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Clinical Trials: Design, Conduct and Analysis
Abstract
This book starts with a general discussion of clinical trials. It goes on to describe the activities of a typical study, comparing single center and multicenter trials, reviewing cost factors and assessing the usefulness of clinical trials for the practice of medicine. The book then considers design principles and practices such as sample size estimates and the mechanics of treatment masking, and provides a detailed consideration of a variety of issues involved in implementation and analysis, including execution, follow-up, and quality assurance. The book also includes a three-chapter section on management and an in-depth treatment of reporting procedures.
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Moher, D., Hopewell, S., Schulz, K. F., Montori, V., Gotzsche, P. C., Devereaux, P. J., Elbourne, D., Egger, M., & Altman, D. G. (2010) · BMJ · doi:10.1136/bmj.c869 · Cited by 8,883
Evaluating the public health impact of health promotion interventions: the RE-AIM framework.
Glasgow, R. E., Vogt, T. M., & Boles, S. M. (1999) · American Journal of Public Health · doi:10.2105/ajph.89.9.1322 · Cited by 7,217
Equivalence of the Mediation, Confounding and Suppression Effect
MacKinnon, D. P., Krull, J. L., & Lockwood, C. M. (2000) · Prevention Science · doi:10.1023/a:1026595011371 · Cited by 4,188
The Revised CONSORT Statement for Reporting Randomized Trials: Explanation and Elaboration
Altman, D. G., Schulz, K. F., Moher, D., Egger, M., Davidoff, F., Elbourne, D., Gøtzsche, P. C., Lang, T., & for the CONSORT Group (2001) · Annals of Internal Medicine · doi:10.7326/0003-4819-134-8-200104170-00012 · Cited by 3,835
Evaluating non-randomised intervention studies
Deeks, J., Dinnes, J., D'Amico, R., Sowden, A., Sakarovitch, C., Song, F., Petticrew, M., & Altman, D. (2003) · Health Technology Assessment · doi:10.3310/hta7270 · Cited by 2,907
Mediators and Moderators of Treatment Effects in Randomized Clinical Trials
Kraemer, H. C., Wilson, G. T., Fairburn, C. G., & Agras, W. S. (2002) · Archives of General Psychiatry · doi:10.1001/archpsyc.59.10.877 · Cited by 2,562
The COMET Handbook: version 1.0
Williamson, P. R., Altman, D. G., Bagley, H., Barnes, K. L., Blazeby, J. M., Brookes, S. T., Clarke, M., Gargon, E., Gorst, S., Harman, N., et al. (2017) · Trials · doi:10.1186/s13063-017-1978-4 · Cited by 2,011
Inadequate Antimicrobial Treatment of Infections
Kollef, M. H., Sherman, G., Ward, S., & Fraser, V. J. (1999) · Chest · doi:10.1378/chest.115.2.462 · Cited by 1,805
Ibrahim, E. H., Sherman, G., Ward, S., Fraser, V. J., & Kollef, M. H. (2000) · Chest · doi:10.1378/chest.118.1.146 · Cited by 1,779
Standards of Evidence: Criteria for Efficacy, Effectiveness and Dissemination
Flay, B. R., Biglan, A., Boruch, R. F., Castro, F. G., Gottfredson, D., Kellam, S., Mościcki, E. K., Schinke, S., Valentine, J. C., & Ji, P. (2005) · Prevention Science · doi:10.1007/s11121-005-5553-y · Cited by 1,338
Moher, D., Jadad, A. R., Nichol, G., Penman, M., Tugwell, P., & Walsh, S. (1995) · Controlled Clinical Trials · doi:10.1016/0197-2456(94)00031-w · Cited by 1,308
Surgical versus nonsurgical therapy for lumbar spinal stenosis
Weinstein, J. N., Tosteson, T. D., Lurie, J. D., Tosteson, A. N. A., Blood, E., Hanscom, B., Herkowitz, H., Cammisa, F., Albert, T., Boden, S. D., et al. (2008) · New England Journal of Medicine · doi:10.1056/nejmoa0707136 · Cited by 1,229
Blinding in randomised trials: hiding who got what
Schulz, K. F., & Grimes, D. A. (2002) · The Lancet · doi:10.1016/s0140-6736(02)07816-9 · Cited by 952
Allocation concealment in randomised trials: defending against deciphering
Schulz, K. F., & Grimes, D. A. (2002) · The Lancet · doi:10.1016/s0140-6736(02)07750-4 · Cited by 923
Generation of allocation sequences in randomised trials: chance, not choice
Schulz, K. F., & Grimes, D. A. (2002) · The Lancet · doi:10.1016/s0140-6736(02)07683-3 · Cited by 774
Oral topiramate for treatment of alcohol dependence: A randomised controlled trial
Johnson, B. A., Ait-Daoud, N., Bowden, C. L., DiClemente, C. C., Roache, J. D., Lawson, K., Javors, M. A., & Ma, J. Z. (2003) · The Lancet · doi:10.1016/s0140-6736(03)13370-3 · Cited by 743
Guidelines for Controlled Trials of Drugs in Migraine: Second Edition
International Headache Society Clinical Trials Subcommittee, Tfelt-Hansen, P., Block, G., Dahlöf, C., Diener, H.-C., Ferrari, M., Goadsby, P., Guidetti, V, Jones, B., Lipton, R., et al. (2000) · Cephalalgia · doi:10.1046/j.1468-2982.2000.00117.x · Cited by 698
Self-citationSample size calculations in randomised trials: mandatory and mystical
Schulz, K. F., & Grimes, D. A. (2005) · The Lancet · doi:10.1016/s0140-6736(05)61034-3 · Cited by 549
Testing for baseline balance in clinical trials
Senn, S. (1994) · Statistics in Medicine · doi:10.1002/sim.4780131703 · Cited by 503
Frasure-Smith, N., Lespérance, F., Prince, R. H., Verrier, P., Garber, R. A., Juneau, M., Wolfson, C., & Bourassa, M. G. (1997) · The Lancet · doi:10.1016/s0140-6736(97)02142-9 · Cited by 461
Assessing the Quality of Randomized Controlled Trials:Current Issues and Future Directions
Moher, D., Jadad, A. R., & Tugwell, P. (1996) · International Journal of Technology Assessment in Health Care · doi:10.1017/s0266462300009570 · Cited by 436
A Randomized Controlled Trial of Stress Reduction for Hypertension in Older African Americans
Schneider, R. H., Staggers, F., Alexander, C. N., Sheppard, W., Rainforth, M., Kondwani, K., Smith, S., & King, C. G. (1995) · Hypertension · doi:10.1161/01.hyp.26.5.820 · Cited by 373
Multiplicity in randomised trials I: endpoints and treatments
Schulz, K. F., & Grimes, D. A. (2005) · The Lancet · doi:10.1016/s0140-6736(05)66461-6 · Cited by 366
The Diabetes Network Internet-Based Physical Activity Intervention
McKay, H. G., King, D., Eakin, E. G., Seeley, J. R., & Glasgow, R. E. (2001) · Diabetes Care · doi:10.2337/diacare.24.8.1328 · Cited by 363
Manuscript Quality before and after Peer Review and Editing at Annals of Internal Medicine
Goodman, S. N., Berlin, J., Fletcher, S. W., & Fletcher, R. H. (1994) · Annals of Internal Medicine · doi:10.7326/0003-4819-121-1-199407010-00003 · Cited by 324
Moderators of Treatment Outcomes: Clinical, Research, and Policy Importance
Kraemer, H. C., Frank, E., & Kupfer, D. J. (2006) · JAMA · doi:10.1001/jama.296.10.1286 · Cited by 310
Effect of Mindfulness‐Based stress reduction in rheumatoid arthritis patients
Pradhan, E. K., Baumgarten, M., Langenberg, P., Handwerger, B., Gilpin, A. K., Magyari, T., Hochberg, M. C., & Berman, B. M. (2007) · Arthritis Care & Research · doi:10.1002/art.23010 · Cited by 309
Glasgow, R. E., Magid, D. J., Beck, A., Ritzwoller, D., & Estabrooks, P. A. (2005) · Medical Care · doi:10.1097/01.mlr.0000163645.41407.09 · Cited by 308
Developing Robust, Sustainable, Implementation Systems Using Rigorous, Rapid and Relevant Science
Glasgow, R. E., & Chambers, D. (2012) · Clinical and Translational Science · doi:10.1111/j.1752-8062.2011.00383.x · Cited by 278
Children in low-income, urban settings: Interventions to promote mental health and well-being.
Black, M. M., & Krishnakumar, A. (1998) · American Psychologist · doi:10.1037/0003-066x.53.6.635 · Cited by 214
Pildal, J., Chan, A.-W., Hróbjartsson, A., Forfang, E., Altman, D. G., & Gøtzsche, P. C. (2005) · BMJ · doi:10.1136/bmj.38414.422650.8f · Cited by 209
How Appropriate are Popular Sample Size Formulas?
Kupper, L. L., & Hafner, K. B. (1989) · The American Statistician · doi:10.1080/00031305.1989.10475628 · Cited by 196
LeMaster, J. W., Mueller, M. J., Reiber, G. E., Mehr, D. R., Madsen, R. W., & Conn, V. S. (2008) · Physical Therapy · doi:10.2522/ptj.20080019 · Cited by 179
Garfein, R. S., Golub, E. T., Greenberg, A. E., Hagan, H., Hanson, D. L., Hudson, S. M., Kapadia, F., Latka, M. H., Ouellet, L. J., Purcell, D. W., et al. (2007) · AIDS · doi:10.1097/qad.0b013e32823f9066 · Cited by 159
Davis, M. C., & Zautra, A. J. (2013) · Annals of Behavioral Medicine · doi:10.1007/s12160-013-9513-7 · Cited by 151
Recruitment, Retention, and Blinding in Clinical Trials
Page, S. J., & Persch, A. C. (2013) · American Journal of Occupational Therapy · doi:10.5014/ajot.2013.006197 · Cited by 148
Brown, C. H., & Liao, J. (1999) · American Journal of Community Psychology · doi:10.1023/a:1022142021441 · Cited by 142
Blinding during data analysis and writing of manuscripts
Gøtzsche, P. C. (1996) · Controlled Clinical Trials · doi:10.1016/0197-2456(95)00263-4 · Cited by 123
Ornstein, S., Jenkins, R. G., Nietert, P. J., Feifer, C., Roylance, L. F., Nemeth, L., Corley, S., Dickerson, L., Bradford, W. D., & Litvin, C. (2004) · Annals of Internal Medicine · doi:10.7326/0003-4819-141-7-200410050-00008 · Cited by 125
Fundamentals of clinical trial design
Evans, S. R. (2010) · Journal of Experimental Stroke and Translational Medicine · doi:10.6030/1939-067x-3.1.19 · Cited by 119
Seshadri, S., Beiser, A., Au, R., Wolf, P. A., Evans, D. A., Wilson, R. S., Petersen, R. C., Knopman, D. S., Rocca, W. A., Kawas, C. H., et al. (2011) · Alzheimer's & Dementia · doi:10.1016/j.jalz.2010.12.002 · Cited by 97
Sydes, M. R., Spiegelhalter, D. J., Altman, D. G., Babiker, A. B., Parmar, M. K., & DAMOCLES Group (2004) · Clinical Trials · doi:10.1191/1740774504cn004rr · Cited by 76
A scenario guideline for designing new teletreatments: a multidisciplinary approach
Huis in 't Veld, R. M., Widya, I. A., Bults, R. G., Sandsjö, L., Hermens, H. J., & Vollenbroek-Hutten, M. M. (2010) · Journal of Telemedicine and Telecare · doi:10.1258/jtt.2010.006003 · Cited by 62
Safety study of tirilazad mesylate in patients with acute ischemic stroke (STIPAS).
(1994) · Stroke · doi:10.1161/01.str.25.2.418 · Cited by 61
Toward prospective registration of clinical trials
Meinert, C. L. (1988) · Controlled Clinical Trials · doi:10.1016/0197-2456(88)90002-5 · Cited by 57
Self-citationThe HERITAGE Family Study: Quality assurance and quality control.
Gagnon, J. (1996) · Annals of Epidemiology · doi:10.1016/s1047-2797(96)00068-3 · Cited by 52
Sydes, M. R., Altman, D. G., Babikera, A. B., Parmar, M. K., Spiegelhalter, D. J., & DAMOCLES group (2004) · Clinical Trials · doi:10.1191/1740774504cn003oa · Cited by 49
Young, D. R., Coleman, K. J., Ngor, E., Reynolds, K., Sidell, M., & Sallis, R. E. (2014) · Preventing Chronic Disease · doi:10.5888/pcd11.140196 · Cited by 46
Alternative strategies in cardiac preclinical research and new clinical trial formats
Kreutzer, F. P., Meinecke, A., Schmidt, K., Fiedler, J., & Thum, T. (2022) · Cardiovascular Research · doi:10.1093/cvr/cvab075 · Cited by 36
Kleiderman, E., Boily, A., Hasilo, C., & Knoppers, B. M. (2018) · Stem Cell Research & Therapy · doi:10.1186/s13287-018-1055-2 · Cited by 34
Multisite Randomized Trials in Criminology
MacKenzie, D. L., Umamaheswar, J., & Lin, L.-C. (2013) · Experimental Criminology · doi:10.1017/cbo9781139424776.012 · Cited by 24
The Adequacy of Reporting Randomized, Controlled Trials in the Evaluation of Antidepressants
Streiner, D. L., & Joffe, R. (1998) · The Canadian Journal of Psychiatry · doi:10.1177/070674379804301008 · Cited by 15
Metadata
- Authors
- Meinert, C. L.
- Venue
- DigitalGeorgetown (Georgetown University Library)
- Publisher
- Oxford University PressNew York
- Published
- 1986-09-11
- OpenAlex
- W2080813431
- Cited by
- 756
- References
- 0
- FWCI
- 12.18
- Type
- journal article
- Language
- en
- Open access
- closed
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