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Volumn 25, Issue 3, 2011, Pages 352-356

Obtaining regulatory approval for multicentre randomised controlled trials: Experiences in the STICH II trial

Author keywords

CT scan; haemorrhage; Prospective randomised trial; surgery timing

Indexed keywords

BRAIN HEMORRHAGE; CONTRACT; GOVERNMENT REGULATION; MULTICENTER STUDY (TOPIC); PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); REGISTRATION; RESEARCH ETHICS; REVIEW;

EID: 79957587598     PISSN: 02688697     EISSN: 1360046X     Source Type: Journal    
DOI: 10.3109/02688697.2010.551675     Document Type: Review
Times cited : (10)

References (11)
  • 1
    • 33847253865 scopus 로고    scopus 로고
    • Surgical treatment of intracerebral haemorrhage
    • DOI 10.1097/MCC.0b013e3280a9e5c2, PII 0007519820070400000010
    • Mendelow AD, Unterberg A. Surgical treatment of intracerebral haemorrhage. Curr Opin Crit Care 2007;13:169-74 (Pubitemid 46328331)
    • (2007) Current Opinion in Critical Care , vol.13 , Issue.2 , pp. 169-174
    • Mendelow, A.D.1    Unterberg, A.2
  • 2
    • 13144256723 scopus 로고    scopus 로고
    • Early surgery versus initial conservative treatment in patients with spontaneous supratentorial intracerebral haematomas in the International Surgical Trial in Intracerebral Haemorrhage (STICH): A randomised trial
    • DOI 10.1016/S0140-6736(05)17826-X, PII S014067360517826X
    • Mendelow AD, Gregson BA, Fernandes HM, et al. Early surgery versus initial conservative treatment in patients with spontaneous supratentorial intracerebral haematomas in the International Surgical Trial in Intracerebral Haemorrhage (STICH): a randomised trial. Lancet 2005;365:387-97 (Pubitemid 40179225)
    • (2005) Lancet , vol.365 , Issue.9457 , pp. 387-397
    • Mendelow, A.D.1    Gregson, B.A.2    Fernandes, H.M.3    Murray, G.D.4    Teasdale, G.M.5    Terence Hope, D.6    Karimi, A.7    Shaw, M.D.M.8    Barer, D.H.9
  • 3
    • 2942512903 scopus 로고    scopus 로고
    • The revision of the Declaration of Helsinki: Past present and future
    • Carlson RV, Boyd KM, Webb DJ. The revision of the Declaration of Helsinki: past, present and future. BJCP 2004;57:696-713
    • (2004) BJCP , vol.57 , pp. 696-713
    • Carlson, R.V.1    Boyd, K.M.2    Webb, D.J.3
  • 4
    • 85047277976 scopus 로고    scopus 로고
    • The ethics of research ethics committees
    • Nicholl J. The ethics of research ethics committees. BMJ 2000;320:1217
    • (2000) BMJ , vol.320 , pp. 1217
    • Nicholl, J.1
  • 5
    • 2442671877 scopus 로고    scopus 로고
    • Another threat to research in the United Kingdom
    • Nicholson R. Another threat to research in the United Kingdom. BMJ 2004;328:1212-13 (Pubitemid 38686093)
    • (2004) British Medical Journal , vol.328 , Issue.7450 , pp. 1212-1213
    • Nicholson, R.1
  • 6
    • 0001820890 scopus 로고
    • An introduction to the law and economics of intellectual property
    • Besen SM, Raskind LJ. An introduction to the law and economics of intellectual property. JSTOR 1991;5:3-27
    • (1991) JSTOR , vol.5 , pp. 3-27
    • Besen, S.M.1    Raskind, L.J.2
  • 7
    • 0142260377 scopus 로고    scopus 로고
    • Legal standard of care: A shift from the traditional Bolam test
    • Samanta A, Samanta J. Legal standard of care: a shift from the traditional Bolam test. Clin Med 2003;3:443-6 (Pubitemid 37328462)
    • (2003) Clinical Medicine , vol.3 , Issue.5 , pp. 443-446
    • Samanta, A.1    Samanta, J.2
  • 9
    • 77950365089 scopus 로고    scopus 로고
    • European commission considers revisions to clinical trials directive
    • Mason E. European commission considers revisions to clinical trials directive. JNCI 2010:102:292-7
    • (2010) JNCI , vol.102 , pp. 292-297
    • Mason, E.1
  • 10
    • 79957625446 scopus 로고    scopus 로고
    • Regulations on medical research need to be reinterpreted not rewritten
    • Kmietowicz Z. Regulations on medical research need to be reinterpreted not rewritten. BMJ 2010;340:c.2732
    • (2010) BMJ , vol.340
    • Kmietowicz, Z.1
  • 11
    • 77950189829 scopus 로고    scopus 로고
    • Consort 2010 Statement: Updated guidelines for reporting parallel group randomised trials
    • for the CONSORT Group
    • Schulz KF, Altman DG, Moher D; for the CONSORT Group. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. BMJ 2010: 340;c332
    • (2010) BMJ , vol.340
    • Schulz, K.F.1    Altman, D.G.2    Moher, D.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.