Skip to main content Accessibility help

We use cookies to distinguish you from other users and to provide you with a better experience on our websites. Close this message to accept cookies or find out how to manage your cookie settings.

Close cookie message
×
Hostname: page-component-848d4c4894-pjpqr Total loading time: 0 Render date: 2024-07-03T03:13:24.540Z Has data issue: false hasContentIssue false

27 - Clinical trials

Published online by Cambridge University Press:  30 October 2009

By
Richard E. Ashcroft  and
A. M. Viens
Edited by
Peter A. Singer  and
A. M. Viens
Richard E. Ashcroft
Affiliation:
Professor University of London, UK
A. M. Viens
Affiliation:
Faculty of Philosophy University of Oxford, UK
Peter A. Singer
Affiliation:
University of Toronto
A. M. Viens
Affiliation:
University of Oxford
Get access

Summary

Dr. D, a clinical investigator, is conducting a clinical trial on a recently developed therapy for the treatment of a progressive neurodegenerative disorder. While initial results in a previous study generally appeared promising, the therapy has been associated with fatal bone marrow suppression in approximately 1% of patients. A colleague pediatrician, who has a patient with this neurodegenerative disorder, asks Dr. D if the child can be enrolled in the clinical trial. There are no data in the literature about this therapy having ever been used or tested in children with this condition, and Dr. D wonders whether the child should be included in the trial.

What are clinical trials?

Clinical trials are scientific evaluations of medical interventions for the treatment of somatic or psychological conditions that provide an analysis of the quality, safety, and efficacy of particular products, or a method of evaluating two products for their comparative value. While clinical trials are most often used to test therapeutic pharmaceutical products, they can also be utilized to evaluate medical devices or surgical procedures, plus other preventive, screening, detection, and non-pharmacological therapeutic products/methods.

Clinical trials influence clinical practice by providing vital information to clinicians and patients to use in assessing appropriate treatment options. Clinical trials allow for the generation of sound empirical evidence that individuals can use to address important questions concerning the benefits and harms of particular therapies in a scientifically rigorous and ethical way.

Type
Chapter
Information
The Cambridge Textbook of Bioethics , pp. 201 - 206
Publisher: Cambridge University Press
Print publication year: 2008

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

Ashcroft, R. (1999). Equipoise, knowledge and ethics in clinical research and practice. Bioethics 13: 314–26.CrossRefGoogle ScholarPubMed
Ashcroft, R. (2004). Gene therapy in the clinic: whose risks?. Trend Biotechnol 22: 560–3.CrossRefGoogle ScholarPubMed
Ashcroft, R. E., Chadwick, D. W., Clark, S. R. L., et al. (1997). Implications of socio-cultural contexts for ethics of clinical trials. Health Technol Assess 1: 1–66.Google ScholarPubMed
Bartlett, C., Doyal, L., Ebrahim, S., et al. (2005). The causes and effects of socio-demographic exclusions for clinical trials. Health Technol Assess 9: 1–152.CrossRefGoogle ScholarPubMed
Central Office for Research Ethics Committees (2006). Website (http://www.corec.org.uk/applicants/index.htm) accessed 14 July 2006.
Chow, S. C. and Liu, J. P. (2003). Design and Analysis of Clinical Trials: Concepts and Methodologies. New York: John Wiley.CrossRefGoogle Scholar
Cochrane, A. (1972). Effectiveness and Efficiency: Random Reflections on Health Services. London: Nuffield Provincial Hospitals Trust.Google Scholar
Council of the International Organizations of Medical Sciences (CIOMS) (2002). International Ethical Guidelines for Biomedical Research Involving Human Subjects. Geneva: CIOMS.Google Scholar
Daly, J. (2005). Evidence-Based Medicine and the Search for a Science of Clinical Care. Berkeley, CA: University of California Press.Google Scholar
Edwards, S. J. L., Lilford, R. J., Braunholtz, D. A., et al. (1998). Ethical issues in the design and conduct of randomised clinical trials. Health Technol Assess 2: 1–128.Google Scholar
European Union (2001). Clinical Trials Directive, 2001/20/EC. Brussels: European Communities Press.Google Scholar
Freedman, B. (1987). Equipoise and the ethics of clinical research. N Engl J Med 317: 141–5.CrossRefGoogle ScholarPubMed
Freireich, E. J. and Gehan, E. A. (1979). The limitations of randomized clinical trials. In Methods in Cancer Research: Cancer Drug Development, ed. DeVita, V. T. and Busch, H.. New York: Academic Press, pp. 277–310.Google Scholar
Fried, C. (1974). Medical Experimentation: Personal Integrity and Social Policy. New York: Elsevier.Google Scholar
General Medical Council (2002). Research: The Role and Responsibilities of Doctors. London: General Medical Council.Google Scholar
Horton, R. and Smith, R. (1999). Time to register randomised trials. The case is now unanswerable. BMJ 319: 865–6.CrossRefGoogle ScholarPubMed
International Committee of Medical Journal Editors (2006). Uniform Requirements for Manuscripts Submitted to Biomedical Journals: Writing and Editing for Biomedical Publication. Philadelphia, PA: American College of Physicians.Google Scholar
International Committee on Harmonization (1996). Tripartite Guideline E6(1): Good Clinical Practices. Geneva: International Committee on Harmonization (http://www.ich.org/LOB/media/MEDIA482.pdf) accessed 17 July 2006.
Levine, R. J. (1998). Ethics and Regulation of Clinical Research, 2nd edn. New Haven, CT: Yale University Press.Google Scholar
Medical Research Council (1998). MRC Guidelines for Good Clinical Practice in Clinical Trials. London: Medical Research Council.Google Scholar
Merritt, M. (2005). Moral conflict in clinical trials. Ethics 115: 306–30.CrossRefGoogle ScholarPubMed
Miller, P. B. and Weijer, C. (2003). Rehabilitating equipoise. Kennedy Inst Ethics J 13: 93–118.CrossRefGoogle ScholarPubMed
Piantadosi, S. (1997). Clinical Trials: A Methodologic Perspective. New York: John Wiley.Google Scholar
Plomer, A. (2005). The Law and Ethics of Medical Research: International Bioethics and Human Rights, Oxford: Cavendish.Google Scholar
Reeves, B., MacLehose, R., Harvey, I. M. et al. (2001). A review of observational, quasi-experimental and randomised study designs for the evaluation of the effectiveness of healthcare interventions. In The Advanced Handbook of Methods in Evidence Based Healthcare, ed. Stevens, A. J., Abrams, K., Brazier, J., Fitzpatrick, R., Lilford, R. J.. London: Sage, pp. 116–35.CrossRefGoogle Scholar
Rennie, D. (2004). Trial registration: a great idea switches from ignored to irresistible. JAMA 292: 1359–62.CrossRefGoogle ScholarPubMed
Robinson, E. J., Kerr, C. E. P., Stevens, A. J., et al. (2005). Lay public's understanding of equipoise and randomisation in randomised controlled trials. Health Technol Assess 9: 1–178.CrossRefGoogle ScholarPubMed
Schüklenk, U. and Ashcroft, R. E. (2000). International research ethics. Bioethics 14: 158–72.CrossRefGoogle ScholarPubMed
Simes, R. J. (1986). Publication bias: the case for an international registry of clinical trials. J Clin Oncol 4: 1529–41.CrossRefGoogle ScholarPubMed
US Department of Health and Human Services (2005). Code of Federal Regulations, Title 45. Washington DC: US Government Printing Office.
US Health Insurance Portability and Accountability Act of 1996, Public Law 104–191, 104th Congress (http://aspe. hhs.gov/admnsimp/p1104191.htm) accessed 7 October 2005.
Weijer, C. and Miller, P. B. (2004). When are research risks reasonable in relation to anticipated benefits?Nat Med 10: 570–3.CrossRefGoogle ScholarPubMed
World Medical Association (1964). Declaration of Helsinki. Ethical principles for medical research involving human subjects. JAMA 284: 3043–3046.Google Scholar

Save book to Kindle

To save this book to your Kindle, first ensure coreplatform@cambridge.org is added to your Approved Personal Document E-mail List under your Personal Document Settings on the Manage Your Content and Devices page of your Amazon account. Then enter the ‘name’ part of your Kindle email address below. Find out more about saving to your Kindle.

Note you can select to save to either the @free.kindle.com or @kindle.com variations. ‘@free.kindle.com’ emails are free but can only be saved to your device when it is connected to wi-fi. ‘@kindle.com’ emails can be delivered even when you are not connected to wi-fi, but note that service fees apply.

Find out more about the Kindle Personal Document Service.

Available formats
×

Save book to Dropbox

To save content items to your account, please confirm that you agree to abide by our usage policies. If this is the first time you use this feature, you will be asked to authorise Cambridge Core to connect with your account. Find out more about saving content to Dropbox.

Available formats
×

Save book to Google Drive

To save content items to your account, please confirm that you agree to abide by our usage policies. If this is the first time you use this feature, you will be asked to authorise Cambridge Core to connect with your account. Find out more about saving content to Google Drive.

Available formats
×