Phase 1 clinical trials in end-stage cancer: patient understanding of trial premises and motives for participation
- 659 Downloads
In cancer, phase 1 clinical trials on new drugs mostly involve patients with advanced disease that is unresponsive to standard therapy. The purpose of this study was to explore the difficult ethical problems related to patient information and motives for participation in such trials.
A descriptive and explorative qualitative design was used. Fourteen cancer patients from three different phase 1 trials in end-stage cancer were interviewed. The interviews were analysed using qualitative content analysis.
The patients expressed unrealistic expectations of therapeutic benefit and inadequate understanding of the trials’ purpose, so-called therapeutic misconception. However, they reported a positive attitude towards participation. Thus, the patients valued the close and unique medical and psychological attention they received by participating. Participation also made them feel unique and notable.
Patients with end-stage cancer participating in phase 1 clinical trials are unaware of the very small potential for treatment benefit and the risk of harm. Trial participation may offer hope and social–emotional support and a strategy for coping with the emotional stress associated with advanced cancer and may, consequently, improve emotional well-being.
KeywordsCancer Clinical trials Ethics Sweden
The investigators wish to thank the trial participants for taking the time to participate in this study and for sharing their experiences and thoughts. We also thank the research nurses at the Research and Development Unit at Uppsala University Hospital and Clinical Trial Unit at Karolinska University Hospital, for their assistance with patient recruitment. This work was supported by grants from the Swedish Cancer Society.
Conflict of interest
The authors have declared no conflicts of interest.
- 2.Beauchamp TL, Childress JF (2009) Principles of biomedical ethics. Oxford University Press, New YorkGoogle Scholar
- 8.Eriksson K (2001) Vårdvetenskap som akademisk disciplin. (Health care science as an academic discipline). Åbo Akademi University, TurkuGoogle Scholar
- 18.Kvale S (1997) Den kvalitativa forskningsintervjun. Studentlitteratur, LundGoogle Scholar
- 19.Kvale S (2007) Doing interviews. Sage, Thousand OaksGoogle Scholar
- 22.Meropol NJ, Weinfurt KP, Burnett CB, Balshem A, Benson AB, Castel L, Corbett S, Diefenbach M, Gaskin D, Li Y, Manne S, Marshall J, Rowland JH, Slater E, Sulmasy DP, Van Echo D, Washington S, Schulman KA (2003) Perceptions of patients and physicians regarding phase I cancer clinical trials: implications for physician–patient communication. J Clin Oncol 21:2589–2596PubMedCrossRefGoogle Scholar
- 25.Patton MQ (2002) Qualitative research and evaluation methods. Sage, LondonGoogle Scholar
- 27.Stolberg SG (2000) Teenager’s death is shaking up field of human gene-therapy experiments. New York Times, New YorkGoogle Scholar