Abstract
Participating in clinical studies constitutes an important aspect in oncology, even in incurable diseases, and is indispensable for improving anticancer therapy with respect to efficacy and side effects. Nevertheless, numerous medical and ethical problems can be identified in clinical situations where transition to palliative care may interfere with the enrollment in early phase clinical trials and the hopeful expectations they generate. In this chapter we introduce different moral points of view from which one can analyze the normative problems and issues related to the decision whether a patient with advanced cancer should enter an early phase clinical trial. We then address key ethical issues using paradigmatic cases that raise ethical questions: (1) prerequisites for the informed consent, (2) conflict of obligations, and (3) conflicts of interest in the context of early phase trial participations of advanced-cancer patients. We then discuss possible strategies and limitations for reconciling a clinical research-oriented and palliative care perspective with regard to patients with advanced cancer. We conclude with specific principles of how these key ethical issues can best be addressed.
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Notes
- 1.
While we do not view the question of “palliative care versus phase 1 trial” as one to which there are only mutually exclusive answers, we pursue this dichotomy for most parts of the article because in our experience this reflects the perception of many patients and clinicians who are faced with the situation in current clinical practice.
- 2.
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References
Agrawal M, Grady C, Fairclough DL, Meropol NJ, Maynard K, Emanuel EJ (2006) Patients’ decision-making process regarding participation in phase I oncology research. J Clin Oncol 24(27):4479–4484. doi:10.1200/jco.2006.06.0269
Appelbaum PS, Roth LH, Lidz CW, Benson P, Winslade W (1987) False hopes and best data: consent to research and the therapeutic misconception. Hastings Cent Rep 17(2):20–24
Beauchamp TL, Childress JF (2013) Principles of biomedical ethics, 7th edn. Oxford University Press, New York [u.a.]
Bruera E, Hui D (2012) Conceptual models for integrating palliative care at cancer centers. J Palliat Med 15(11):1261–1269. doi:10.1089/jpm.2012.0147
Clayton JM, Butow PN, Tattersall MH (2005) When and how to initiate discussion about prognosis and end-of-life issues with terminally ill patients. J Pain Symptom Manage 30(2):132–144. doi:10.1016/j.jpainsymman.2005.02.014
Dalal S, Palla S, Hui D, Nguyen L, Chacko R, Li Z, Fadul N, Scott C, Thornton V, Coldman B, Amin Y, Bruera E (2011) Association between a name change from palliative to supportive care and the timing of patient referrals at a comprehensive cancer center. Oncologist 16(1):105–111. doi:10.1634/theoncologist. 2010-0161
Emanuel EJ, Wendler D, Grady C (2000) What makes clinical research ethical? JAMA 283(20):2701–2711
Fadul N, Elsayem A, Palmer JL, Del Fabbro E, Swint K, Li Z, Poulter V, Bruera E (2009) Supportive versus palliative care: what’s in a name?: a survey of medical oncologists and midlevel providers at a comprehensive cancer center. Cancer 115(9):2013–2021. doi:10.1002/cncr.24206
Fallowfield LJ, Jenkins VA, Beveridge HA (2002) Truth may hurt but deceit hurts more: communication in palliative care. Palliat Med 16(4):297–303
Fallowfield LJ, Solis-Trapala I, Jenkins VA (2012) Evaluation of an educational program to improve communication with patients about early-phase trial participation. Oncologist 17(3):377–383. doi:10.1634/theoncologist. 2011-0271
Ferris FD, Bruera E, Cherny N, Cummings C, Currow D, Dudgeon D, Janjan N, Strasser F, von Gunten CF, Von Roenn JH (2009) Palliative cancer care a decade later: accomplishments, the need, next steps – from the American Society of Clinical Oncology. J Clin Oncol 27(18):3052–3058. doi:10.1200/jco.2008.20.1558
Finlay E, Lu HL, Henderson HR, O’Dwyer PJ, Casarett DJ (2009) Do phase 1 patients have greater needs for palliative care compared with other cancer patients? Cancer 115(2):446–453. doi:10.1002/cncr.24025
Hancock K, Clayton JM, Parker SM, der Wal S, Butow PN, Carrick S, Currow D, Ghersi D, Glare P, Hagerty R, Tattersall MH (2007) Truth-telling in discussing prognosis in advanced life-limiting illnesses: a systematic review. Palliat Med 21(6):507–517. doi:10.1177/0269216307080823
Ho J, Pond GR, Newman C, Maclean M, Chen EX, Oza AM, Siu LL (2006) Barriers in phase I cancer clinical trials referrals and enrollment: five-year experience at the Princess Margaret Hospital. BMC Cancer 6:263. doi:10.1186/1471-2407-6-263
Horstmann E, McCabe MS, Grochow L, Yamamoto S, Rubinstein L, Budd T, Shoemaker D, Emanuel EJ, Grady C (2005) Risks and benefits of phase 1 oncology trials, 1991 through 2002. N Engl J Med 352(9):895–904. doi:10.1056/NEJMsa042220
Jefford M, Moore R (2008) Improvement of informed consent and the quality of consent documents. Lancet Oncol 9(5):485–493. doi:10.1016/s1470-2045(08)70128-1
Jenkins V, Solis-Trapala I, Langridge C, Catt S, Talbot DC, Fallowfield LJ (2011) What oncologists believe they said and what patients believe they heard: an analysis of phase I trial discussions. J Clin Oncol 29(1):61–68. doi:10.1200/jco.2010.30.0814
Joffe S, Cook EF, Cleary PD, Clark JW, Weeks JC (2001) Quality of informed consent in cancer clinical trials: a cross-sectional survey. Lancet 358(9295):1772–1777. doi:10.1016/s0140-6736(01)06805-2
Meyers FJ, Linder J, Beckett L, Christensen S, Blais J, Gandara DR (2004) Simultaneous care: a model approach to the perceived conflict between investigational therapy and palliative care. J Pain Symptom Manage 28(6):548–556. doi:10.1016/j.jpainsymman.2004.03.002
Morreim EM (1995) Conflict of interest. In: Reich WT (ed) Encyclopedia of bioethics. Free Press, New York, pp 459–465 [u.a.]
Pellegrino ED (2006) Toward a reconstruction of medical morality. Am J Bioeth 6(2):65–71. doi:10.1080/15265160500508601
Penel N, Delord JP, Bonneterre ME, Bachelot T, Ray-Coquard I, Blay JY, Pascal LB, Borel C, Filleron T, Adenis A, Bonneterre J (2010) Development and validation of a model that predicts early death among cancer patients participating in phase I clinical trials investigating cytotoxics. Invest New Drugs 28(1):76–82. doi:10.1007/s10637-009-9224-x
National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, The Belmont Report (DHEW pub. no. (OS) 78-0012). Washington, DC: United States Government Printing Office.
Schildmann J, Sandow V, Vollmann J (2011) Interessenkonflikte – ethische Aspekte. In: Lieb K (ed) Interessenkonflikte in der Medizin: Hintergründe und Lösungsmöglichkeiten. Springer, Berlin/Heidelberg, pp 47–59
Temel JS, Greer JA, Muzikansky A, Gallagher ER, Admane S, Jackson VA, Dahlin CM, Blinderman CD, Jacobsen J, Pirl WF, Billings JA, Lynch TJ (2010) Early palliative care for patients with metastatic non-small-cell lung cancer. N Engl J Med 363(8):733–742. doi:10.1056/NEJMoa1000678
Thompson DF (1993) Understanding financial conflicts of interest. N Engl J Med 329:573–576
Winkler EC, Reiter-Theil S, Lange-Riess D, Schmahl-Menges N, Hiddemann W (2009) Patient involvement in decisions to limit treatment: the crucial role of agreement between physician and patient. J Clin Oncol 27(13):2225–2230. doi:10.1200/jco.2008.17.9515
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Winkler, E.C., Schildmann, J. (2015). Palliative Care for Patients Participating in Experimental or Clinical Oncology Studies. In: Alt-Epping, B., Nauck, F. (eds) Palliative Care in Oncology. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-662-46202-7_17
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