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COMMENTARY

Moral Justification of Phase 1 Oncology Trials

Pages 138-151 | Received 24 Jun 2013, Accepted 14 Mar 2014, Published online: 12 May 2014

REFERENCES

  • Flynn KE, Weinfurt KP, Seils DM, Decisional conflict among patients who accept or decline participation in phase I oncology studies. J Empir Res Hum Res Ethics. 2008;3:69–77.
  • Jansen LA, Appelbaum PS, Klein WM, Unrealistic optimism in early-phase oncology trials. IRB. 2011;33:1–8.
  • Tomamichel M, Jaime H, Degrate A, Proposing phase I studies: patients’, relatives’, nurses’ and specialists’ perceptions. Ann Oncol. 2000 Mar; 11:289–294; Nurgat ZA, Craig W, Campbell NC, et al. Patient motivations surrounding participation in phase I and phase II clinical trials of cancer chemotherapy. Br J Cancer. 2005;92:1001–1005.
  • Truong TH, Weeks JC, Cook EF, Joffe S. Altruism among participants in cancer clinical trials. Clin Trials. 2011;8:616–623.
  • Cheng JD, Hitt J, Koczwara B, Impact of quality of life on patient expectations regarding phase I clinical trials. J Clin Oncol. 2000;18:421–428.
  • Schutta KM, Burnett CB. Factors that influence a patient's decision to participate in a phase I cancer clinical trial. Oncol Nurs Forum. 2000;27:1435–1438.
  • Ferrel BR, Coyle N. Oxford Textbook of Palliative Nursing. New York: Oxford University Press; 2010:975–980.
  • Kummar S, Rubinstein L, Kinders R, Phase 0 clinical trials: conceptions and misconceptions. Cancer J. 2008;14:133–137.
  • Truong TH, Weeks JC, Cook EF, Joffe S. Altruism among participants in cancer clinical trials. Clin Trials. 2011;8:616–623.
  • Appelbaum PS, Roth LH, Lidz C. The Therapeutic misconception: informed consent in psychiatric research. Int J Law Psychiatry. 1982;5:319–329.
  • National Bioethics Advisory Commission. Ethical and policy issues in international research: clinical trials in developing countries. Available at: http://bioethics.georgetown. edu/nbac/pubs.html. Published 2001. Accessed December 5, 2011.
  • Horng S, Grady C. Misunderstanding in clinical research: distinguishing therapeutic misconception, therapeutic misestimation, and therapeutic optimism. IRB. 2003;25:11–16.
  • Joffe S, Cook EF, Cleary PD, Clark JW, Weeks JC. Quality of informed consent in cancer clinical trials: a cross-sectional survey. Lancet. 2001;358:1772–1777.
  • Daugherty CK, Banik DM, Janish L, Ratain MJ. Quantitative analysis of ethical issues in phase I trials: a survey interview study of 144 advanced cancer patients. IRB. 2000;22: 6–14.
  • Markman M. Therapeutic Intent and misconception in early-phase clinical trials in the gynecologic malignancies. Int J Gynecol Cancer. 2010;20:311–312.
  • Kass NE. Early phase clinical trials: communicating the uncertainties of ‘magnitude of benefit’ and ‘likelihood of benefit.’ Clin Trials. 2008;5:627–629.
  • Jenkins V, Solis-Trapala I, Langridge C, What oncologists believe they said and what patients believe they heard: an analysis of phase I trial discussions. J Clin Oncol. 2011; 29:61–68.
  • Miller FG, Joffe S. Benefit in phase 1 oncology trials: therapeutic misconception or reasonable treatment option? Clin Trials. 2008;5:617–623.
  • Ganguli-Mitra A, Biller-Andorno N. (2011). Vulnerability in healthcare and research ethics. The SAGE Handbook of Health Care Ethics, 239–251.
  • Denny, Colleen. “Research Involving Women.” The Oxford Textbook of Clinical Research Ethics. (2008):407–423.
  • Horng S, Emanuel EJ, Wilfond B. Descriptions of benefits and risks in consent forms for phase 1 oncology trials. N Engl J Med. 2002;347:2134–2140.
  • National Bioethics Advisory Commission (NBAC). Ethical and Policy Issues in Research Involving Human Participants. Vol. 1. Washington DC; New York, NY. National Bioethics Advisory Commission; 2001:88.
  • Menikoff J. The vulnerability of the very sick. J Law Med Ethics. 2009;37(Spring):51–58.
  • Seidenfeld J, Horstmann E, Emanuel EJ, Grady C. Participants in phase 1 oncology research trials—are they vulnerable? Arch Intern Med. 2008;168:16–20.
  • Joffe S, Miller FG. Rethinking risk-benefit assessment for phase I cancer trials. J Clin Oncol. 2006;24:2987–2990.
  • Nurgat ZA, Craig W, Campbell NC, Patient motivations surrounding participation in phase I and phase II clinical trials of cancer chemotherapy. Br J Cancer. 2005;92:1001–1005.
  • Annas GJ. The changing landscape of human experimentation: Nuremberg, Helsinki, and beyond. Health Matrix Clevel. 1992;2(Summer):119–140.
  • Caplan A. Is it sound public policy to let the terminally ill access experimental medical innovations? Am J Bioeth. 2007;7:1–3.
  • Cohen MZ, Slomka J, Pentz RD, Phase I participants’ views of quality of life and trial participation burdens. Support Care Cancer. 2007;15:885–890.
  • Decoster G, Stein G, Holdener EE. Responses and toxic deaths in phase I clinical trials. Ann Oncol. 1990;1:175–181.
  • Roberts TG Jr, Goulart BH, Squitieri L, Trends in the risks and benefits to patients with cancer participating in phase 1 clinical trials. JAMA 2004;292:2130–2140.
  • Arkenau HT, Olmos D, Ang JE, Clinical outcome and prognostic factors for patients treated within the context of a phase I study: the Royal Marsden Hospital experience. Br J Cancer. 2008;98:1029–1033.
  • Miller FG, Joffe S. Benefit in phase 1 oncology trials: therapeutic misconception or reasonable treatment option? Clin Trials. 2008;5:617–623.
  • Weinfurt KP, Seils DM, Tzeng JP, Expectations of benefit in early-phase clinical trials: implications for assessing the adequacy of informed consent. Med Decis Mak. 2008;28:575–581.
  • Segen JC, ed. Concise Dictionary of Modern Medicine. xx: McGraw-Hill; 2006:458.
  • Weijer C, Miller PB. When are research risks reasonable in relation to anticipated benefits? Nat Med. 2004;10:570–573.
  • Nycum G, Reid L. The harm-benefit tradeoff in “bad deal” trials. Kennedy Inst Ethics J. 2007;17:321–350.
  • Horng S, Emanuel EJ, Wilfond B, Descriptions of benefits and risks in consent forms for phase 1 oncology trials. N Engl J Med. 2002;347:2134–2140.
  • Meropol NJ, Weinfurt KP, Burnett CB, Perceptions of patients and physicians regarding phase I cancer clinical trials: implications for physician-patient communication. J Clin Oncol. 2003;21:2589–2596.
  • Flynn KE, Weinfurt KP, Seils DM, Decisional conflict among patients who accept or decline participation in phase I oncology studies. J Empir Res Hum Res Ethics. 2008;3: 69–77.
  • 21 Code of Federal Regulations 50, 20.
  • Sankar P. Communication and miscommunication in informed consent to research. Med Anthropol Q. 2004;18:429–446.
  • Harris L, Views of informed consent and decision-making: parallel views of physicians and the public. In: President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, Making Health Care Decisions. Vol. 2. Washington, DC: Government Printing Office; 1982:17–316.
  • Applebaum PS. Clarifying the ethics of clinical research: a path toward avoiding the therapeutic misconception. Am J Bioeth. 2002;2(Spring):22–23.
  • Horng S, Emanuel EJ, Wilfond B, Descriptions of benefits and risks in consent forms for phase 1 oncology trials. N Engl J Med. 2002;347:2134–2140.
  • Horstmann E, McCabe MS, Grochow L, Risks and benefits of phase 1 oncology trials, 1991 through 2002. N Engl J Med. 2005;352:895–904.
  • Weinfurt KP, Seils DM, Tzeng JP, Expectations of benefit in early-phase clinical trials: implications for assessing the adequacy of informed consent. Med Decis Mak. 2008;28:575–581.
  • Horstmann E, McCabe MS, Grochow L, Risks and benefits of phase 1 oncology trials, 1991 through 2002. N Engl J Med. 2005;352:895–904.
  • Daugherty CK, Siegler M, Ratain MJ, Zimmer G. Learning from our patients: one participant's impact on clinical trial research and informed consent. Ann Intern Med. 1997;126:892–897.
  • Flynn KE, Weinfurt KP, Seils DM, Decisional conflict among patients who accept or decline participation in phase I oncology studies. J Empir Res Hum Res Ethics. 2008;3:69–77.
  • Markman M. Further evidence of clinical benefit associated with participation in phase I oncology trials. Br J Cancer. 2008;98:1021–1022.
  • Koyfman SA, Agrawal M, Garret-Mayer E, Risks and benefits associated with novel phase 1 oncology trial designs. Cancer. 2007;110:1115–1124.
  • Nurgat ZA, Craig W, Campbell NC Patient motivations surrounding participation in phase I and phase II clinical trials of cancer chemotherapy. Br J Cancer. 2005;92:1001–1005.
  • Sulmasy DP, Astrow AB, He MK, The culture of faith and hope. patients’ justifications for their high estimations of expected therapeutic benefit when enrolling in early phase oncology trials. Cancer. 2010;116:3702–3711.
  • Agrawal M, Fairclough D, Grady C, Decision-making process of participants of phase I oncology trials. J Clin Oncol. 2006;24:4479–4484.
  • Prelec D, Loewenstein G. Decision making over time and under uncertainty: a common approach. Manage Sci. 1991;37:770–786.
  • Hall KH. Reviewing intuitive decision-making and uncertainty: the implications for medical education. Med Educ. 2002;36:216–224.
  • Kahneman D. Maps of bounded rationality: psychology for behavioral economics. Am Econ Rev. 2003;93:1449–1475.
  • Djulbegovic B. Uncertainty and equipoise: at interplay between epistemology, decision-making and ethics. Am J Med Sci. 2011;342:282–289.
  • Finucane ML, Alhakami A, Slovic P, Johnson SM. The affect heuristic in judgments of risks and benefits. J Behav Decis Mak. 2000;13:1–17.
  • Kahneman D, Tversky A. Prospect theory: an analysis of decision under risk. Econometrica. 1979;47(2):263–291.
  • Rasiel EB, Weinfurt KP, Schulman KA. Can prospect theory explain risk-seeking behavior by terminally ill patients? Med Decis Mak. 2005;25:609–613.
  • Winter L, Moss MS, Hoffman C. Affective forecasting and advance care planning anticipating quality of life in future health statuses. J Health Psychol. 2009;14:447–456.
  • Loewenstein G. Hot-cold empathy gaps and medical decision making. Health Psychol. 2005;24(4 Suppl):S49–S56.
  • Reyna VF, Nelson WL, Han PK, Dieckmann NF. How numeracy influences risk comprehension and medical decision making. Psychol Bull. 2009;135:943–973.
  • Nelson W, Reyna VF, Fagerlin A, Lipkus I, Peters E. Clinical implications of numeracy: theory and practice. Ann Behav Med. 2008;35:261–274.
  • Druckman JN. On the limits of framing effects: who can frame? J Politics. 2001;63:1041–1066.
  • McNeil BJ, Pauker SG, Sox HC Jr, Tversky A. On the elicitation of preferences for alternative therapies. N Engl J Med. 1982;306:1259–1262.
  • Ditto PH, Hawkins NA. Advance directives and cancer decision making near the end of life. Health Psychol. 2005;24(4 Suppl):S63–S70.
  • Drought TS, Koenig BA. “Choice” in end-of-life decision making researching fact or fiction? Gerontologist. 2002;42(Special No. 3):114–128.
  • Weiner JS, Roth J. Avoiding iatrogenic harm to patient and family while discussing goals of care near the end of life. J Palliat Med. 2006;9:451–463.
  • Kohara I, Inoue T. Searching for a way to live to the end: decision-making process in patients considering participation in cancer phase I clinical trials. Oncol Nurs Forum. 2010;37:E124–E132.
  • Zafar SY, Alexander SC, Weinfurt KP, Schulman KA, Abernethy AP. Decision making and quality of life in the treatment of cancer: a review. Support Care Cancer. 2009;17:117–127.
  • Casarett DJ. Assessing decision-making capacity in the setting of palliative care research. J Pain Symptom Manage. 2003;25:S6–S13.
  • Henry B, Scales DC. Ethical challenges in conducting research on dying patients and those at high risk of dying. Account Res. 2012;19:1–12.
  • Daugherty CK, Siegler M, Ratain MJ, Zimmer G. Learning from our patients: one participant's impact on clinical trial research and informed consent. Ann Intern Med. 1997;126:892–897.
  • Benson PR, Roth LH, Appelbaum PS, Lidz CW, Winslade WJ. Information disclosure, subject understanding, and informed consent in psychiatric research. Law Hum Behav. 1988;12:455–475.
  • Dean RA, McClement SE. Palliative care research: methodological and ethical challenges Int J Palliat Nurs. 2002;8:376–380.
  • Casarett DJ, Karlawish JHT. Are special ethical guidelines needed for palliative care research? J Pain Symptom Manage. 2000;20:130–139.
  • Horng S, Emanuel EJ, Wilfond B. Descriptions of benefits and risks in consent forms for phase 1 oncology trials. N Engl J Med. 2002;347:2134–2140.
  • Nitschke R. Physician–patient communication in phase I cancer trials. J Clin Oncol. 2004;22:571–572.
  • Buss MK, Arnold RM. Challenges in palliative care research: one experience. J Palliat Med. 2004;7:405–407.
  • Kass NE, Sugarman J, Medley AM, An intervention to improve cancer patients’ understanding of early-phase clinical trials. IRB. 2009;31:1–10.
  • Tomamichel M, Sessa C, Herzig S, Informed consent for phase I studies: evaluation of quantity and quality of information provided to patients. Ann Oncol. 1995;6:363–369.
  • Fine PG. Maximizing benefits and minimizing risks in palliative care research that involves patients near the end of life. J Pain Symptom Manage. 2003;25:S53–S62.
  • National Comprehensive Cancer Network site. Available at: www.nccn.org. Accessed September 4, 2013.
  • Casarett D, Kassner CT, Kutner JS. Recruiting for research in hospice: feasibility of a research screening protocol. J Palliat Med. 2004;7:854–860.
  • Wright DN, Hopkinson JB, Corner JL, Foster CL. How to involve cancer patients at the end of life as co-researchers. Palliat Med. 2006;20:821–827.
  • Williams AL, Selwyn PA, McCorkle R, Application of community-based participatory research methods to a study of complementary medicine interventions at end of life. Complement Health Pract Rev. 2005;10:91–104.

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