Prerandomization of clinical trials: A more ethical way for performing cleft palate research

Plastic and Reconstructive Surgery

Volumn 102, Issue 5, 1998, Pages 1724-1728

  Berkowitz, Samuel ^a  

^a Miami Craniofacial Anomalies Found   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CLEFT PALATE; CLINICAL RESEARCH; DOCTOR PATIENT RELATION; EDITORIAL; HUMAN; INFORMED CONSENT; INTERMETHOD COMPARISON; MEDICAL ETHICS; METHODOLOGY; PATIENT CARE; PATIENT RIGHT; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL;

BIOMEDICAL AND BEHAVIORAL RESEARCH; CLINICAL APPROACH/SOURCE; CONTROL GROUPS; DEONTOLOGICAL ETHICS; INFANTS; PARENTAL CONSENT; RISKS AND BENEFITS; UTILITARIANISM;

CLEFT PALATE; CONTROL GROUPS; DISCLOSURE; ETHICAL THEORY; ETHICS, MEDICAL; HUMANS; INFORMED CONSENT; PARENTAL CONSENT; RANDOMIZED CONTROLLED TRIALS; RESEARCH DESIGN; RISK ASSESSMENT;

EID: 0031752245     PISSN: 00321052     EISSN: None     Source Type: Journal    
DOI: 10.1097/00006534-199810000-00065     Document Type: Editorial

References (22)

1. Berkowitz, S. Ethical issues in the surgical repair of cleft palate. Cleft Palate Craniofac. J. 32: 271, 1995.
2. Nickolson, R., and Hale, R. The structure of the argument. In E. Erwin, S. Gendin, and L. Kleiman (Eds.), Ethical Issues in Scientific Research: An Anthology. New York: Garland Publishing, 1994.
3. Giffin, J. P. Modern utilitarianism. Rev. Int. Philos. 1983.
4. Dworkin, R. M. Taking Rights Seriously. Boston: Harvard University Press, 1977.
5. Gifford, F. The conflict between randomized clinical trials and the therapeutic obligation. J. Med. Philos. 347: 366, 1986.
6. Marquis, D. Leaving Therapy to Chance: An Impasse in the Ethics of Randomized Clinical Trials. Hastings Center Bibliography of Ethics, Biomedicine and Professional Responsibility. Westport, Conn.: Greenwood Publishing Group, 1984.
7. Blackdahl, M., and Nordin, K. E. Replacement of the maxillary bone defect in cleft palate. Acta. Chir. Scand. 122: 131, 1961.
8. Krens, O. Primary osteoplasty in patients with cleft of the lip, alveolus and palate. Acta. Otorhinolaryngol. Belg. 22: 687, 1968.
9. Rosenstein, S. W., Jacobson, B. N., Monroe, C., Griffin, B. H., and McKinney, P. A series of cleft lip and palate children five years after undergoing orthopedic and bone grafting procedures. Angle Orthod. 42: 1, 1972.
10. Friede, H., and Johanson, B. A follow-up of cleft children treated with primary bone grafting. 1. Orthodontic aspects. Scand. J. Plast. Reconstr. Surg. 8: 88, 1974.
11. Tagnon, H.J. Ethical Consideration in Controlled Clinical Trials. In M. E. Buyse, M. J. Staguet, and R. J. Sylvester (Eds.), Cancer Clinical Trials. Methods and Practice. Oxford: Oxford University Press, 1984.
12. Berkowitz, S. Timing Cleft Palate Closure: Age Should Not Be the Sole Determinant. In M. M. Cohen, Jr., and B. R. Rollnick (Eds.), Craniofacial Dysmorphology: Studies in Honor of Samuel Pruzansky (Suppl. 1). New York: Alan R. Liss, 1985. Pp. 69-83.
13. Berkowitz, S. Cleft Lip and Palate: Perspectives in Management with an Introduction to Other Craniofacial Anomalies. San Diego: Singular Publishing Group, 1996.
14. Zelen, M. Statistical options in clinical trials. Semin. Oncol. 4: 446, 1977.
15. Buyse, M. E., Staquet, M. J., and Sylvester, R. J. (Eds.) Cancer Clinical Trials: Methods and Practice. Oxford: Oxford University Press, 1984. Pp. 20-21.
16. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. Belmont Report. Washington, DC: U.S. Government Printing Office, 1979.
17. Gifford, F. The conflict between randomized clinical trials and the therapeutic obligation. In E. Erwin, S. Gendin, and L. Kleiman (Eds.), Ethical Issues in Scientific Research: An Anthology. New York: Garland Publishing, 1994.
18. Medical research council report: Responsibility in investigations on human subjects. Cmnd. 2382. London: Medical Research Council, 1962.
19. Code of Federal Regulations. 45 CFR and certain related laws and regulations on protection of human subjects. Revised 11 January 1978. PPR Reports, DHEW, 1978.
20. Zelen, M. A new design for randomized trials. N. Engl. J. Med. 300: 1242, 1979.
21. Zelen, M. Alternative to classic randomized trials. Surg. Clin. North Am. 61: 1425, 1981.
22. Zelen, M. Strategy and alternate randomized designs in cancer clinical trials. Cancer Treat. Rep. 66: 1095, 1982.