References
Journal articles
The series of articles 'Trials on Trial' by Gebski, Keech and colleagues in the Medical Journal of Australia are available via electronic access here.
This material, expanded with new material and examples, is
covered in the book,
Interpreting and reporting clinical trials,
available from the Medical Journal of Australia shop.
Relevant articles include:
Beller EM, Gebski VJ, Keech AC. Randomisation in clinical
trials.
Medical Journal of Australia 2002; 177(10): 565-7.
Brighton J, Keech AC, Gebski VJ. Specifying interventions in
a clinical trial.
Medical Journal of Australia 2002; 176: 491-2.
Burgess DC, Gebski VJ, Keech AC. Baseline data in clinical
trials.
Medical Journal of Australia 2003; 179(2): 105-7.
Cakir B, Gebski VJ, Keech AC. Flow of participants in
randomised studies.
Medical Journal of Australia 2003; 178(7): 347-9.
Cook DI, Gebski VJ, Keech AC. Subgroup analysis in clinical
trials.
Medical Journal of Australia 2004; 180(6): 289-91.
Gebski VJ, Beller E, Keech AC. Randomised controlled trials:
elements of a good study.
Medical Journal of Australia 2001; 175: 272-6.
Gebski VJ, Marschner I, Keech AC. Specifying objectives and
outcomes for clinical trials.
Medical Journal of Australia 2002; 176: 491-2.
Gebski VJ, Keech AC. Statistical methods in clinical trials.
Medical Journal of Australia 2003; 178(4): 182-3.
Ghersi D, Gebski VJ, Keech AC. Scientific background and
rationale for a randomised controlled trial.
Medical Journal of Australia 2001;
175: 386-7.
Hague W, Gebski VJ, Keech AC. Recruitment to randomised
studies.
Medical Journal of Australia 2003; 178(11): 579-81.
Heritier SR, Gebski VJ, Keech AC. Inclusion of patients in clinical trial analysis: the intention-to-treat principle. Medical Journal of Australia 2003; 179(8): 438-40.
Keech AC, Gebski VJ. Selecting participants for clinical
trials.
Medical Journal of Australia 2001; 9(175): 490-3.
Keech AC, Gebski VJ. Managing the resource demands of a
large sample size in clinical trials: can you succeed with few subjects?
Medical Journal of Australia 2002; 177(8): 445-7.
Kirby A, Gebski VJ, Keech AC. Sample size in a clinical
trial.
Medical Journal of Australia 2002; 177: 256-7.
O'Connell R, Gebski VJ, Keech AC. Making sense of trial
results: outcomes and estimation.
Medical Journal of Australia 2003; 180:
128-30.
Lord SJ, Gebski VJ, Keech AC. Multiple analyses in clinical
trials: sound science or data dredging.
Medical Journal of Australia 2004;
181(8): 452–454.
Simes RJ, Gebski VJ, Keech AC. Subgroup analysis:
application to individual patient decisions.
Medical Journal of Australia 2004;
180(9): 467-9.
Seale JP, Gebski VJ, Keech AC. Generalising the results of
trials to clinical practice.
Medical Journal of Australia 2004; 181(10):
558–560.
Keech AC, Wonders SM, Cook DI, Gebski VJ. Balancing the
outcomes: reporting adverse events.
Medical Journal of Australia 2004; 181(4):
215–218.
Cook DI, Gebski VJ, Keech AC. Subgroup analysis in clinical
trials.
Medical Journal of Australia 2004; 180: 289–291.
Forder PM, Gebski VJ, Keech AC. Allocation concealment and
blinding: when ignorance is bliss.
Medical Journal of Australia 2005; 182(2):
87–89.
Other journal articles that may be useful include:
Schulz KF, Grimes DA. Generation of allocation sequences in
randomised trials: chance, not choice.
Lancet 2002; 359: 515-519
Schulz KF, Grimes DA. Allocation concealment in randomised
trials: defending against deciphering.
Lancet 2002; 359: 614-618
Schulz KF, Grimes DA. Blinding in randomised trials: hiding
who got what.
Lancet 2002; 359: 696-700
Schulz KF, Grimes DA. Sample size calculations in randomised
trials: mandatory and mystical.
Lancet 2005; 365: 1348-53.
Schulz KF, Grimes DA. Multiplicity in randomised trials I:
endpoints and treatments.
Lancet 2005; 365: 1591-95.
Schulz KF, Grimes DA. Multiplicity in randomised trials II:
subgroup and interim analyses.
Lancet 2005; 365: 1657-61.
Altman DG, Schulz KF, Moher D, et al., for the CONSORT
Group. The CONSORT statement: revised recommendations for improving the quality
of reports of parallel-group randomized trials.
Annals of Internal Medicine
2001; 134(8): 657–662.
Altman DG, Schulz KF, Moher D, et al., for the CONSORT
Group. The revised CONSORT statement for reporting randomized trials:
explanation and elaboration.
Annals of Internal Medicine 2001; 134(8):
663–694.
Grimes DA, Hubacher D, Nanda K, Schulz KF, Moher D, Altman
DG. The Good Clinical Practice guideline: a bronze standard for clinical
research.
Lancet 2005; 366: 172–74
