Abstract
To relieve human suffering—the motto of our profession—extends beyond our current patients to those in the future. The progress of medicine depends on medical research. Our discussion will be limited to clinical trials with critical ethical issues due to the active involvement of patients. From the patients’ standpoint, the essential demands are: a scientifically sound research plan; free choice to enter a trial or receive routine treatment; understandable informed consent; and, in the case of randomized trials, physician’s equipoise (sincere uncertainty) regarding preferences to the proposed treatments. Despite all efforts, some ethical costs are inevitable: in comparison to routine treatment, clinical research often includes additional diagnostics, the collection of personal data, and limited freedom to individualize treatment. Publication of results serves to counterbalance these inevitable ethical costs by offering useful information to benefit future generations of patients. While the commercial interests of sponsors are understandable and inevitable, investigators and physicians should avoid any bias in planning a clinical trial, in its conduct, and in final analysis and publication.
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
Notes
- 1.
Development of a second cancer five or more years after successful treatment of the first cancer is a significant problem in oncology and is especially worrying in pediatric oncology.
- 2.
The data about the used drugs are not disclosed in order to prevent identification of the study and its sponsor.
References
Berger O, Grønberg BH, Sand K, Kaasa S, Loge JH. The length of consent documents in oncological trials is doubled in twenty years. Ann Oncol. 2009;20:379–85.
Droste S, Herrmann-Frank A, Scheibler F, Krones T. Ethical issues in autologous stem cell transplantation (ASCT) in advanced breast cancer: a systematic literature review. BMC Med Ethics. 2011;12:6.
Jeremic B, Milicic B, Milisavljevic S. Clinical prognostic factors in patients with locally advanced (stage III) nonsmall cell lung cancer treated with hyperfractionated radiation therapy with and without concurrent chemotherapy: single-institution experience in 600 patients. Cancer. 2011;117:2995–3003.
Mukherjee S. The emperor of all maladies: a biography of cancer. New York: Scribner; 2010. ISBN: 978-1-4391-0795-9.
Vogelzang NJ, Rusthoven JJ, Symanowski J, Denham C, Kaukel E, Ruffie P, et al. Phase III study of pemetrexed in combination with cisplatin versus cisplatin alone in patients with malignant pleural mesothelioma. J Clin Oncol. 2003;21:2629–30.
Kovac V, Zwitter M, Rajer M, Marin A, Debeljak A, Smrdel U, et al. A phase II trial of low-dose gemcitabine in prolonged infusion and cisplatin for malignant pleural mesothelioma. Anti-Cancer Drugs. 2012;23:230–8.
https://www.wma.net/wp-content/uploads/2016/11/DoH-Oct2013-JAMA.pdf
Zwitter M. Toxicity and quality of life in published clinical trials for advanced lung cancer. Support Care Cancer. 2018;26:3453–9. https://doi.org/10.1007/s00520-018-4214-1.
Ciuleanu T, Brodowicz T, Zielinski C, Kim JH, Krzakowski M, Laack E, et al. Maintenance pemetrexed plus best supportive care versus placebo plus best supportive care for non-small-cell lung cancer: a randomised, double-blind, phase 3 study. Lancet. 2009;374:1432–40.
Suggested Reading
Amsterdam JD, McHenry LB, Jureidini JN. Industry-corrupted psychiatric trials. Psychiatr Pol. 2017;51:993–1008. https://doi.org/10.12740/PP/80136.
Bell JA, Balneaves LG. Cancer patient decision making related to clinical trial participation: an integrative review with implications for patients’ relational autonomy. Support Care Cancer. 2015;23:1169–96. https://doi.org/10.1007/s00520-014-2581-9.
Denson AC, Mahipal A. Participation of the elderly population in clinical trials: barriers and solutions. Cancer Control. 2014;21:209–14.
Every-Palmer S, Howick J. How evidence-based medicine is failing due to biased trials and selective publication. J Eval Clin Pract. 2014;20:908–14. https://doi.org/10.1111/jep.12147.
Flacco ME, Manzoli L, Boccia S, Capasso L, Aleksovska K, Rosso A, et al. Head-to-head randomized trials are mostly industry sponsored and almost always favor the industry sponsor. J Clin Epidemiol. 2015;68:811–20. https://doi.org/10.1016/j.jclinepi.2014.12.016.
Flory JH, Mushlin AI, Goodman ZI. Proposals to conduct randomized controlled trials without informed consent: a narrative review. J Gen Intern Med. 2016;31:1511–8. PMID: 27384536.
Galton DJ, Dodge JA. Legal distinctions between clinical research and clinical investigation: lessons from a professional misconduct trial. Int J Philos Stud. 2013;1:13–6.
Gillies K, Entwistle V, Treweek SP, Fraser C, Williamson PR, Campbell MK. Evaluation of interventions for informed consent for randomised controlled trials (ELICIT): protocol for a systematic review of the literature and identification of a core outcome set using a Delphi survey. Trials. 2015;16:484. https://doi.org/10.1186/s13063-015-1011-8.
Glackin SN. Placebo treatments, informed consent and ‘the grip of a false picture’. J Med Ethics. 2015;41:669–72. https://doi.org/10.1136/medethics-2014-102332.
Halkoaho A, Pietilä AM, Ebbesen M, Karki S, Kangasniemi M. Cultural aspects related to informed consent in health research: a systematic review. Nurs Ethics. 2016;23:698–712. https://doi.org/10.1177/0969733015579312.
Herson J. Strategies for dealing with fraud in clinical trials. Int J Clin Oncol. 2016;21:22–7. https://doi.org/10.1007/s10147-015-0876-6.
Kuthning M, Hundt F. Aspects of vulnerable patients and informed consent in clinical trials. Ger Med Sci. 2013;11:Doc03. https://doi.org/10.3205/000171.
Lamont S, Jeon YH, Chiarella M. Assessing patient capacity to consent to treatment: an integrative review of instruments and tools. J Clin Nurs. 2013;22:2387–403. https://doi.org/10.1111/jocn.12215.
Linker A, Yang A, Roper N, Whitaker E, Korenstein D. Impact of industry collaboration on randomised controlled trials in oncology. Eur J Cancer. 2017;72:71–7. https://doi.org/10.1016/j.ejca.2016.11.005.
Leibson T, Koren G. Informed consent in pediatric research. Paediatr Drugs. 2015;17:5–11. https://doi.org/10.1007/s40272-014-0108-y.
Liao SM, O’Neil C, editors. Current controversies in bioethics. Abingdon: Routledge; 2017. ISBN-13: 978-1138855823.
Myles PS, Williamson E, Oakley J, Forbes A. Ethical and scientific considerations for patient enrollment into concurrent clinical trials. Trials. 2014;15:470. https://doi.org/10.1186/1745-6215-15-470.
Nishimura A, Carey J, Erwin PJ, Tilburt JC, Murad MH, McCormick JB. Improving understanding in the research informed consent process: a systematic review of 54 interventions tested in randomized control trials. BMC Med Ethics. 2013;14:28. https://doi.org/10.1186/1472-6939-14-28.
Probst P, Knebel P, Grummich K, Tenckhoff S, Ulrich A, Büchler MW, Diener MK. Industry bias in randomized controlled trials in general and abdominal surgery: an empirical study. Ann Surg. 2016;264:87–92. https://doi.org/10.1097/SLA.0000000000001372.
Sture J. The ethics and biosecurity toolkit for scientists. Singapore: World Scientific; 2016. ISBN-13: 978-1786340924.
Williams CJ, Zwitter M. Informed consent in European multicentre randomised clinical trials—are patients really informed? Eur J Cancer. 1994;30A:907–10.
Willmott C, Macip S. Where science and ethics meet: dilemmas at the Frontiers of medicine and biology. Westport, CT: Praeger; 2016. ISBN-13: 978-1440851346.
Zaner RM. A critical examination of ethics in health care and biomedical research: voices and visions. Berlin: Springer; 2016. ISBN-13: 978-3319382517
Zhang D, Freemantle N, Cheng KK. Are randomized trials conducted in China or India biased? A comparative empirical analysis. J Clin Epidemiol. 2011;64:90–5. https://doi.org/10.1016/j.jclinepi.2010.02.010.
Zwitter M. A personal critique: evidence-based medicine, methodology, and ethics of randomised clinical trials. Crit Rev Oncol Hematol. 2001;40:125–30.
Zwitter M, Tobias JS. A survey of the ethical considerations in randomised trials for lung cancer. Lung Cancer. 1998;19:197–210.
Author information
Authors and Affiliations
Rights and permissions
Copyright information
© 2019 Springer Nature Switzerland AG
About this chapter
Cite this chapter
Zwitter, M. (2019). Research. In: Medical Ethics in Clinical Practice. Springer, Cham. https://doi.org/10.1007/978-3-030-00719-5_19
Download citation
DOI: https://doi.org/10.1007/978-3-030-00719-5_19
Published:
Publisher Name: Springer, Cham
Print ISBN: 978-3-030-00718-8
Online ISBN: 978-3-030-00719-5
eBook Packages: MedicineMedicine (R0)