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- Altman D. G., Doré C. J. Randomisation and baseline comparisons in clinical trials. Lancet. 1990 Jan 20;335(8682):149–153. doi: 10.1016/0140-6736(90)90014-v. [DOI] [PubMed] [Google Scholar]
- Altman D. G., Schulz K. F. Statistics notes: Concealing treatment allocation in randomised trials. BMJ. 2001 Aug 25;323(7310):446–447. doi: 10.1136/bmj.323.7310.446. [DOI] [PMC free article] [PubMed] [Google Scholar]
- Assmann S. F., Pocock S. J., Enos L. E., Kasten L. E. Subgroup analysis and other (mis)uses of baseline data in clinical trials. Lancet. 2000 Mar 25;355(9209):1064–1069. doi: 10.1016/S0140-6736(00)02039-0. [DOI] [PubMed] [Google Scholar]
- Bath F. J., Owen V. E., Bath P. M. Quality of full and final publications reporting acute stroke trials: a systematic review. Stroke. 1998 Oct;29(10):2203–2210. doi: 10.1161/01.str.29.10.2203. [DOI] [PubMed] [Google Scholar]
- Bekelman Justin E., Li Yan, Gross Cary P. Scope and impact of financial conflicts of interest in biomedical research: a systematic review. JAMA. 2003 Jan 22;289(4):454–465. doi: 10.1001/jama.289.4.454. [DOI] [PubMed] [Google Scholar]
- Bucher H. C., Guyatt G. H., Cook D. J., Holbrook A., McAlister F. A. Users' guides to the medical literature: XIX. Applying clinical trial results. A. How to use an article measuring the effect of an intervention on surrogate end points. Evidence-Based Medicine Working Group. JAMA. 1999 Aug 25;282(8):771–778. doi: 10.1001/jama.282.8.771. [DOI] [PubMed] [Google Scholar]
- Clarke M., Halsey J. DICE 2: a further investigation of the effects of chance in life, death and subgroup analyses. Int J Clin Pract. 2001 May;55(4):240–242. [PubMed] [Google Scholar]
- Collins R., MacMahon S. Reliable assessment of the effects of treatment on mortality and major morbidity, I: clinical trials. Lancet. 2001 Feb 3;357(9253):373–380. doi: 10.1016/S0140-6736(00)03651-5. [DOI] [PubMed] [Google Scholar]
- Cuervo Luis Gabriel, Clarke Mike. Balancing benefits and harms in health care. BMJ. 2003 Jul 12;327(7406):65–66. doi: 10.1136/bmj.327.7406.65. [DOI] [PMC free article] [PubMed] [Google Scholar]
- Donnan Geoffrey A., Davis Stephen M., Kaste Markku, International Trial Subcommittee of the International Stroke Liaison Committee, American Stroke Association Recommendations for the relationship between sponsors and investigators in the design and conduct of clinical stroke trials. Stroke. 2003 Mar 20;34(4):1041–1045. doi: 10.1161/01.STR.0000063142.39828.67. [DOI] [PubMed] [Google Scholar]
- Ebbutt A. F., Frith L. Practical issues in equivalence trials. Stat Med. 1998 Aug 15;17(15-16):1691–1701. doi: 10.1002/(sici)1097-0258(19980815/30)17:15/16<1691::aid-sim971>3.0.co;2-j. [DOI] [PubMed] [Google Scholar]
- Fergusson Dean, Aaron Shawn D., Guyatt Gordon, Hébert Paul. Post-randomisation exclusions: the intention to treat principle and excluding patients from analysis. BMJ. 2002 Sep 21;325(7365):652–654. doi: 10.1136/bmj.325.7365.652. [DOI] [PMC free article] [PubMed] [Google Scholar]
- Fleming T. R., DeMets D. L. Surrogate end points in clinical trials: are we being misled? Ann Intern Med. 1996 Oct 1;125(7):605–613. doi: 10.7326/0003-4819-125-7-199610010-00011. [DOI] [PubMed] [Google Scholar]
- Glynn R. J., Buring J. E. Ways of measuring rates of recurrent events. BMJ. 1996 Feb 10;312(7027):364–367. doi: 10.1136/bmj.312.7027.364. [DOI] [PMC free article] [PubMed] [Google Scholar]
- Goodman S. N., Berlin J. A. The use of predicted confidence intervals when planning experiments and the misuse of power when interpreting results. Ann Intern Med. 1994 Aug 1;121(3):200–206. doi: 10.7326/0003-4819-121-3-199408010-00008. [DOI] [PubMed] [Google Scholar]
- Jones B., Jarvis P., Lewis J. A., Ebbutt A. F. Trials to assess equivalence: the importance of rigorous methods. BMJ. 1996 Jul 6;313(7048):36–39. doi: 10.1136/bmj.313.7048.36. [DOI] [PMC free article] [PubMed] [Google Scholar]
- Kernan W. N., Viscoli C. M., Makuch R. W., Brass L. M., Horwitz R. I. Stratified randomization for clinical trials. J Clin Epidemiol. 1999 Jan;52(1):19–26. doi: 10.1016/s0895-4356(98)00138-3. [DOI] [PubMed] [Google Scholar]
- Kerry S. M., Bland J. M. Trials which randomize practices I: how should they be analysed? Fam Pract. 1998 Feb;15(1):80–83. doi: 10.1093/fampra/15.1.80. [DOI] [PubMed] [Google Scholar]
- Kidwell C. S., Liebeskind D. S., Starkman S., Saver J. L. Trends in acute ischemic stroke trials through the 20th century. Stroke. 2001 Jun;32(6):1349–1359. doi: 10.1161/01.str.32.6.1349. [DOI] [PubMed] [Google Scholar]
- Lewis S., Clarke M. Forest plots: trying to see the wood and the trees. BMJ. 2001 Jun 16;322(7300):1479–1480. doi: 10.1136/bmj.322.7300.1479. [DOI] [PMC free article] [PubMed] [Google Scholar]
- Lexchin Joel, Bero Lisa A., Djulbegovic Benjamin, Clark Otavio. Pharmaceutical industry sponsorship and research outcome and quality: systematic review. BMJ. 2003 May 31;326(7400):1167–1170. doi: 10.1136/bmj.326.7400.1167. [DOI] [PMC free article] [PubMed] [Google Scholar]
- Lubsen Jacobus, Kirwan Bridget-Anne. Combined endpoints: can we use them? Stat Med. 2002 Oct 15;21(19):2959–2970. doi: 10.1002/sim.1300. [DOI] [PubMed] [Google Scholar]
- Mann Jeffrey. Truths about the NINDS study: setting the record straight. West J Med. 2002 May;176(3):192–194. doi: 10.1136/ewjm.176.3.192. [DOI] [PMC free article] [PubMed] [Google Scholar]
- Matthews J. N., Altman D. G., Campbell M. J., Royston P. Analysis of serial measurements in medical research. BMJ. 1990 Jan 27;300(6719):230–235. doi: 10.1136/bmj.300.6719.230. [DOI] [PMC free article] [PubMed] [Google Scholar]
- Matthews J. N., Altman D. G. Interaction 3: How to examine heterogeneity. BMJ. 1996 Oct 5;313(7061):862–862. doi: 10.1136/bmj.313.7061.862. [DOI] [PMC free article] [PubMed] [Google Scholar]
- Moher D., Schulz K. F., Altman D., CONSORT Group (Consolidated Standards of Reporting Trials) The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials. JAMA. 2001 Apr 18;285(15):1987–1991. doi: 10.1001/jama.285.15.1987. [DOI] [PubMed] [Google Scholar]
- Noseworthy J. H., Ebers G. C., Vandervoort M. K., Farquhar R. E., Yetisir E., Roberts R. The impact of blinding on the results of a randomized, placebo-controlled multiple sclerosis clinical trial. Neurology. 1994 Jan;44(1):16–20. doi: 10.1212/wnl.44.1.16. [DOI] [PubMed] [Google Scholar]
- Pocock Stuart J., Assmann Susan E., Enos Laura E., Kasten Linda E. Subgroup analysis, covariate adjustment and baseline comparisons in clinical trial reporting: current practice and problems. Stat Med. 2002 Oct 15;21(19):2917–2930. doi: 10.1002/sim.1296. [DOI] [PubMed] [Google Scholar]
- Roberts C., Torgerson D. Randomisation methods in controlled trials. BMJ. 1998 Nov 7;317(7168):1301–1301. doi: 10.1136/bmj.317.7168.1301. [DOI] [PMC free article] [PubMed] [Google Scholar]
- Schulz Kenneth F., Chalmers Iain, Altman Douglas G. The landscape and lexicon of blinding in randomized trials. Ann Intern Med. 2002 Feb 5;136(3):254–259. doi: 10.7326/0003-4819-136-3-200202050-00022. [DOI] [PubMed] [Google Scholar]
- Schulz Kenneth F., Grimes David A. Allocation concealment in randomised trials: defending against deciphering. Lancet. 2002 Feb 16;359(9306):614–618. doi: 10.1016/S0140-6736(02)07750-4. [DOI] [PubMed] [Google Scholar]
- Schulz Kenneth F., Grimes David A. Sample size slippages in randomised trials: exclusions and the lost and wayward. Lancet. 2002 Mar 2;359(9308):781–785. doi: 10.1016/S0140-6736(02)07882-0. [DOI] [PubMed] [Google Scholar]
- Warlow Charles. Advanced issues in the design and conduct of randomized clinical trials: the bigger the better? Stat Med. 2002 Oct 15;21(19):2797–2805. doi: 10.1002/sim.1283. [DOI] [PubMed] [Google Scholar]
- Wheatley Keith, Clayton David. Be skeptical about unexpected large apparent treatment effects: the case of an MRC AML12 randomization. Control Clin Trials. 2003 Feb;24(1):66–70. doi: 10.1016/s0197-2456(02)00273-8. [DOI] [PubMed] [Google Scholar]