Rapaport, P.3    Knapp, M.4    Griffin, M.5    King, D.6
  • 18
    • 84908345308 scopus 로고    scopus 로고
    • Long-term effectiveness of dopamine agonists and monoamine oxidase B inhibitors compared with levodopa as initial treatment for Parkinson's disease (PD MED): a large, open-label, pragmatic randomised trial
    • Pd Med Collaborative Group. Long-term effectiveness of dopamine agonists and monoamine oxidase B inhibitors compared with levodopa as initial treatment for Parkinson's disease (PD MED): a large, open-label, pragmatic randomised trial. Lancet. 2014;384:1196-205. doi: 10.1016/S0140-6736(14)60683-8.
    • (2014) Lancet , vol.384 , pp. 1196-1205
  • 19
    • 84919385144 scopus 로고    scopus 로고
    • Trials Collaboration. Effect of intermittent pneumatic compression on disability, living circumstances, quality of life, and hospital costs after stroke: secondary analyses from CLOTS 3, a randomised trial
    • CLOTS (Clots in Legs Or sTockings after Stroke) Trials Collaboration. Effect of intermittent pneumatic compression on disability, living circumstances, quality of life, and hospital costs after stroke: secondary analyses from CLOTS 3, a randomised trial. Lancet Neurol. 2014;13:1186-92. doi: 10.1016/S1474-4422(14)70258-3.
    • (2014) Lancet Neurol , vol.13 , pp. 1186-1192
  • 20
    • 84908025249 scopus 로고    scopus 로고
    • Continuous positive airway pressure in older people with obstructive sleep apnoea syndrome (PREDICT): a 12-month, multicentre, randomised trial
    • McMillan A, Bratton DJ, Faria R, Laskawiec-Szkonter M, Griffin S, Davies RJ et al. Continuous positive airway pressure in older people with obstructive sleep apnoea syndrome (PREDICT): a 12-month, multicentre, randomised trial. Lancet Respir Med. 2014;2:804-12. doi: 10.1016/S2213-2600(14)70172-9.
    • (2014) Lancet Respir Med , vol.2 , pp. 804-812
    • McMillan, A.1    Bratton, D.J.2    Faria, R.3    Laskawiec-Szkonter, M.4    Griffin, S.5    Davies, R.J.6
  • 21
    • 84953448970 scopus 로고    scopus 로고
    • Establishing a database of statistical expertise to support clinical trial oversight committees and develop capacity
    • Accessed 28-12-2015.
    • Establishing a database of statistical expertise to support clinical trial oversight committees and develop capacity 2013. http://www.methodologyhubs.mrc.ac.uk/research/network-projects#block2013-06 Accessed 28-12-2015.
    • (2013)
  • 22
    • 84977177146 scopus 로고    scopus 로고
    • Trial steering committees for randomised controlled trials: updating and redeveloping guidance and terms of reference informed by current practice and experience
    • Conroy E, Lewis S, Lane A, Sydes M, Norrie J, Murray G, et al. Trial steering committees for randomised controlled trials: updating and redeveloping guidance and terms of reference informed by current practice and experience. Trials. 2013;14 Suppl 1:128.
    • (2013) Trials , vol.14 , pp. 128
    • Conroy, E.1    Lewis, S.2    Lane, A.3    Sydes, M.4    Norrie, J.5    Murray, G.6
  • 23
    • 84920518117 scopus 로고    scopus 로고
    • From plans to actions in patient and public involvement: qualitative study of documented plans and the accounts of researchers and patients sampled from a cohort of clinical trials
    • Buck D, Gamble C, Dudley L, Preston J, Hanley B, Williamson PR, et al. From plans to actions in patient and public involvement: qualitative study of documented plans and the accounts of researchers and patients sampled from a cohort of clinical trials. BMJ Open. 2014;4:e006400. doi: 10.1136/bmjopen-2014-006400.
    • (2014) BMJ Open , vol.4 , pp. e006400
    • Buck, D.1    Gamble, C.2    Dudley, L.3    Preston, J.4    Hanley, B.5    Williamson, P.R.6
  • 24
    • 84936886887 scopus 로고    scopus 로고
    • What Difference Does Patient and Public Involvement Make and What Are Its Pathways to Impact? Qualitative Study of Patients and Researchers from a Cohort of Randomised Clinical Trials
    • Dudley L, Gamble C, Preston J, Buck D, Hanley B, Williamson P, et al. What Difference Does Patient and Public Involvement Make and What Are Its Pathways to Impact? Qualitative Study of Patients and Researchers from a Cohort of Randomised Clinical Trials. PLoS One. 2015;10:e0128817. doi: 10.1371/journal.pone.0128817.
    • (2015) PLoS One , vol.10 , pp. e0128817
    • Dudley, L.1    Gamble, C.2    Preston, J.3    Buck, D.4    Hanley, B.5    Williamson, P.6


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